Nicola P. Klein, MD, PhD

Simultaneous RSV prevention antibody (nirsevimab) and other childhood vaccines in infants study – Contributing Site

Assist in design of a prospective, randomized clinical trial to assess the safety of simultaneous administration of nirsevimab (RSV monoclonal antibody) and routine childhood vaccines in infants 6 weeks to  8 months of age. KPNC shall enroll participants, follow up with participants, and collect data from participants enrolled as part of the clinical trial.

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Investigator: Klein, Nicola

Funder: Centers for Disease Control and Prevention

Phase III, randomized, single-blind, placebo-controlled, multi-center study to evaluate non-interference of concomitant administration of routine pediatric vaccines on the antibody response of an investigational live-attenuated respiratory syncytial virus in infants and toddlers

This phase III, randomized, single-blind, placebo-controlled, multi-center study will evaluate non-interference of concomitant administration of routine pediatric vaccines on the antibody response of an investigational live-attenuated respiratory syncytial virus in infants and toddlers.

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Investigator: Klein, Nicola

Funder: Sanofi

A master phase 1/2/3 protocol to investigate the safety, tolerability, and immunogenicity of variant-adapted BNT162b2 RNA-based vaccine candidate(s) in healthy children

This study will describe the safety and tolerability profiles of prophylactic variant-adapted BNT162b2 at each dose level and variant-adapted vaccine type (if applicable) in COVID-19 vaccine-naive participants 6 months to 5 years of age.

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Investigator: Klein, Nicola

Funder: Pfizer Inc.

Clinical Immunization Safety Assessment (CISA) IDIQ

We will provide clinical consultations to the CDC for vaccine safety cases, perform clinical case reviews and evaluation of vaccine safety issues, and coordinate activities to support these functions.

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Investigator: Klein, Nicola

Funder: Centers for Disease Control and Prevention

CISA Clinical Evaluation (Contributing) CISA Clinical Vaccine Safety Evaluation – Contributing

We will provide clinical consultations to the CDC for vaccine safety cases, perform clinical case reviews and evaluation of vaccine safety issues, and coordinate activities to support these functions. We also will research studies to advance knowledge of vaccine safety and inform clinical and public health practices.

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Investigator: Klein, Nicola

Funder: Centers for Disease Control and Prevention

A Phase II, single-blind, randomized, controlled study to evaluate the immunogenicity and safety of a measles, mumps, rubella, varicella vaccine compared with ProQuad, administered in healthy children 4 to 6 years of age

This study will evaluate the immune response to the MMRVNS vaccines (formulated with different potencies) and the MMRV vaccine (pooled group) in terms of GMCs for antibodies to measles, mumps, rubella, and varicella viruses.

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Investigator: Klein, Nicola

Funder: IQVIA RDS Inc.

Beyfortus (nirsevimab) Effectiveness Against RSV Medically-Attended Events in Infants (BEAR Study)

This study will estimate the effectiveness of Beyfortus (nirsevimab) against PCR-confirmed RSV with a lower respiratory tract disease diagnosis & to estimate the effectiveness of nirsevimab against medical encounters for PCR-confirmed RSV with lower respiratory tract disease.

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Investigator: Klein, Nicola

Funder: Sanofi

Safety of Tetanus, Diphtheria, Acellular Pertussis with 5 Acellular Pertussis Components (Tdap5) Vaccination during Pregnancy: A Cohort Study using US Electronic Health Record Data

The primary objective of this study is to further evaluate the safety of Adacel vaccine among pregnant individuals exposed to Adacel during the third trimester of pregnancy and their offspring with regards to pre-defined pregnancy, birth, and neonatal outcomes.

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Investigator: Klein, Nicola

Funder: Sanofi Pasteur S.A.

A Virtual Network to Investigate the Effectiveness of COVID-19 and influenza vaccines and evaluate the burden and epidemiology of respiratory viruses

This project’s core objectives are: 1) assessing COVID-19, influenza and RSV testing frequency, test type, and test results across age groups, care settings, disease severity, and population subgroups; 2) assessing COVID-19 and influenza VE across age groups, care settings, disease severity, and population subgroups; when RSV vaccines are available, evaluating RSV VE in eligible persons; 3) assessing COVID-19, influenza, and RSV vaccination coverage by dose number and product type; 4) describing the epidemiology and clinical characteristics of COVID-19, influenza, and RSV across age groups, care settings, disease severity, and population subgroups; 5) describing the trajectory of care for individuals with COVID-19, influenza, and RSV including severe outcomes and post-acute sequelae; and 6) assessing use of therapies for the treatment and prophylaxis for COVID-19, influenza, and RSV, and impact of these therapies in preventing illness and/or attenuating disease severity.

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Investigator: Klein, Nicola

Funder: Centers for Disease Control and Prevention

A Prospective Observational Study to Evaluate the Safety of COVID-19 Vaccination in Children and Adolescents

Kaiser Permanente will recruit 20 participants (ages 5 to 16 years old) into the CISA COVID-19 Pediatrics study during the period of performance of (07/25/2022 through 9/2/2022).

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Investigator: Klein, Nicola

Funder: Centers for Disease Control and Prevention

A Phase IIIB, Randomized, Observer-blind, Multicenter Study to Assess the Safety and lmmunogenicity of GSK Meningococcal Group B Vaccine when Administered Concomitantly with GSK Meningococcal MenACWY Conjugate Vaccine to Healthy Subjects 16-18

This study will assess the safety and tolerability of rMenB+OMV NZ and MenACWY vaccines when administered concomitantly or alone in healthy subjects 16-18 years of age.

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Investigator: Klein, Nicola

Funder: GlaxoSmithKline PLC

Pediatric COVID-19 Vaccination RCT in Young Children

We are providing technical expertise, consultation, and enrolling participants in a randomized clinical trial to evaluate the safety of simultaneous mRNA COVID-19 vaccine with other childhood vaccines in young children aged 6 months to 5 years.

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Investigator: Klein, Nicola

Funder: Centers for Disease Control and Prevention

VSD Infrastructure

We conduct administrative tasks, data management, and contribute to vaccine safety assessments to support the management and development of the ongoing work of the VSD. This includes
producing and maintaining a high-quality electronic data infrastructure encompassing health plan members of
all ages that is accessible through a distributed data model.

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Investigator: Klein, Nicola

Funder: Centers for Disease Control and Prevention

Effectiveness of Adacel Vaccination in Pregnancy in Preventing Infant Pertussis

This observational cohort study will determine the effectiveness of the Adacel vaccine against pertussis disease in infants aged 2 months and 1 year when administered at any time during pregnancy.

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Investigator: Klein, Nicola

Funder: Sanofi Pasteur S.A.

A Phase 1, Open-Label Dose-Finding Study to Evaluate Safety, Tolerability, and Immunogenicity Study of a Sars-Cov-2 RNA Vaccine Candidate Against Covid-19 in Healthy Children 12 Years of Age

This phase I open-label dose-finding study will evaluate the safety, tolerability, and immunogenicity of a Sars-Cov-2 RNA vaccine candidate against COVID-19 in healthy 12-year-old children.

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Investigator: Klein, Nicola

Funder: Pfizer Inc.

A Phase 3 International, Multicenter, Open-label Study to Evaluate the Safety and Immunogenicity of 9vHPV Vaccine Administered as 2-dose Regimen with Extended Dosing Intervals in 9- to 14-Year-Old Boys and Girls Compared with a Standard 3-dose

This study will evaluate extended 2-dose regimens in boys and girls ages 10 to 15 who previously received 1 dose of 9vHPV vaccine and did not complete the series and in HPV vaccine-naive boys and girls ages 9 to 14. Both groups will be compared with young women ages 16 to 26 who receive a standard 3-dose vaccine regimen.

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Investigator: Klein, Nicola

Funder: Merck ＆ Company, Inc.

Long-term Outcomes Associated with Extended-Interval Dosing of the 9vHPV Vaccine: a Prospective, Observational Cohort Study Supplementary to V503-069 Clinical Trial

This prospective, observational cohort study, an extension of clinical trial V503-069, will enroll and administer a second dose of 9vHPV to approximately 200 children/teens ages 10 to 15 who received their first 9vHPV vaccine at least 1 year prior. These children/teens will be followed for 6 years via electronic medical record and e-survey to assess long-term outcomes associated with extended-interval dosing schedules on the incidence and prevalence of genital warts; assess reasons of non-compliance to the 9vHPV vaccine schedule; and assess the association between sexual behavior and genital warts.

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Investigator: Klein, Nicola

Funder: Merck ＆ Company, Inc.

A Phase 3 Master Protocol to Evaluate Additional Dose(s) of BNTJ 62b2 in Healthy Individuals Previously Vaccinated with BNTJ 62b2

This study will evaluate the safety, tolerability, and efficacy of a booster dose of BNT162b2 when administered to study participants who previously received 2 doses of BNT162b2 at least 6 months prior to randomization.

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Investigator: Klein, Nicola

Funder: Pfizer Inc.

Phase 3 Study to Evaluate the Lot Consistency, Safety, Tolerability, and Immunogenicity of the Vaccine Candidate BNT162b2 Against COVID-19 in Healthy Adults

To demonstrate that the immune responses induced by BNT162b2 are consistent across the 3 U.S. lots (Lots 1, 2, and 3) in participants without evidence of SARS-CoV-2 infection during the study.

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Investigator: Klein, Nicola

Funder: Pfizer Inc.

Phase 3 Study to Evaluate the Safety and Immunogenicity of 9vHPV Vaccine in 9- to 14-Year Old Boys and Girls

This study will evaluate extended 2-dose regimens in 2 different populations: (1) boys and girls 10 to 15 years of age who previously received 1 dose of 9vHPV vaccine and did not complete the series and (2) HPV vaccine-naive boys and girls 9 to 14 years of age compared with young women 16 to 26 years of age who receive a standard 3-dose vaccine regimen.

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Investigator: Klein, Nicola

Funder: Merck ＆ Company, Inc.

COVID-19 Infrastructure and Activities Vaccine Safety Datalink Project

This work will support and contribute to the COVID-19 vaccine safety work of the VSD: managing site contributions, and participating on working groups and attending conference calls; providing high-quality electronic data for COVID-19 vaccine safety activities; participation on vaccine safety monitoring and evaluation studies; conducting medical record reviews.

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Investigator: Klein, Nicola

Funder: Centers for Disease Control and Prevention

Genome Sequencing Study, Flublock Quadrivalent Vaccine

Study will perform sequencing on 300 specimens from a mixture of Flublok Quadrivalent vaccine recipients, SD-IIV4 recipients, and unvaccinated individuals; and describe the molecular epidemiology of approximately 300 influenza strains causing disease in vaccinated (Flublok Quadrivalent vaccine and SD-IIV4) and unvaccinated individuals.

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Investigator: Klein, Nicola

Funder: Sanofi Pasteur S.A.

Rapid Cycle Analysis for COVID-19 Vaccines in Vaccine Safety Datalink

We will develop a protocol, coordinate, and lead Rapid Cycle Analysis (RCA) activities in order to monitor the safety of COVID-19 vaccines in near real-time and investigate possible associations between the COVID-19 vaccines and a pre-specified list of adverse events for the Centers for Disease Control and Prevention.

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Investigator: Klein, Nicola

Funder: Centers for Disease Control and Prevention

A Phase 3, Randomized, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a 20-Valent Pneumococcal Conjugate Vaccine in Healthy Infants

This study is part of the Phase 3 pediatric clinical development program to evaluate the 20-Valent Pneumococcal Conjugate Vaccine for use in infants and children. This clinical trial will provide key safety and pivotal comparative immunogenicity data in infants to support licensure in this population.

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Investigator: Klein, Nicola

Funder: Pfizer Inc.

A Phase 1/2/3, Placebo-controlled, Randomized, Observer-blind, Dose-finding Study to Describe the Safety, Tolerability, Immunogenicity, and Potential Efficacy of SARS-Co V-2 RNA Vaccine Candidates Against COVID-19 in Healthy Adults

To describe the safety and tolerability profiles of prophylactic BNT162 vaccines in healthy adults after 1 or 2 doses

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Investigator: Klein, Nicola

Funder: Pfizer Inc.

Innovative Methods to Inform Estimates of Vaccine Effectiveness Using Information on the Epidemiology and Incidence of Influenza and Other Acute Respiratory Illnesses

This study will estimate influenza vaccine effectiveness by vaccine type and for different ages by combining data from medical records, vaccine registries, and results of clinician-ordered molecular tests for influenza virus infection at Kaiser Permanente Northern California.

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Investigator: Klein, Nicola

Funder: Centers for Disease Control and Prevention

A Phase 3 Trial to Evaluate the Safety and Immunogenicity of 3 Lots of 20-Valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-Naive Adults 18 through 49 Years of Age

A phase 3, randomized, double-blind trial will evaluate the safety and immunogenicity of 3 lots of 20-valent Pneumococcal conjugate vaccine in Pneumococcal vaccine­­­–naive adults 18 through 49 years of age. The purpose of this study is to evaluate the safety and consistency of immune response elicited across 3 different lots of 20vPnC.

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Investigator: Klein, Nicola

Funder: ICON Clinical Research PLC

A Phase 3 Study to Evaluate the Safety and Tolerability of V114 in Healthy Infants (PNEU-LINK)

The primary objective of this study is to evaluate the safety and tolerability of V114 with respect to the proportion of participants with adverse events. Secondary objectives are:
1) To evaluate the anti-pneumococcal polysaccharide serotype-specific Immunoglobulin Geometric Mean Concentrations at 30 days following dose 3, prior to dose 4, and at 30 days following dose 4 for each vaccination group; and
2) To evaluate the anti-PnPs serotype-specific IgG response rates.

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Investigator: Klein, Nicola

Funder: Merck ＆ Company, Inc.

Shingrix Lead Site Evaluating the Effectiveness of Recombinant Zoster Vaccine

The purpose of this project is, first, to estimate the proportion of the population under study receiving one and two doses of recombinant zoster vaccine (RZV). Second, among live zoster vaccine (ZVL)-naive persons, this study aims to: 1) estimate the vaccine effectiveness of one dose of RZV, 2) estimate the vaccine effectiveness of two doses of RZV in 50- to 64-year-olds and those aged 65 and above, and 3) calculate the incremental vaccine effectiveness of a complete series (two-dose vaccine effectiveness versus one-dose vaccine effectiveness). Lastly, this study aims to estimate the vaccine effectiveness of one-dose RZV and of two-dose RZV among persons who previously received ZVL, as well as among immunocompromised persons.

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Investigator: Klein, Nicola

Funder: Centers for Disease Control and Prevention

Examining Vaccine Effectiveness of Flublok Relative to Standard Dose Inactivated Influenza Vaccine Among Kaiser Permanente Northern California Members Aged 18-64 Years

This study employs a cluster randomization design to examine the vaccine effectiveness of Flublok relative to that of other flu vaccines used at Kaiser Permanente Northern California over two influenza seasons (2018 to 2019 and 2019 to 2020), in Kaiser Permanente Northern California members aged 18 to 64 years (comparator vaccines will not include high-dose or live vaccines). The primary age group of interest is 50- to 64-year-olds. Primary outcomes may include: 1) an influenza diagnosis confirmed by polymerase chain reaction (PCR) test as positive for influenza (A or B), 2) hospitalization with a PCR-confirmed influenza diagnosis regardless of the principal discharge diagnosis, and 3) hospitalization for pneumonia in December through March (regardless of whether there is a PCR test). Secondary outcomes may include other flu-related events, such as cardiovascular events (e.g., myocardial infarction or stroke) and other respiratory outcomes.

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Investigator: Klein, Nicola

Funder: Protein Sciences Corporation

A Phase IIIB Study to Assess the Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine when Administered Concomitantly with Routine Vaccines to Healthy Infants

This is a phase IIIB, observer-blind, randomized, placebo-controlled, multi-center study to assess the safety and immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine when administered concomitantly with routine vaccines to healthy infants

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Investigator: Klein, Nicola

Funder: GlaxoSmithKline PLC

Statistical Analysis Studies Comparing Flucelvax to Egg-Based Influenza Vaccinations

This study has three primary aims: 1) to estimate the relative vaccine effectiveness of Flucelvax versus inactivated influenza vaccine (IIV) in vaccinated Kaiser Permanente Northern California members aged 4 to 64 years against all PCR-confirmed influenza A5; 2) to estimate the vaccine effectiveness of Flucelvax against all PCR-confirmed influenza A, comparing Flucelvax vaccinees versus unvaccinated in Kaiser Permanente Northern California members aged 4 to 64 years; and 3) to estimate the vaccine effectiveness of IIV (not including Flucelvax) against all PCR-confirmed influenza A, comparing IIV vaccinees versus unvaccinated Kaiser Permanente Northern California members aged 4 to 64 years. Secondary aims are 1) to estimate the relative vaccine effectiveness of Flucelvax versus trivalent influenza vaccine (TIV) in vaccinated Kaiser Permanente Northern California members aged 4 to 64 years against all PCR-confirmed influenza B; and 2) to estimate the relative vaccine effectiveness of Flucelvax versus IIV in vaccinated Kaiser Permanente Northern California members aged 4 to 64 years against PCR-confirmed hospitalized influenza A.

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Investigator: Klein, Nicola

Funder: Shoo the Flu, LLC

A Continuation of Assessment of the Impact of Prevnar 13 on Invasive Pneumococcal Disease Caused by Vaccine Serotypes of Streptococcus pneumoniae After Introduction Into Routine Pediatric and Adult Use for the Period of May 2015 – April 2020

This project will estimate Prevnar 13 (PCV13) vaccine effectiveness against invasive pneumococcal disease using a test-negative design in the Kaiser Permanente Northern California adult population from September 1, 2014, through December 31, 2017. Positive cases will be defined as patients with invasive pneumococcal disease where serotype 3 is identified. Test-negative controls will be defined as patients with invasive pneumococcal disease where a non-PCV serotype is identified. As a sensitivity analysis, the vaccine effectiveness of Prevnar 13 against invasive pneumococcal disease caused by serotype 3 will also be compared with the vaccine effectiveness of 23-valent pneumococcal polysaccharide vaccine (PPV23) serotypes against invasive pneumococcal disease. In addition, invasive pneumococcal disease cases will be compared with the entire Kaiser Permanente Northern California adult population with similar characteristics matched on age, race, sex, and calendar time to better understand vaccination rates among different serotypes.

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Investigator: Klein, Nicola

Funder: Pfizer Inc.

A Phase 2, Randomized, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine in Healthy Infants

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Investigator: Klein, Nicola

Funder: ICON Clinical Research PLC

Continuation of Group B Streptococcus Epidemiology Study (Phase II)

Kaiser Permanente Northern California has recently collaborated with Pfizer in identifying invasive and noninvasive group B streptococcus (GBS) disease burden in adults during a seven-year time period spanning 2007 to 2014. In Phase 1 of this research collaboration, comorbid medical conditions in subjects with GBS disease were identified. In Phase 2 of this research collaboration, the burden of invasive and/or noninvasive GBS disease among subjects with the most commonly identified medical conditions identified in Phase 1 will be evaluated. These data will inform potential future study populations for the evaluation of a GBS vaccine in adults. The objective is to identify populations at highest risk for GBS disease (invasive and noninvasive) based on the pre-specified medical conditions and age groups from the Phase 1 analyses. Prediction models for patient risks of GBS will be developed, and with the models, each risk factor and combination of risk factors will be evaluated.

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Investigator: Klein, Nicola

Funder: Pfizer Inc.

California Emerging Infections Program

The goal of this project is to determine the age-specific rates of laboratory-confirmed influenza-associated hospitalization among children, and to describe clinical and epidemiologic characteristics of pediatric hospitalized case-patients during the influenza season.

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Investigator: Klein, Nicola

Funder: Centers for Disease Control and Prevention

Predictors of Pneumococcal Vaccination, Pneumococcal Vaccine Effectiveness, and Trends in Pneumonia

The three objectives of this study are to: 1) Identify and compare the clinical, demographic and neighborhood characteristics associated with receipt of pneumococcal vaccine among persons 65 years of age and older, and among persons 18 to 64 years of age with risk conditions (at-risk and high-risk); 2) Estimate the effectiveness of 13-valent pneumococcal conjugate vaccine (PCV13) and 23-valent pneumococcal polysaccharide vaccine (PPSV23) in preventing health care utilization for invasive pneumococcal disease, lower respiratory tract infections, and all-cause pneumonia in persons 18 to 64 years of age and in persons 65 years of age and older; and 3) Identify cases of all-cause pneumonia and lower respiratory tract infections , and describe trends in the incidence of health care services utilization under different definitions in persons 18 to 64 years of age with risk conditions (at-risk and high-risk) and in persons 65 years of age and older in the Kaiser Permanente Northern California population.

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Investigator: Klein, Nicola

Funder: Pfizer Inc.

Hosting a Hub Server for the Vaccine Safety Datalink

The hub server is used to transfer programs and related files to Vaccine Safety Datalink (VSD) sites from the Centers for Disease Control and Prevention (CDC), and to transfer output from these programs back to CDC. The hub provides a common point that can be accessed by both CDC and participating VSD sites. The purpose of the hub is to provide a secure centralized location to transfer programs and output between CDC and the VSD sites.

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Investigator: Klein, Nicola

Funder: Centers for Disease Control and Prevention

A Phase 3, Randomized Study of a Two-Dose Bivalent Rlp2086 Regimen and a First-In-Human Study of the MenABCWY Vaccine

This study is a phase 3, randomized, active-controlled, observer-blinded study to assess the immunogenicity, safety, and tolerability of bivalent rLP2086 when administered as a two-dose regimen in healthy subjects 10 to 26 years of age. The project also includes a first-in-human study to describe the immunogenicity, safety, and tolerability of a bivalent rLP2086-containing pentavalent vaccine (MenABCWY) in healthy subjects 10 to 26 years of age.

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Investigator: Klein, Nicola

Funder: Pfizer Inc.

Clinical Immunization Safety Assessment (CISA), 1) Clinical Evaluation Activities and 2) Rapid Assessment of Post-Immunization Data (RAPID) Project

The purpose of this project is to provide the Centers for Disease Control and Prevention (CDC) Immunization Safety Office with an as-needed mechanism to obtain required services through the issuance of individual task orders in support of vaccine safety monitoring and evaluation that meet public health priorities for CDC. The CISA clinical consulting activity covers two CISA goals: a) To serve as a vaccine safety resource for consultation on clinical vaccine safety issues, including individual case reviews, and assist with immunization decision-making; and b) To assist CDC in developing strategies to assess individuals who may be at increased risk for adverse events following immunization. The purpose of the Rapid Assessment of Post-Immunization Data (RAPID) project is to conduct case-centered method analyses to assist with assessments of causality of adverse events following immunization.

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Investigator: Klein, Nicola

Funder: Centers for Disease Control and Prevention

A phase IIIA, randomized, single-blind, multi-centric study to evaluate the immunogenicity, reactogenicity and safety of three doses of Pediarix, Hiberix and Prevenar 13

A phase IIIA, randomized, single-blind, multi-centric study to evaluate the immunogenicity, reactogenicity and safety of three doses of Pediarix, Hiberix and Prevenar 13 when co-administered with two doses of the PCV-free liquid formulation of GSK Biologicals oral live attenuated HRV vaccine as compared to the currently licensed lyophilized formulation of the HRV vaccine in healthy infants 6-12 weeks of age.

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Investigator: Klein, Nicola

Funder: GlaxoSmithKline PLC

Safety Research of Currently Recommended Immunizations: Identifying Genetic, Immunologic and Clinical Factors Predisposing to Adverse Events after MMR Vaccine

The aims of this study are: 1) To determine genetic factors and immunologic patterns that may predict the occurrence of fever after measles vaccines by analyzing previously collected biospecimens during a randomized controlled MMR clinical trial. 2) To investigate for a familial clinical phenotype that predicts fever after MCV using KPVSC’s large pregnancy database to assess whether parental clinical risk factors are associated with fever in the child.

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Investigator: Klein, Nicola

Funder: Office of the Assistant Secretary for Health

A prospective, epidemiological, interventional, multi-country based, cohort study to assess the disease burden of respiratory syncytial virus (RSV) associated, suspected lower respiratory tract infections (LRTIs) in newborns, etc.

A prospective, epidemiological, interventional, multi-country based, cohort study to assess the disease burden of respiratory syncytial virus (RSV) associated, suspected lower respiratory tract infections (LRTIs) in newborns, etc.

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Investigator: Klein, Nicola

A Phase II, Double-Blind, Randomized, Multicenter Study to Evaluate the Safety, Tolerability and Immunogenicity of V114 Compared to Prevnar13 in Healthy Infants

A phase II, double-blind, randomized, multicenter study to evaluate the safety, tolerability, and immunogenicity of V114 compared to Prevnar13 in healthy infants.

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Investigator: Klein, Nicola

Funder: Merck ＆ Company, Inc.

A Phase 3, Placebo-Controlled, Randomized, Observer-Blinded Study to Evaluate the Efficacy, Safety and Tolerability of a Clostridium Difficile Vaccine in Adults 50 Years of Age and Older

Pfizer’s investigational Clostridium difficile vaccine (PF-06425090) is a prophylactic vaccine that is currently being investigated for the prevention of primary C difficile infection in adults 50 years of age and older.

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Investigator: Klein, Nicola

Funder: Pfizer Inc.

Impact of Eliminating Non-Medical Exemptions in California

The goal of this study is to develop an evidence base for the implementation of immunization legislation relating to exemptions. We will achieve this goal by addressing four specific aims: 1) Analyze rates, clustering and variances of immunization exemptions and conditional entrants before and after implementation of SB277; 2) Evaluate health care providers motivations, attitudes, beliefs and health care practice burden relating to vaccinations in the context of SB277; 3) Assess the determinants and implications of variability in implementation and enforcement of legislation at the school level; and 4) Ascertain the impact of SB277 on the rates of home schooling.

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Investigator: Klein, Nicola

Funder: National Institute of Allergy and Infectious Diseases

Post-Marketing Observational Study of Safety Following Vaccination with Flublok Compared to Licensed IIV in Adults 18 Years of Age and Older

Post-marketing observational study of safety following vaccination with Flublok compared to Licensed IIV in adults 18 years of age and older.

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Investigator: Klein, Nicola

Funder: Protein Sciences Corporation

A Phase III, Open Label, Multicenter Study of GSK Biological Herpes Zoster HZ/su Candidate Vaccine

A phase III, open label, multicenter study of GSK Biological herpes zoster HZ/su candidate vaccine (GSK1437173A) administered intramuscularly on a 0 and 2 month schedule evaluating the immunogenicity, safety and reactogenicity in adults 65 years of age with a previous Zostavax vaccination 5 years earlier, compared to group-matched adults not previously vaccinated with Zostavax.

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Investigator: Klein, Nicola

Funder: GlaxoSmithKline PLC

Post-Licensure Observational Safety Study of Gardasil 9

In December 2014, the FDA approved the Human Papillomavirus (HPV) 9-valent vaccine, Gardasil 9, for use in young males (9-15 years of age) and females (9-26 years of age). While clinical trials in large populations have shown that Gardasil 9 is generally safe and well tolerated, this observational study is being conducted by Merck and Co., Inc. as a post-licensure regulatory commitment to the FDA to monitor the general safety of Gardasil 9 when administered as part of routine health care.

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Investigator: Klein, Nicola

Funder: Merck ＆ Company, Inc.

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety And Efficacy of Staphylococcus Aureus 4-Antigen Vaccine (Sa4ag) in Adults Undergoing Elective Posterior Instrumented Lumbar Spinal Fusion Procedures

Clinical trial of staphylococcus aureus 4-Antigen vaccine.

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Investigator: Klein, Nicola

Funder: inVentiv Health Clinical, LLC

A Post Marketing Safety Study of Q/LAIV in Subjects 2 through 49 Years of Age

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Investigator: Klein, Nicola

Funder: MedImmune, LLC

Identifying Target Populations for an Investigational C. difficile Vaccine

C. difficile-associated disease’s (CDAD) clinical importance and its increasing incidence have resulted in C. difficile being a target for vaccine development. However, questions regarding which population may most benefit from receipt of a C. difficile vaccine remain. While CDAD is known to be associated with hospitalization, limited information exists regarding the burden of disease in specific populations such as those with underlying medical conditions. Further, the burden disease among those in long term care facilities and those in the outpatient setting is not well understood. The overall goal of this study is to identify potential at-risk groups which could be targeted to receive an investigational preventative C. difficile vaccine as part of a Phase 3 clinical trial.

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Investigator: Klein, Nicola

Funder: Pfizer Inc.

A Phase 3b, Controlled, Open-Label, Multi-Center Study to Evaluate Safety and Immunogenicity of a Single Dose of GSKs Meningococcal ACWY Conjugate Vaccine, Admin to Healthy Individuals 15 – 55 years of age, approx. 4-6 years after vaccination

A Phase 3b, Controlled, Open-Label, Multi-Center Study to Evaluate Safety and Immunogenicity of a Single Dose of GlaxoSmithKlines Meningococcal ACWY Conjugate Vaccine (Menveo), Administered to Healthy Individuals 15 through 55 years of age, approximately 4-6 years after primary ACWY vaccination, 205352 (V59_77).

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Investigator: Klein, Nicola

Funder: GlaxoSmithKline PLC

A phase III, open label, multicenter study to evaluate the impact of reactogenicity on Quality of Life (QoL), after intramuscular administration of GSK Biologicals candidate Herpes Zoster subunit (HZ/su) vaccine in adults 50 years of age

A phase III, open label, multicenter study to evaluate the impact of reactogenicity on Quality of Life (QoL), after intramuscular administration of GSK Biologicals candidate Herpes Zoster subunit (HZ/su) vaccine (GSK1437173A) in adults 50 years of age.

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Investigator: Klein, Nicola

Funder: GlaxoSmithKline PLC

Health Outcomes and Healthcare Resource Utilization Associated with Mild versus Moderate-to-Severe Laboratory-Confirmed Influenza in a Retrospective Cohort of US Children

This study will evaluate differences in health outcomes and healthcare resource utilization between moderate-to-severe influenza compared to mild influenza as defined by Jain et al 2013 in children aged 6 to 35 months in the US. Secondary objectives: To evaluate differences in health outcomes and healthcare resource utilization between moderate-to-severe influenza compared to mild influenza as defined by Jain et al 2013 in children aged 6 months to 18 years in the US, and to evaluate differences in health outcomes and healthcare resource utilization between moderate-to-severe influenza compared to mild influenza as defined by Jain et al 2013 in children aged 6 to 12 months in the US.

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Investigator: Klein, Nicola

Funder: GlaxoSmithKline PLC

Retrospective Cohort Study of Staphylococcus Aureus Surgical Site Infections in Patients Undergoing Elective Surgical Procedures in Kaiser Permanente Northern California (KPNC) Integrated Health System

This project will expand enrollment in an ongoing Staph vaccine trial. This will descriptive analyses of Staph infections following multiple types of surgeries, and risk factors associated with infection.

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Investigator: Klein, Nicola

Funder: Pfizer Inc.

Surgical Site Infection Rates for Patients Undergoing Elective Posterior Lumbar Spinal Fusion Surgery in Kaiser Permanente Northern California Hospitals

Surgical site infection rates for patients undergoing elective posterior lumbar spinal fusion surgery in Kaiser Permanente Northern California hospitals.

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Investigator: Klein, Nicola

Funder: Pfizer Inc.

Beta Hemolytic Streptococcal Infections in a Managed Care Population

Beta Hemolytic Streptococcal Infections in a Managed Care Population

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Investigator: Klein, Nicola

Funder: Pfizer Inc.

HPV Impact Typing Study (HiTS) part II, 2015-2017

This is a follow-up study of of a previous study which evaluated HPV type prevalence in residual cervical specimens from screening. The current study will measure the impact of HPV typing ollowing the introduction of the human papillomavirus vaccine. This study will collect leftover Pap specimens from the clinical lab and sending them to CDC for HPV typing.

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Investigator: Klein, Nicola

Funder: Centers for Disease Control and Prevention

Post-licensure Safety Surveillance Study of Menactra Vaccine When Administered as a 2-dose Schedule to Children 9 Months Through 23 Months of Age (MTA57)

In this project, we will conduct a case-control genome-wide association study to evaluate the human genome of who experienced a febrile seizure (FS) 7-10 days after a measles-containing vaccine, including MMRV and MMR given either alone or concomitantly with varicella vaccine in order to identify genetic risk factors associated with fever and FS.

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Investigator: Klein, Nicola

Funder: Sanofi Pasteur S.A.

Post-Licensure Evaluation of the Long-Term Effectiveness of ZOSTAVAX

This study consists of data collection on patients receiving treatment with Prevnar (13vPnC) as part of their standard medical care.

0

Investigator: Klein, Nicola

Funder: Merck ＆ Company, Inc.

Incidence of Group A Beta Hemolytic Streptococcus Pharyngitis in Children and Group A, B, C and G Invasive Streptococci Disease in Adults Older than 65 years of Age: A Six Year Retrospective Surveillance Study (2004-2009)

This study consists of data collection on patients receiving treatment with Prevnar (13vPnC) as part of their standard medical care.

0

Investigator: Klein, Nicola

Funder: Pfizer Inc.

Evaluation of Waning Protection Against Pertussis Following GSK DTaP Vaccines

California, including the Kaiser Permanente Northern California (KPNC) population area, experienced the largest pertussis outbreak in more than 50 years during 2010-2011.This study will assess the durability of protection against pertussis in children who received 5 doses of DTaP vaccines made by GlaxoSmithKline, a major producer of vaccines in the US and globally. The primary objective is to assess waning protection against pertussis following 5 doses of DTaP among children who received all GSK pertussis vaccines.

0

Investigator: Klein, Nicola

Funder: GlaxoSmithKline PLC

Postlicensure Observational Safety Study of 13 Valent Pneumococcal Conjugate Vaccine Administered in Routine Use to Infants and Toddlers

This study is non-interventional and consists of data collection on patients receiving Pfizer product Prevnar 13.

0

Investigator: Klein, Nicola

Funder: Pfizer Inc.

A Postmarketing Observational Study Estimating the Impact of Prevnar 13 (13vPnC) on Invasive Pneucoccal Disease Caused by Vaccine of Streptococcus pneumoniae After Introduction into Routine Pediatric Use

This study is non-interventional and consists of data collection on patients receiving treatment with the Pfizer product Prevnar (13vPnC) as part of their standard medical care.

0

Investigator: Klein, Nicola

Funder: Pfizer Inc.

Fever in Young Children after Simultaneous Versus Sequential Vaccination with Inactivated Influenza Vaccine (IIV) and PCV13/DTaP Vaccines

The purpose of this project is to provide the Centers for Disease Control and Prevention (CDC), Immunization Safety Office, an as needed mechanism to obtain required services through the issuance of individual task orders in support of vaccine safety monitoring and evaluation that meet public health priorities for CDC. Work performed will be based on the following technical requirements: Clinical Immunization Safety Assessment (CISA) project will be a resource to address clinical vaccine safety issues and provide a public health service to the nation. The project will also contribute to or conduct studies to answer questions about why certain individuals experience adverse events following immunization (AEFI), that are believed to be causally linked to vaccines, and how to prevent them. Results from such studies shall provide evidence to better inform vaccination practices.

0

Investigator: Klein, Nicola

Funder: Centers for Disease Control and Prevention

Autoimmune disease risk following quadrivalent HPV vaccine/Prevention and Public Health Funds (PPHF)

Quadrivalent human papillomavirus vaccine (HPV4) is recommended for males and females 9-26 years of age. Pre-licensure trials for HPV4 did not find an imbalance of autoimmune diseases between study arms, however, associations between rare adverse events and the vaccine in these trials were difficult to detect due to limited sample sizes. Many autoimmune diseases manifest during the young adult years; it is important to assess if there is an increased risk of incident autoimmune disease following HPV4, which is recommended just before adolescence.

0

Investigator: Klein, Nicola

Funder: Centers for Disease Control and Prevention

Effectiveness of a serogroup B meningococcal vaccine against gonorrhea: A retrospective study

Authors: Abara, Winston E;Modaressi, Sharareh;Fireman, Bruce;Klein, Nicola P;Layefsky, Evan;Goddard, Kristin;Bernstein, Kyle T;Kirkcaldy, Robert D;Zerbo, Ousseny

Vaccine. 2024 Sep 10;42(26):126312. Epub 2024-09-10.

PubMed abstract

Effectiveness of the Original Monovalent and Bivalent COVID-19 Vaccines Against COVID-19-Associated Emergency Department and Urgent Care Encounters in Pregnant Persons Who Were Not Immunocompromised: VISION Network, June 2022-August 2023

Authors: Avrich Ciesla, Allison;Klein, Nicola P;Zerbo, Ousseny;Zerbo, Ousseny;et al.

Open Forum Infect Dis. 2024 Sep;11(9):ofae481. Epub 2024-08-28.

PubMed abstract

CLOVER: A Phase 3 Randomized Trial Investigating the Efficacy and Safety of a Detoxified Toxin A/B Vaccine in Adults 50 Years and Older at Increased Risk of Clostridioides difficile Infection

Authors: Donskey, Curtis J;Klein, Nicola P;Kitchin, Nicholas;et al.

Clin Infect Dis. 2024 Aug 24.

PubMed abstract

Trends in Gonorrhea and Chlamydia Testing and Infections Across the COVID-19 Pandemic in Adolescents and Young Adults in an Integrated Health System

Authors: Pelliccione, Alex;Modaressi, Sharareh;Fireman, Bruce;Layefsky, Evan;Klein, Nicola P;Luu, Mitchell N;Zerbo, Ousseny

J Adolesc Health. 2024 Aug 15.

PubMed abstract

Lack of Evidence for Vaccine-Associated Enhanced Disease From COVID-19 Vaccines Among Adults in the Vaccine Safety Datalink

Authors: Boyce, Thomas G;Klein, Nicola P;Belongia, Edward A;et al.

Pharmacoepidemiol Drug Saf. 2024 Aug;33(8):e5863.

PubMed abstract

Immunogenicity and Safety of Extended-Interval 2-Dose Regimens of 9vHPV Vaccine

Authors: Klein, Nicola P;Wiesner, Amy;Bautista, Oliver;Group, Thomas;Kanu, Kevin;Li, Zhongyi Lucy;McCauley, Jennifer;Saxena, Kunal;Tota, Joseph;Luxembourg, Alain;Bonawitz, Rachael

Pediatrics. 2024 Aug 01;154(2).

PubMed abstract

Influenza Vaccine Effectiveness Against Influenza A-Associated Emergency Department, Urgent Care, and Hospitalization Encounters Among US Adults, 2022-2023

Authors: Tenforde, Mark W;Fireman, Bruce;Zerbo, Ousseny;Klein, Nicola P;Klein, Nicola P;et al.

J Infect Dis. 2024 Jul 25;230(1):141-151.

PubMed abstract

Population Attributable Risk of Wheeze in 2-<6-Year-old Children, Following a Respiratory Syncytial Virus Lower Respiratory Tract Infection in The First 2 Years of Life

Authors: Madhi, Shabir A;Klein, Nicola P;Cohen, Rachel A;et al.

Pediatr Infect Dis J. 2024 Jul 01.

PubMed abstract

Ischemic Stroke After Bivalent COVID-19 Vaccination: Self-Controlled Case Series Study

Authors: Xu, Stanley;Sy, Lina S;Hong, Vennis;Holmquist, Kimberly J;Qian, Lei;Farrington, Paddy;Bruxvoort, Katia J;Klein, Nicola P;Fireman, Bruce;Han, Bing;Lewin, Bruno J

JMIR Public Health Surveill. 2024 Jun 25;10:e53807. Epub 2024-06-25.

PubMed abstract

Coronavirus Disease 2019 (COVID-19) Vaccination and Stillbirth in the Vaccine Safety Datalink

Authors: Denoble, Anna E;Klein, Nicola P;Lipkind, Heather S;et al.

Obstet Gynecol. 2024 Jun 06.

PubMed abstract

COVID-19 Vaccination Coverage and Factors Associated With Vaccine Uptake Among People With HIV

Authors: Hechter, Rulin C;Klein, Nicola P;Tseng, Hung Fu;et al.

JAMA Netw Open. 2024 Jun 03;7(6):e2415220. Epub 2024-06-03.

PubMed abstract

Influenza vaccination accuracy among adults: Self-report compared with electronic health record data

Authors: Daley, Matthew F;Klein, Nicola P;Singleton, James A;et al.

Vaccine. 2024 Apr 19;42(11):2740-2746. Epub 2024-03-25.

PubMed abstract

Overview of U.S. COVID-19 vaccine safety surveillance systems

Authors: Gee, Julianne;Klein, Nicola P;Anderson, Steven;et al.

Vaccine. 2024 Apr 16.

PubMed abstract

Interim Effectiveness of Updated 2023-2024 (Monovalent XBB.1.5) COVID-19 Vaccines Against COVID-19-Associated Hospitalization Among Adults Aged ≥18 Years with Immunocompromising Conditions – VISION Network, September 2023-February 2024

Authors: Link-Gelles, Ruth;Klein, Nicola P;Zerbo, Ousseny;Fireman, Bruce;Payne, Amanda B;et al.

MMWR Morb Mortal Wkly Rep. 2024 Mar 28;73(12):271-276. Epub 2024-03-28.

PubMed abstract

A Phase Three Study of the Safety and Immunogenicity of a Four-dose Series of 20-valent Pneumococcal Conjugate Vaccine in Healthy Infants

Authors: Senders, Shelly;Watson, Wendy;et al.

Pediatr Infect Dis J. 2024 Mar 26.

PubMed abstract

Vaccine Effectiveness Against Pediatric Influenza-A-Associated Urgent Care, Emergency Department, and Hospital Encounters During the 2022-2023 Season, VISION Network

Authors: Adams, Katherine;Klein, Nicola P;Fireman, Bruce;Zerbo, Ousseny;Tenforde, Mark W;et al.

Clin Infect Dis. 2024 Mar 20;78(3):746-755.

PubMed abstract

Risk of COVID-19 Hospitalization and Protection Associated With mRNA Vaccination Among US Adults With Psychiatric Disorders

Authors: Levy, Matthew E;Klein, Nicola P;Ball, Sarah W;et al.

Influenza Other Respir Viruses. 2024 Mar;18(3):e13269.

PubMed abstract

Interim Estimates of 2023-24 Seasonal Influenza Vaccine Effectiveness – United States

Authors: Frutos, Aaron M;Klein, Nicola P;CDC Influenza Vaccine Effectiveness Collaborators,;et al.

MMWR Morb Mortal Wkly Rep. 2024 Feb 29;73(8):168-174. Epub 2024-02-29.

PubMed abstract

Interim Effectiveness of Updated 2023-2024 (Monovalent XBB.1.5) COVID-19 Vaccines Against COVID-19-Associated Emergency Department and Urgent Care Encounters and Hospitalization Among Immunocompetent Adults Aged ≥18 Years – VISION and IVY Networks, September 2023-January 2024

Authors: DeCuir, Jennifer;Klein, Nicola P;Fireman, Bruce;CDC COVID-19 Vaccine Effectiveness Collaborators,;et al.

MMWR Morb Mortal Wkly Rep. 2024 Feb 29;73(8):180-188. Epub 2024-02-29.

PubMed abstract

Effectiveness of Recombinant Zoster Vaccine Against Herpes Zoster in a Real-World Setting

Authors: Zerbo, Ousseny;Bartlett, Joan;Fireman, Bruce;Lewis, Ned;Goddard, Kristin;Dooling, Kathleen;Duffy, Jonathan;Glanz, Jason;Naleway, Allison;Donahue, James G;Klein, Nicola P

Ann Intern Med. 2024 Feb;177(2):189-195. Epub 2024-01-09.

PubMed abstract

Recombinant or Standard-Dose Influenza Vaccine in Adults under 65 Years of Age

Authors: Hsiao, Amber;Yee, Arnold;Fireman, Bruce;Hansen, John;Lewis, Ned;Klein, Nicola P

N Engl J Med. 2023 Dec 14;389(24):2245-2255.

PubMed abstract

Impact of accounting for correlation between COVID-19 and influenza vaccination in a COVID-19 vaccine effectiveness evaluation using a test-negative design

Authors: Payne, Amanda B;Klein, Nicola P;VISION Network,;et al.

Vaccine. 2023 Dec 12;41(51):7581-7586. Epub 2023-11-23.

PubMed abstract

Influenza vaccine effectiveness against influenza-A-associated emergency department, urgent care, and hospitalization encounters among U.S. adults, 2022-2023

Authors: Tenforde, Mark W;Fireman, Bruce;Zerbo, Ousseny;Klein, Nicola P;Klein, Nicola P;et al.

J Infect Dis. 2023 Dec 02.

PubMed abstract

Effectiveness of the live zoster vaccine during the 10 years following vaccination: real world cohort study using electronic health records

Authors: Klein, Nicola P;Bartlett, Joan;Fireman, Bruce;Marks, Morgan A;Hansen, John;Lewis, Edwin;Aukes, Laurie;Saddier, Patricia

BMJ. 2023 Nov 08;383:e076321. Epub 2023-11-08.

PubMed abstract

Effectiveness of COVID-19 vaccination during pregnancy by circulating viral variant

Authors: Zerbo, Ousseny;Ray, G Thomas;Fireman, Bruce;Layefsky, Evan;Goddard, Kristin;Ross, Pat;Greenberg, Mara;Klein, Nicola P

AJOG Glob Rep. 2023 Nov;3(4):100264. Epub 2023-08-25.

PubMed abstract

Effectiveness of the Original Monovalent Coronavirus Disease 2019 Vaccines in Preventing Emergency Department or Urgent Care Encounters and Hospitalizations Among Adults With Disabilities: VISION Network, June 2021-September 2022

Authors: Patel, Palak;Klein, Nicola P;Tenforde, Mark W;et al.

Open Forum Infect Dis. 2023 Nov;10(11):ofad474. Epub 2023-09-29.

PubMed abstract

Simultaneous administration of mRNA COVID-19 bivalent booster and influenza vaccines

Authors: Kenigsberg, Tat'Yana A;Lewis, Ned;Weintraub, Eric S;et al.

Vaccine. 2023 Sep 07;41(39):5678-5682. Epub 2023-08-19.

PubMed abstract

Influenza Vaccination Among Pregnant People Before and During the Coronavirus Disease 2019 (COVID-19) Pandemic

Authors: Irving, Stephanie A;Kharbanda, Elyse;Klein, Nicola P;Naleway, Allison L;et al.

Obstet Gynecol. 2023 Sep 01;142(3):636-639. Epub 2023-08-03.

PubMed abstract

Clinical epidemiology and risk factors for critical outcomes among vaccinated and unvaccinated adults hospitalized with COVID-19-VISION Network, 10 States, June 2021-March 2023

Authors: Griggs, Eric P;McEvoy, Charlene;Konatham, Deepika;Hansen, John;Tenforde, Mark W;et al.

Clin Infect Dis. 2023 Aug 26.

PubMed abstract

Effectiveness of COVID-19 vaccines at preventing emergency department or urgent care encounters and hospitalizations among immunocompromised adults: An observational study of real-world data across 10 US states from August-December 2021

Authors: Embi, Peter J;Dunne, Margaret M;Stenehjem, Edward;Weber, Zachary A;Naleway, Allison L;et al.

Vaccine. 2023 Aug 23;41(37):5424-5434. Epub 2023-05-22.

PubMed abstract

Effectiveness of Monovalent and Bivalent mRNA Vaccines in Preventing COVID-19-Associated Emergency Department and Urgent Care Encounters Among Children Aged 6 Months-5 Years – VISION Network, United States, July 2022-June 2023

Authors: Link-Gelles, Ruth;Rowley, Elizabeth A K;Irving, Stephanie A;Weber, Zachary A;Fleming-Dutra, Katherine E;et al.

MMWR Morb Mortal Wkly Rep. 2023 Aug 18;72(33):886-892. Epub 2023-08-18.

PubMed abstract

Individual and neighborhood factors associated with being unvaccinated against COVID-19 among pregnant persons

Authors: Zerbo, Ousseny;Ray, G Thomas;Fireman, Bruce;Layefsky, Evan;Goddard, Kristin;Ross, Pat;Greenberg, Mara;Klein, Nicola P

Hum Vaccin Immunother. 2023 Aug 01;19(2):2256042.

PubMed abstract

Safety of simultaneous vaccination with COVID-19 vaccines in the Vaccine Safety Datalink

Authors: Kenigsberg, Tat'Yana A;Hanson, Kayla E;Klein, Nicola P;Weintraub, Eric S;et al.

Vaccine. 2023 Jul 19;41(32):4658-4665. Epub 2023-06-15.

PubMed abstract

Safety and Tolerability of V114 Pneumococcal Vaccine in Infants: A Phase 3 Study

Authors: Banniettis, Natalie;Oberdorfer, Peninnah;V114-031 (PNEU-LINK) study group,;et al.

Pediatrics. 2023 Jul 01;152(1).

PubMed abstract

Safety of COVID-19 mRNA Vaccination Among Young Children in the Vaccine Safety Datalink

Authors: Goddard, Kristin;Donahue, James G;Lewis, Ned;Hanson, Kayla E;Weintraub, Eric S;Fireman, Bruce;Klein, Nicola P

Pediatrics. 2023 Jul 01;152(1).

PubMed abstract

Estimates of Bivalent mRNA Vaccine Durability in Preventing COVID-19-Associated Hospitalization and Critical Illness Among Adults with and Without Immunocompromising Conditions – VISION Network, September 2022-April 2023

Authors: Link-Gelles, Ruth;Irving, Stephanie A;Rogerson, Colin;Tenforde, Mark W;et al.

Am J Transplant. 2023 Jul;23(7):1062-1076.

PubMed abstract

Evaluation of clinical case definitions for respiratory syncytial virus lower respiratory tract infection in young children

Authors: Englund, Janet A;Jose, Lisa;Dieussaert, Ilse;et al.

J Pediatric Infect Dis Soc. 2023 May 31;12(5):273-281.

PubMed abstract

Estimates of Bivalent mRNA Vaccine Durability in Preventing COVID-19-Associated Hospitalization and Critical Illness Among Adults with and Without Immunocompromising Conditions – VISION Network, September 2022-April 2023

Authors: Link-Gelles, Ruth;Irving, Stephanie A;Rogerson, Colin;Tenforde, Mark W;et al.

MMWR Morb Mortal Wkly Rep. 2023 May 26;72(21):579-588. Epub 2023-05-26.

PubMed abstract

Tdap vaccination during pregnancy and risk of chorioamnionitis and related infant outcomes

Authors: Greenberg, Victoria;Fu Tseng, Hung;DeSilva, Malini B;et al.

Vaccine. 2023 May 22;41(22):3429-3435. Epub 2023-04-26.

PubMed abstract

Effectiveness of BNT162b2 COVID-19 Vaccination in Children and Adolescents

Authors: Klein, Nicola P;Dalton, Alexandra F;Patel, Palak;Link-Gelles, Ruth;et al.

Pediatrics. 2023 May 01;151(5).

PubMed abstract

COVID-19 Booster Vaccination in Early Pregnancy and Surveillance for Spontaneous Abortion

Authors: Kharbanda, Elyse O;Irving, Stephanie A;Vazquez-Benitez, Gabriela;et al.

JAMA Netw Open. 2023 May 01;6(5):e2314350. Epub 2023-05-01.

PubMed abstract

Immunogenicity and Safety of a Third COVID-19 BNT162b2 mRNA Vaccine Dose in 5-11-Year-Olds

Authors: Simões, Eric A F; Klein, Nicola P; C4591007 Clinical Trial Group,; et al.

J Pediatric Infect Dis Soc. 2023 Apr 28;12(4):234-238.

PubMed abstract

Protection of 2 and 3 mRNA Vaccine Doses Against Severe Outcomes Among Adults Hospitalized with COVID-19 – VISION Network, August 2021 – March 2022

Authors: DeSilva, Malini B; Klein, Nicola P; Zerbo, Ousseny; Fireman, Bruce; Gaglani, Manjusha; et al.

J Infect Dis. 2023 Apr 18;227(8):961-969.

PubMed abstract

Evaluation of the effectiveness of maternal immunization against pertussis in Alberta using agent-based modeling: A Canadian immunization research network study

Authors: Hempel, Karsten; McDonald, Wade; Osgood, Nathaniel D; Fisman, David; Halperin, Scott A; Crowcroft, Natasha; Klein, Nicola P; Rohani, Pejman; Doroshenko, Alexander

Vaccine. 2023 Apr 06;41(15):2430-2438. Epub 2023-02-10.

PubMed abstract

Safety of measles, mumps, and rubella vaccine in adolescents and adults in the vaccine safety Datalink

Authors: Hanson, Kayla E; Klein, Nicola P; McLean, Huong Q; et al.

Vaccine X. 2023 Apr;13:100268. Epub 2023-02-04.

PubMed abstract

Early Estimates of Bivalent mRNA Vaccine Effectiveness in Preventing COVID-19-Associated Emergency Department or Urgent Care Encounters and Hospitalizations Among Immunocompetent Adults – VISION Network, Nine States, September-November 2022

Authors: Tenforde, Mark W; Klein, Nicola P; Fireman, Bruce; Zerbo, Ousseny; Link-Gelles, Ruth; et al.

MMWR Morb Mortal Wkly Rep. 2023 Mar 17;71(53):1637-1646. Epub 2023-03-17.

PubMed abstract

COVID-19 Vaccine Safety Surveillance in Early Pregnancy in the United States: Design Factors Affecting the Association Between Vaccine and Spontaneous Abortion

Authors: Vazquez-Benitez, Gabriela; Klein, Nicola P; Kharbanda, Elyse O; et al.

Am J Epidemiol. 2023 Mar 16.

PubMed abstract

Safety of 9-valent human papillomavirus vaccine administered to males and females in routine use

Authors: Hansen, John;Yee, Arnold;Lewis, Ned;Li, Se;Velicer, Christine;Saddier, Patricia;Klein, Nicola P

Vaccine. 2023 Mar 10;41(11):1819-1825. Epub 2022-11-14.

PubMed abstract

Estimation of COVID-19 mRNA Vaccine Effectiveness and COVID-19 Illness and Severity by Vaccination Status During Omicron BA.4 and BA.5 Sublineage Periods

Authors: Link-Gelles, Ruth; Klein, Nicola P; Zerbo, Ousseny; Fireman, Bruce; Tenforde, Mark W; et al.

JAMA Netw Open. 2023 Mar 01;6(3):e232598. Epub 2023-03-01.

PubMed abstract

Maternal SARS-CoV-2 vaccination and infant protection against SARS-CoV-2 during the first six months of life

Authors: Zerbo, Ousseny; Ray, G Thomas; Fireman, Bruce; Layefsky, Evan; Goddard, Kristin; Lewis, Edwin; Ross, Pat; Omer, Saad; Greenberg, Mara; Klein, Nicola P

Nat Commun. 2023 Feb 28;14(1):894. Epub 2023-02-28.

PubMed abstract

Active Post-Licensure Safety Surveillance for Recombinant Zoster Vaccine Using Electronic Health Record Data

Authors: Nelson, Jennifer C; Klein, Nicola P; Jackson, Lisa A; et al.

Am J Epidemiol. 2023 Feb 01;192(2):205-216.

PubMed abstract

Vaccine effectiveness against influenza-associated urgent care, emergency department, and hospital encounters during the 2021-2022 season, VISION Network

Authors: Tenforde, Mark W; Fireman, Bruce; Zerbo, Ousseny; Klein, Nicola P; et al.

J Infect Dis. 2023 Jan 23.

PubMed abstract

A safety study evaluating non-COVID-19 mortality risk following COVID-19 vaccination

Authors: Xu, Stanley; Klein, Nicola P; Fireman, Bruce; Qian, Lei; et al.

Vaccine. 2023 Jan 16;41(3):844-854. Epub 2022-12-20.

PubMed abstract

Characterization of parental intention to vaccinate elementary school aged children in the state of California

Authors: Dudley, Matthew Z; Klein, Nicola P; Salmon, Daniel A; et al.

Vaccine. 2023 Jan 16;41(3):630-635. Epub 2022-12-19.

PubMed abstract

All Older Adults Benefit From Pneumococcal Vaccinations-The Case for Evaluating Vaccine Effectiveness Using All-Cause Pneumonia

Authors: Hsiao, Amber; Klein, Nicola P

JAMA Intern Med. 2023 Jan 01;183(1):48-49.

PubMed abstract

Association Between Aluminum Exposure From Vaccines Before Age 24 Months and Persistent Asthma at Age 24 to 59 Months

Authors: Daley, Matthew F; Klein, Nicola P; DeStefano, Frank; et al.

Acad Pediatr. 2023 Jan-Feb;23(1):37-46. Epub 2022-09-28.

PubMed abstract

COVID-19 vaccination protects children and adolescents

Authors: Irving, Stephanie A; Klein, Nicola P

Lancet Infect Dis. 2023 Jan;23(1):5-6. Epub 2022-09-09.

PubMed abstract

Extended surveillance to assess safety of 9-valent human papillomavirus vaccine

Authors: Sundaram, Maria E; Klein, Nicola P; Donahue, James G; et al.

Hum Vaccin Immunother. 2022 Dec 30;18(7):2159215. Epub 2022-12-28.

PubMed abstract

Early Estimates of Bivalent mRNA Vaccine Effectiveness in Preventing COVID-19-Associated Emergency Department or Urgent Care Encounters and Hospitalizations Among Immunocompetent Adults – VISION Network, Nine States, September-November 2022

Authors: Tenforde, Mark W; Klein, Nicola P; Fireman, Bruce; Zerbo, Ousseny; Link-Gelles, Ruth; et al.

MMWR Morb Mortal Wkly Rep. 2022 Dec 30;71(5152):1616-1624. Epub 2022-12-30.

PubMed abstract

Incidence of Myocarditis/Pericarditis Following mRNA COVID-19 Vaccination Among Children and Younger Adults in the United States

Authors: Goddard, Kristin; Hanson, Kayla E; Lewis, Ned; Weintraub, Eric; Fireman, Bruce; Klein, Nicola P

Ann Intern Med. 2022 Dec;175(12):1169-1771. Epub 2022-10-04.

PubMed abstract

Prescribing for different antibiotic classes across age groups in the Kaiser Permanente Northern California population in association with influenza incidence, 2010-2018

Authors: Goldstein, Edward; Fireman, Bruce H; Klein, Nicola P; Lipsitch, Marc; Ray, G Thomas

Epidemiol Infect. 2022 Oct 26;150:e180. Epub 2022-10-26.

PubMed abstract

Effectiveness of COVID-19 mRNA Vaccines Against COVID-19-Associated Hospitalizations Among Immunocompromised Adults During SARS-CoV-2 Omicron Predominance – VISION Network, 10 States, December 2021-August 2022

Authors: Britton, Amadea; Klein, Nicola P; Zerbo, Ousseny; Fireman, Bruce; Tenforde, Mark W; et al.

MMWR Morb Mortal Wkly Rep. 2022 Oct 21;71(42):1335-1342. Epub 2022-10-21.

PubMed abstract

Maternal SARS-CoV-2 Vaccination and Infant Protection Against SARS-CoV-2 During the First 6 Months of Life

Authors: Zerbo, Ousseny; Ray, G Thomas; Fireman, Bruce; Layefsky, Evan; Goddard, Kristin; Lewis, Edwin; Ross, Pat; Omer, Saad; Greenberg, Mara; Klein, Nicola

Res Sq. 2022 Oct 18.

PubMed abstract

Waning of vaccine effectiveness against moderate and severe covid-19 among adults in the US from the VISION network: test negative, case-control study

Authors: Ferdinands, Jill M; Klein, Nicola P; Zerbo, Ousseny; Fireman, Bruce; et al.

BMJ. 2022 10 03;379:e072141. Epub 2022-10-03.

PubMed abstract

Estimation of COVID-19 mRNA Vaccine Effectiveness Against Medically Attended COVID-19 in Pregnancy During Periods of Delta and Omicron Variant Predominance in the United States

Authors: Schrag, Stephanie J; Zerbo, Ousseny; Klein, Nicola P; Fireman, Bruce; Naleway, Allison L; et al.

JAMA Netw Open. 2022 09 01;5(9):e2233273. Epub 2022-09-01.

PubMed abstract

Incidence of respiratory syncytial virus lower respiratory tract infections during the first 2 years of life: A prospective study across diverse global settings

Authors: Langley, Joanne M; Klein, Nicola P; Cohen, Rachel A; et al.

J Infect Dis. 2022 Aug 26;226(3):374-385.

PubMed abstract

Risk of myocarditis and pericarditis following BNT162b2 and mRNA-1273 COVID-19 vaccination

Authors: Goddard, Kristin; Fireman, Bruce; Zerbo, Ousseny; Klein, Nicola P; et al.

Vaccine. 2022 Aug 19;40(35):5153-5159. Epub 2022-07-12.

PubMed abstract

Safety of COVID-19 Vaccination in US Children Ages 5-11 Years

Authors: Hause, Anne M; Klein, Nicola P; Fireman, Bruce; Zerbo, Ousseny; Shimabukuro, Tom T; et al.

Pediatrics. 2022 08 01;150(2).

PubMed abstract

Adults hospitalized with breakthrough COVID-19 have lower mortality than matched unvaccinated adults

Authors: Myers, Laura C; Kipnis, Patricia; Greene, John; Lawson, Brian; Escobar, Gabriel J; Fireman, Bruce H; Klein, Nicola P; Liu, Vincent X

J Intern Med. 2022 08;292(2):377-384. Epub 2022-05-17.

PubMed abstract

Effectiveness of 2, 3, and 4 COVID-19 mRNA Vaccine Doses Among Immunocompetent Adults During Periods when SARS-CoV-2 Omicron BA.1 and BA.2/BA.2.12.1 Sublineages Predominated – VISION Network, 10 States, December 2021-June 2022

Authors: Link-Gelles, Ruth; Klein, Nicola P; Fireman, Bruce; Zerbo, Ousseny; Tenforde, Mark W; et al.

MMWR Morb Mortal Wkly Rep. 2022 Jul 22;71(29):931-939. Epub 2022-07-22.

PubMed abstract

Safety of Live-Attenuated Vaccines in Children Exposed to Biologic Response Modifiers in Utero

Authors: Zerbo, Ousseny; Klein, Nicola P; et al.

Pediatrics. 2022 07 01;150(1).

PubMed abstract

Lessons from a mature acellular pertussis vaccination program and strategies to overcome suboptimal vaccine effectiveness

Authors: Zerbo, Ousseny; Fireman, Bruce; Klein, Nicola P

Expert Rev Vaccines. 2022 07;21(7):899-907. Epub 2021-10-08.

PubMed abstract

Influenza Vaccination Among Pregnant Women: Self-report Compared With Vaccination Data From Electronic Health Records, 2018-2020 Influenza Seasons

Authors: Daley, Matthew F; Klein, Nicola P; Singleton, James A; et al.

Public Health Rep. 2022 Jun 08:333549221099932.

PubMed abstract

Myocarditis or Pericarditis Following mRNA COVID-19 Vaccination

Authors: Weintraub, Eric S; Oster, Matthew E; Klein, Nicola P

JAMA Netw Open. 2022 Jun 01;5(6):e2218512. Epub 2022-06-01.

PubMed abstract

Effect of Electronic and Mail Outreach From Primary Care Physicians for COVID-19 Vaccination of Black and Latino Older Adults: A Randomized Clinical Trial

Authors: Lieu, Tracy A; Klein, Nicola P; Quesenberry, Charles P; Chen, Yi-Fen Irene; et al.

JAMA Netw Open. 2022 Jun 01;5(6):e2217004. Epub 2022-06-01.

PubMed abstract

Safety and Efficacy of a Third Dose of BNT162b2 Covid-19 Vaccine

Authors: Moreira, Edson D; Klein, Nicola P; C4591031 Clinical Trial Group,; et al.

N Engl J Med. 2022 05 19;386(20):1910-1921. Epub 2022-03-23.

PubMed abstract

Safety of measles and pertussis-containing vaccines in children with autism spectrum disorders

Authors: Zerbo, Ousseny; Fireman, Bruce; Klein, Nicola P; et al.

Vaccine. 2022 04 20;40(18):2568-2573. Epub 2022-03-18.

PubMed abstract

Incidence of Guillain-Barré Syndrome After COVID-19 Vaccination in the Vaccine Safety Datalink

Authors: Hanson, Kayla E; Fireman, Bruce; Klein, Nicola P; et al.

JAMA Netw Open. 2022 Apr 01;5(4):e228879. Epub 2022-04-01.

PubMed abstract

Changes in Cervical Cytology Results and Human Papillomavirus Types Among Persons Screened for Cervical Cancer, 2007 and 2015-2017

Authors: Lewis, Rayleen M; Klein, Nicola P; Markowitz, Lauri E; et al.

J Low Genit Tract Dis. 2022 Apr 01;26(2):135-139.

PubMed abstract

Effectiveness of Homologous and Heterologous COVID-19 Booster Doses Following 1 Ad.26.COV2.S (Janssen [Johnson & Johnson]) Vaccine Dose Against COVID-19-Associated Emergency Department and Urgent Care Encounters and Hospitalizations Among Adults – VISION Network, 10 States, December 2021-March 2022

Authors: Natarajan, Karthik; Klein, Nicola P; Fireman, Bruce; Zerbo, Ousseny; Dixon, Brian E; et al.

MMWR Morb Mortal Wkly Rep. 2022 Apr 01;71(13):495-502. Epub 2022-04-01.

PubMed abstract

Added Benefit of Covid-19 Vaccination after Previous Infection

Authors: Klein, Nicola P

N Engl J Med. 2022 03 31;386(13):1278-1279.

PubMed abstract

Effectiveness of COVID-19 Pfizer-BioNTech BNT162b2 mRNA Vaccination in Preventing COVID-19-Associated Emergency Department and Urgent Care Encounters and Hospitalizations Among Nonimmunocompromised Children and Adolescents Aged 5-17 Years – VISION Network, 10 States, April 2021-January 2022

Authors: Klein, Nicola P; Fireman, Bruce; Zerbo, Ousseny; Verani, Jennifer R; et al.

MMWR Morb Mortal Wkly Rep. 2022 Mar 04;71(9):352-358. Epub 2022-03-04.

PubMed abstract

Incidence and Estimated Vaccine Effectiveness Against Hospitalizations for All-Cause Pneumonia Among Older US Adults Who Were Vaccinated and Not Vaccinated With 13-Valent Pneumococcal Conjugate Vaccine

Authors: Hsiao, Amber; Hansen, John; Timbol, Julius; Lewis, Ned; Isturiz, Raul; Alexander-Parrish, Ronika; McLaughlin, John M; Gessner, Bradford D; Klein, Nicola P

JAMA Netw Open. 2022 03 01;5(3):e221111. Epub 2022-03-01.

PubMed abstract

Antibiotic prescribing across age groups in the Kaiser Permanente Northern California population in association with different diagnoses, and with influenza incidence, 2010-2018

Authors: Goldstein, Edward; Fireman, Bruce H; Klein, Nicola P; Lipsitch, Marc; Ray, G Thomas

Epidemiol Infect. 2022 Feb 24;150:e85. Epub 2022-02-24.

PubMed abstract

A decade of data: Adolescent vaccination in the vaccine safety datalink, 2007 through 2016

Authors: Irving, Stephanie A; Klein, Nicola P; Stokley, Shannon; et al.

Vaccine. 2022 02 23;40(9):1246-1252. Epub 2022-02-04.

PubMed abstract

Waning 2-Dose and 3-Dose Effectiveness of mRNA Vaccines Against COVID-19-Associated Emergency Department and Urgent Care Encounters and Hospitalizations Among Adults During Periods of Delta and Omicron Variant Predominance – VISION Network, 10 States, August 2021-January 2022

Authors: Ferdinands, Jill M; Klein, Nicola P; Zerbo, Ousseny; Fireman, Bruce; et al.

MMWR Morb Mortal Wkly Rep. 2022 Feb 18;71(7):255-263. Epub 2022-02-18.

PubMed abstract

Evaluation of Trends in Homeschooling Rates After Elimination of Nonmedical Exemptions to Childhood Immunizations in California, 2012-2020

Authors: Patel, Kavin M; McFadden, SarahAnn M; Mohanty, Salini; Joyce, Caroline M; Delamater, Paul L; Klein, Nicola P; Salmon, Daniel A; Omer, Saad B; Buttenheim, Alison M

JAMA Netw Open. 2022 02 01;5(2):e2146467. Epub 2022-02-01.

PubMed abstract

Safety of recombinant quadrivalent influenza vaccine compared to inactivated influenza vaccine in Chinese adults: An observational study

Authors: Hsiao, Amber; Hansen, John; Nunley, Karen Valdez; Lewis, Ned; Selmani, Alex; Inamdar, Ajinkya; Mallett-Moore, Tamala; Izikson, Ruvim; Rudin, Deborah; Klein, Nicola P

Vaccine. 2022 01 31;40(5):774-779. Epub 2022-01-06.

PubMed abstract

Effectiveness of a Third Dose of mRNA Vaccines Against COVID-19-Associated Emergency Department and Urgent Care Encounters and Hospitalizations Among Adults During Periods of Delta and Omicron Variant Predominance – VISION Network, 10 States, August 2021-January 2022

Authors: Thompson, Mark G; Klein, Nicola P; Fireman, Bruce; Zerbo, Ousseny; Ong, Toan C; et al.

MMWR Morb Mortal Wkly Rep. 2022 Jan 21;71(4):139-145. Epub 2022-01-21.

PubMed abstract

Effectiveness of two-dose vaccination with mRNA COVID-19 vaccines against COVID-19-associated hospitalizations among immunocompromised adults-Nine States, January-September 2021

Authors: Embi, Peter J; Klein, Nicola P; Fireman, Bruce; Zerbo, Ousseny; DeSilva, Malini B; et al.

Am J Transplant. 2022 01;22(1):306-314.

PubMed abstract

Association of the COVID-19 Pandemic With Routine Childhood Vaccination Rates and Proportion Up to Date With Vaccinations Across 8 US Health Systems in the Vaccine Safety Datalink

Authors: DeSilva, Malini B; Klein, Nicola P; Kharbanda, Elyse O; et al.

JAMA Pediatr. 2022 01 01;176(1):68-77.

PubMed abstract

Population-based assessment of risks for severe COVID-19 disease outcomes

Authors: Zerbo, Ousseny; Lewis, Ned; Fireman, Bruce; Goddard, Kristin; Skarbinski, Jacek; Sejvar, James J; Azziz-Baumgartner, Eduardo; Klein, Nicola P

Influenza Other Respir Viruses. 2022 01;16(1):159-165. Epub 2021-08-25.

PubMed abstract

A multi-country investigation of influenza vaccine coverage in pregnant individuals, 2010-2016

Authors: Irving, Stephanie A; Klein, Nicola P; PREVENT study team,; et al.

Vaccine. 2021 12 20;39(52):7598-7605. Epub 2021-11-19.

PubMed abstract

The Childhood Vaccination Schedule and the Lack of Association With Type 1 Diabetes

Authors: Glanz, Jason M; Klein, Nicola P; DeStefano, Frank; et al.

Pediatrics. 2021 12 01;148(6).

PubMed abstract

Hypotonic-hyporesponsive Episodes After Diphtheria, Tetanus and Acellular Pertussis Vaccination

Authors: Hansen, John; Decker, Michael D; Lewis, Edwin; Fireman, Bruce; Pool, Vitali; Greenberg, David P; Johnson, David R; Black, Steven; Klein, Nicola P

Pediatr Infect Dis J. 2021 12 01;40(12):1122-1126.

PubMed abstract

Laboratory-Confirmed COVID-19 Among Adults Hospitalized with COVID-19-Like Illness with Infection-Induced or mRNA Vaccine-Induced SARS-CoV-2 Immunity – Nine States, January-September 2021

Authors: Bozio, Catherine H; Klein, Nicola P; Fireman, Bruce; Zerbo, Ousseny; Stenehjem, Edward; et al.

MMWR Morb Mortal Wkly Rep. 2021 Nov 05;70(44):1539-1544. Epub 2021-11-05.

PubMed abstract

Effectiveness of 2-Dose Vaccination with mRNA COVID-19 Vaccines Against COVID-19-Associated Hospitalizations Among Immunocompromised Adults – Nine States, January-September 2021

Authors: Embi, Peter J; Klein, Nicola P; Fireman, Bruce; Zerbo, Ousseny; DeSilva, Malini B; et al.

MMWR Morb Mortal Wkly Rep. 2021 Nov 05;70(44):1553-1559. Epub 2021-11-05.

PubMed abstract

COVID-19 Vaccination and Non-COVID-19 Mortality Risk – Seven Integrated Health Care Organizations, United States, December 14, 2020-July 31, 2021

Authors: Xu, Stanley; Klein, Nicola P; Qian, Lei; et al.

MMWR Morb Mortal Wkly Rep. 2021 Oct 29;70(43):1520-1524. Epub 2021-10-29.

PubMed abstract

The Adjuvanted Recombinant Zoster Vaccine in Adults Aged ≥65 Years Previously Vaccinated With a Live-Attenuated Herpes Zoster Vaccine

Authors: Dagnew AF; Klein NP; Hervé C; Kalema G; Di Paolo E; Peterson J; Salaun B; Schuind A

J Infect Dis. 2021 10 13;224(7):1139-1146.

PubMed abstract

Surveillance for Adverse Events After COVID-19 mRNA Vaccination

Authors: Klein, Nicola P; Fireman, Bruce; Zerbo, Ousseny; Weintraub, Eric S; et al.

JAMA. 2021 10 12;326(14):1390-1399.

PubMed abstract

City-wide school-located influenza vaccination: A retrospective cohort study

Authors: Benjamin-Chung, Jade; Klein, Nicola P; Colford, John M; et al.

Vaccine. 2021 10 08;39(42):6302-6307. Epub 2021-09-14.

PubMed abstract

Effectiveness of Covid-19 Vaccines in Ambulatory and Inpatient Care Settings

Authors: Thompson, Mark G; Fireman, Bruce; Zerbo, Ousseny; Klein, Nicola P; et al.

N Engl J Med. 2021 10 07;385(15):1355-1371. Epub 2021-09-08.

PubMed abstract

Safety and Immunogenicity of a 20-valent Pneumococcal Conjugate Vaccine in Healthy Infants in the United States

Authors: Senders, Shelly; Lamberth, Erik; Watson, Wendy; et al.

Pediatr Infect Dis J. 2021 10 01;40(10):944-951.

PubMed abstract

Interim Estimates of COVID-19 Vaccine Effectiveness Against COVID-19-Associated Emergency Department or Urgent Care Clinic Encounters and Hospitalizations Among Adults During SARS-CoV-2 B.1.617.2 (Delta) Variant Predominance – Nine States, June-August 2021

Authors: Grannis, Shaun J; Rowley, Elizabeth A; Ong, Toan C; Stenehjem, Edward; Klein, Nicola P; DeSilva, Malini B; Naleway, Allison L; Natarajan, Karthik; Thompson, Mark G; VISION Network,

MMWR Morb Mortal Wkly Rep. 2021 Sep 17;70(37):1291-1293. Epub 2021-09-17.

PubMed abstract

A phase 3, randomized, double-blind study to evaluate the immunogenicity and safety of 3 lots of 20-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naive adults 18 through 49 years of age

Authors: Klein, Nicola P; Peyrani, Paula; Yacisin, Kari; Caldwell, Nicole; Xu, Xia; Scully, Ingrid L; Scott, Daniel A; Jansen, Kathrin U; Gruber, William C; Watson, Wendy

Vaccine. 2021 09 07;39(38):5428-5435. Epub 2021-07-24.

PubMed abstract

Use of COVID-19 Vaccines After Reports of Adverse Events Among Adult Recipients of Janssen (Johnson & Johnson) and mRNA COVID-19 Vaccines (Pfizer-BioNTech and Moderna): Update from the Advisory Committee on Immunization Practices – United States, July 2021

Authors: Rosenblum, Hannah G; Klein, Nicola P; Oliver, Sara E; et al.

MMWR Morb Mortal Wkly Rep. 2021 Aug 13;70(32):1094-1099. Epub 2021-08-13.

PubMed abstract

COVID-19 Vaccination Coverage Among Insured Persons Aged ≥16 Years, by Race/Ethnicity and Other Selected Characteristics – Eight Integrated Health Care Organizations, United States, December 14, 2020-May 15, 2021

Authors: Pingali, Cassandra; Klein, Nicola P; Fireman, Bruce; Zerbo, Ousseny; Patel, Suchita A; et al.

MMWR Morb Mortal Wkly Rep. 2021 Jul 16;70(28):985-990. Epub 2021-07-16.

PubMed abstract

Safety, Immunogenicity, and Efficacy of the BNT162b2 Covid-19 Vaccine in Adolescents

Authors: Frenck, Robert W; Klein, Nicola P; C4591001 Clinical Trial Group,; et al.

N Engl J Med. 2021 07 15;385(3):239-250. Epub 2021-05-27.

PubMed abstract

School-level perceptions and enforcement of the elimination of nonmedical exemptions to vaccination in California

Authors: Holroyd, Taylor A; Howa, Amanda C; Proveaux, Tina M; Delamater, Paul L; Klein, Nicola P; Buttenheim, Alison M; Limaye, Rupali J; Omer, Saad B; Salmon, Daniel A

Hum Vaccin Immunother. 2021 07 03;17(7):1986-1993. Epub 2021-01-25.

PubMed abstract

Temporal Trends in Undervaccination: A Population-Based Cohort Study

Authors: Daley, Matthew F; Klein, Nicola P; Glanz, Jason M; et al.

Am J Prev Med. 2021 07;61(1):64-72. Epub 2021-04-30.

PubMed abstract

Incidence of pediatric inflammatory bowel disease within the Vaccine Safety Datalink network and evaluation of association with rotavirus vaccination

Authors: Liles, Elizabeth; Klein, Nicola P; Naleway, Allison L; et al.

Vaccine. 2021 06 16;39(27):3614-3620. Epub 2021-05-26.

PubMed abstract

Genetic associations with a fever after measles-containing vaccines

Authors: Klein, Nicola P; Zerbo, Ousseny; Goddard, Kristin; Wang, Weiqi; Fohner, Alison E; Wiesner, Amy; Shokoohi, Vida; Coller, John; Bok, Karin; Gans, Hayley A

Hum Vaccin Immunother. 2021 06 03;17(6):1763-1769. Epub 2020-12-22.

PubMed abstract

Parental vaccine attitudes, beliefs, and practices: initial evidence in California after a vaccine policy change

Authors: Holroyd, Taylor A; Howa, Amanda C; Delamater, Paul L; Klein, Nicola P; Buttenheim, Alison M; Limaye, Rupali J; Proveaux, Tina M; Omer, Saad B; Salmon, Daniel A

Hum Vaccin Immunother. 2021 06 03;17(6):1675-1680. Epub 2020-11-24.

PubMed abstract

Multisystem inflammatory syndrome in children and adults (MIS-C/A): Case definition & guidelines for data collection, analysis, and presentation of immunization safety data

Authors: Vogel, Tiphanie P; Klein, Nicola P; Munoz, Flor M; et al.

Vaccine. 2021 05 21;39(22):3037-3049. Epub 2021-02-25.

PubMed abstract

Association of Inadvertent 9-Valent Human Papillomavirus Vaccine in Pregnancy With Spontaneous Abortion and Adverse Birth Outcomes

Authors: Kharbanda, Elyse O; Klein, Nicola P; Lipkind, Heather S; et al.

JAMA Netw Open. 2021 04 01;4(4):e214340. Epub 2021-04-01.

PubMed abstract

Studying attitudes towards vaccine hesitance and California law SB 277 in online discourse: A dataset and methodology

Authors: DeDominicis, Kali; Buttenheim, Alison M; Howa, Amanda C; Delamater, Paul L; Salmon, Daniel; Klein, Nicola P; Omer, Saad B

Data Brief. 2021 Apr;35:106841. Epub 2021-02-24.

PubMed abstract

Concomitant administration of a liquid formulation of human rotavirus vaccine (porcine circovirus-free) with routine childhood vaccines in infants in the United States: Results from a phase 3, randomized trial

Authors: Abu-Elyazeed, Remon; Klein, Nicola P; Moerman, Leentje; Povey, Michael; Pruitt, Anthony; Senders, Shelly; Silas, Peter; Bi, Dan; Rota-090 Study Group,

Vaccine. 2021 03 05;39(10):1534-1543. Epub 2020-10-17.

PubMed abstract

A Risk Score to Predict Clostridioides difficile Infection

Authors: Aukes, Laurie; Fireman, Bruce; Lewis, Edwin; Timbol, Julius; Hansen, John; Yu, Holly; Cai, Bing; Gonzalez, Elisa; Lawrence, Jody; Klein, Nicola P

Open Forum Infect Dis. 2021 Mar;8(3):ofab052. Epub 2021-02-04.

PubMed abstract

Developing Algorithms for Identifying Major Structural Birth Defects Using Automated Electronic Health Data

Authors: Kharbanda, Elyse O; Klein, Nicola P; Romitti, Paul A; et al.

Pharmacoepidemiol Drug Saf. 2021 02;30(2):266-274. Epub 2020-12-03.

PubMed abstract

Evaluating the Association of Stillbirths After Maternal Vaccination in the Vaccine Safety Datalink

Authors: Panagiotakopoulos, Lakshmi; Klein, Nicola P; Weintraub, Eric S; et al.

Obstet Gynecol. 2020 12;136(6):1086-1094.

PubMed abstract

Shouting at each other into the void: A linguistic network analysis of vaccine hesitance and support in online discourse regarding California law SB277

Authors: DeDominicis, Kali; Buttenheim, Alison M; Howa, Amanda C; Delamater, Paul L; Salmon, Daniel; Omer, Saad B; Klein, Nicola P

Soc Sci Med. 2020 12;266:113216. Epub 2020-08-28.

PubMed abstract

Identification and description of mumps cases in a non-outbreak setting and evaluation of the effectiveness of mumps-containing vaccines over time

Authors: Zerbo O; Modaressi S; Glanternik JR; Goddard K; Ross P; Lewis N; Klein NP

Hum Vaccin Immunother. 2020 12 01;16(12):3098-3102. Epub 2020-05-13.

PubMed abstract

Individual and Neighborhood Factors Associated with Failure to Vaccinate against Influenza during Pregnancy

Authors: Zerbo, Ousseny; Ray, G Thomas; Zhang, Lea; Goddard, Kristin; Fireman, Bruce; Adams, Alyce; Omer, Saad; Kulldorff, Martin; Klein, Nicola P

Am J Epidemiol. 2020 11 02;189(11):1379-1388.

PubMed abstract

SARS-CoV-2 Infection Among Hospitalized Pregnant Women: Reasons for Admission and Pregnancy Characteristics – Eight U.S. Health Care Centers, March 1-May 30, 2020

Authors: Panagiotakopoulos, Lakshmi; Klein, Nicola P; Weintraub, Eric S; et al.

MMWR Morb Mortal Wkly Rep. 2020 Sep 23;69(38):1355-1359. Epub 2020-09-23.

PubMed abstract

Evaluation of a Vaccine-Communication Tool for Physicians

Authors: Glanternik JR; McDonald JC; Yee AH; Howell Ba A; Saba KN; Mellor RG; Fireman B; Klein NP

J Pediatr. 2020 09;224:72-78.e1. Epub 2020-06-06.

PubMed abstract

Overcoming Waning Immunity in Pertussis Vaccines: Workshop of the National Institute of Allergy and Infectious Diseases

Authors: Damron, F Heath; Lu, Kristina; Harvill, Eric T; et al.

J Immunol. 2020 08 15;205(4):877-882.

PubMed abstract

Retrospective study of the use of an influenza disease two-tiered classification system to characterize clinical severity in US children

Authors: Hsiao A; Buck PO; Yee A; Hansen J; Lewis EM; Aukes LL; Yanni E; Bekkat-Berkani R; Schuind A; Klein NP

Hum Vaccin Immunother. 2020 08 02;16(8):1753-1761. Epub 2020-02-20.

PubMed abstract

Sensorineural hearing loss (SNHL) as an adverse event following immunization (AEFI): Case definition & guidelines for data collection, analysis, and presentation of immunization safety data

Authors: Carol Liu YC; Ibekwe T; Kelso JM; Klein NP; Shehu N; Steuerwald W; Aneja S; Dudley MZ; Garry R; Munoz FM; Brighton Collaboration SNHL Working Group

Vaccine. 2020 06 19;38(30):4717-4731. Epub 2020-05-15.

PubMed abstract

Safety of Recombinant Influenza Vaccine Compared to Inactivated Influenza Vaccine in Adults: An Observational Study

Authors: Hansen J; Goddard K; Timbol J; Zhang L; Lewis N; Dunkle L; Izikson R; Klein NP

Open Forum Infect Dis. 2020 Jun;7(6):ofaa179. Epub 2020-05-20.

PubMed abstract

Impact of the 13-Valent Pneumococcal Conjugate Vaccine on Invasive Pneumococcal Disease After Introduction Into Routine Pediatric Use

Authors: Baxter R; Aukes L; Pelton SI; Yee A; Klein NP; Gruber WC; Scott DA; Center KJ

J Pediatric Infect Dis Soc. 2020 May 16.

PubMed abstract

Immunogenicity and Safety of a Measles-Mumps-Rubella Vaccine Administered as a First Dose to Children Aged 12 to 15 Months: A Phase III, Randomized, Noninferiority, Lot-to-Lot Consistency Study

Authors: Klein NP; Henry O; et al.

J Pediatric Infect Dis Soc. 2020 Apr 30;9(2):194-201.

PubMed abstract

Epidemiology and clinical outcomes of hospitalizations for acute respiratory or febrile illness and laboratory-confirmed influenza among pregnant women during six influenza seasons, 2010-2016

Authors: Dawood FS; Klein NP; Fell DB; et al.

J Infect Dis. 2020 04 27;221(10):1703-1712.

PubMed abstract

If Influenza Vaccines Wane Can We Delay Vaccination Without Compromising Coverage?

Authors: Klein NP; Fireman B

Clin Infect Dis. 2020 04 10;70(8):1560-1561.

PubMed abstract

Parental Risk Factors for Fever in their Children 7-10 Days After the First Dose of Measles-Containing Vaccines

Authors: Zerbo O; Modaressi S; Goddard K; Lewis E; Bok K; Gans H; Klein NP

Hum Vaccin Immunother. 2020 04 02;16(4):875-880. Epub 2019-11-08.

PubMed abstract

Depletion of Susceptibles Bias in Analyses of Intra-season Waning of Influenza Vaccine Effectiveness

Authors: Ray GT; Lewis N; Klein NP; Daley MF; Lipsitch M; Fireman B

Clin Infect Dis. 2020 03 17;70(7):1484-1486.

PubMed abstract

Human Papillomavirus Vaccine Effectiveness Against HPV Infection: Evaluation of One, Two, and Three Doses

Authors: Markowitz LE; Klein NP; Unger ER; et al.

J Infect Dis. 2020 03 02;221(6):910-918.

PubMed abstract

Fever After Influenza, Diphtheria-Tetanus-Acellular Pertussis, and Pneumococcal Vaccinations

Authors: Walter EB; Klein NP; Wodi AP; Rountree W; Todd CA; Wiesner A; Duffy J; Marquez PL; Broder KR

Pediatrics. 2020 03;145(3). Epub 2020-02-06.

PubMed abstract

Survey of influenza vaccine knowledge, attitudes, and beliefs among pregnant women in the 2016-17 season

Authors: King JP; Hanson KE; Donahue JG; Glanz JM; Klein NP; Naleway AL; DeStefano F; Weintraub E; Belongia EA

Vaccine. 2020 02 24;38(9):2202-2208. Epub 2020-01-25.

PubMed abstract

Homeschooling parents in California: Attitudes, beliefs and behaviors associated with child’s vaccination status

Authors: Mohanty S; Joyce CM; Delamater PL; Klein NP; Salmon D; Omer SB; Buttenheim AM

Vaccine. 2020 02 18;38(8):1899-1905. Epub 2020-01-22.

PubMed abstract

Vaccine effectiveness of cell-culture relative to egg-based inactivated influenza vaccine during the 2017-18 influenza season

Authors: Klein NP; Fireman B; Goddard K; Zerbo O; Asher J; Zhou J; King J; Lewis N

PLoS One. 2020;15(2):e0229279. Epub 2020-02-26.

PubMed abstract

Chorioamnionitis: Case definition & guidelines for data collection, analysis, and presentation of immunization safety data

Authors: Kachikis A; Klein NP; Brighton Collaboration Chorioamnionitis Working Group; et al.

Vaccine. 2019 12 10;37(52):7610-7622.

PubMed abstract

Near Real-Time Surveillance to Assess the Safety of the 9-Valent Human Papillomavirus Vaccine

Authors: Donahue JG; Klein NP; Belongia EA; et al.

Pediatrics. 2019 12;144(6). Epub 2019-11-18.

PubMed abstract

Assessment of Exemptions From Vaccination in California, 2015 to 2027

Authors: Delamater PL; Buttenheim AM; Klein NP; Mohanty S; Salmon DA; Omer SB

Ann Intern Med. 2019 Nov 05.

PubMed abstract

Uptake and safety of hepatitis A vaccination during pregnancy: A Vaccine Safety Datalink study

Authors: Groom HC; Klein NP; Naleway AL; et al.

Vaccine. 2019 10 16;37(44):6648-6655. Epub 2019-09-20.

PubMed abstract

Inactivated influenza vaccine and spontaneous abortion in the Vaccine Safety Datalink in 2012-13, 2013-14, and 2014-15

Authors: Donahue JG; Klein NP; Belongia EA; et al.

Vaccine. 2019 10 16;37(44):6673-6681. Epub 2019-09-17.

PubMed abstract

Reply to Skowronski, De Serres and Orenstein

Authors: Thompson MG; Jackson ML; Regan A; Katz MA; Kwong JC; Ball SW; Simmonds K; Klein NP; Naleway A

Clin Infect Dis. 2019 08 30;69(6):1085-1086.

PubMed abstract

Long-term effectiveness of zoster vaccine live for postherpetic neuralgia prevention

Authors: Klein NP; Bartlett J; Fireman B; Marks MA; Hansen J; Lewis E; Aukes L; Saddier P

Vaccine. 2019 08 23;37(36):5422-5427. Epub 2019-07-10.

PubMed abstract

Antibody persistence and booster response following MenACWY-CRM vaccination in children as assessed by two different assay methods

Authors: Klein NP; Block SL; Essink B; Barbi S; Smolenov I; Keshavan P

Vaccine. 2019 07 26;37(32):4460-4467. Epub 2019-07-03.

PubMed abstract

The impact of reactogenicity after the first dose of recombinant zoster vaccine upon the physical functioning and quality of life of older adults: an open phase III trial

Authors: Schmader KE; Klein NP; Curran D; et al.

J Glaucoma. 2019 05;28(5):473-480.

PubMed abstract

Associations of Statewide Legislative and Administrative Interventions With Vaccination Status Among Kindergartners in California

Authors: Pingali SC; Delamater PL; Buttenheim AM; Salmon DA; Klein NP; Omer SB

JAMA. 2019 07 02;322(1):49-56.

PubMed abstract

Incidence of Herpes Zoster Among Children: 2003-2014

Authors: Weinmann S; Klein NP; Chun C; et al.

Pediatrics. 2019 07;144(1). Epub 2019-06-10.

PubMed abstract

Acellular Pertussis Vaccine Effectiveness Over Time

Authors: Zerbo O; Bartlett J; Goddard K; Fireman B; Lewis E; Klein NP

Pediatrics. 2019 07;144(1). Epub 2019-06-10.

PubMed abstract

Elimination of Nonmedical Immunization Exemptions in California and School-Entry Vaccine Status

Authors: Delamater PL; Pingali SC; Buttenheim AM; Salmon DA; Klein NP; Omer SB

Pediatrics. 2019 06;143(6). Epub 2019-05-21.

PubMed abstract

Vaccine safety in HIV-infected adults within the Vaccine Safety Datalink Project

Authors: Hechter RC; Qian L; Tartof SY; Sy LS; Klein NP; Weintraub E; Mercado C; Naleway A; McLean HQ; Jacobsen SJ

Vaccine. 2019 May 31;37(25):3296-3302. Epub 2019-05-04.

PubMed abstract

Intra-season Waning of Influenza Vaccine Effectiveness

Authors: Ray GT; Lewis N; Klein NP; Daley MF; Wang SV; Kulldorff M; Fireman B

Clin Infect Dis. 2019 05 02;68(10):1623-1630.

PubMed abstract

Influenza Vaccine Effectiveness in Preventing Influenza-associated Hospitalizations During Pregnancy: A Multi-country Retrospective Test Negative Design Study, 2010-2016

Authors: Thompson MG; Klein NP; PREVENT Workgroup; et al.

Clin Infect Dis. 2019 04 24;68(9):1444-1453.

PubMed abstract

Long term risk of developing type 1 diabetes after HPV vaccination in males and females

Authors: Klein NP; Goddard K; Lewis E; Ross P; Gee J; DeStefano F; Baxter R

Vaccine. 2019 03 28;37(14):1938-1944. Epub 2019-03-01.

PubMed abstract

Safety and Immunogenicity of a Full-Dose Split-Virion Inactivated Quadrivalent Influenza Vaccine in Healthy Children 6 to 35 Months of Age: A Randomized Controlled Clinical Trial

Authors: Robertson CA; Mercer M; Selmani A; Klein NP; Jeanfreau R; Greenberg DP

Pediatr Infect Dis J. 2019 03;38(3):323-328.

PubMed abstract

Exploring California’s new law eliminating personal belief exemptions to childhood vaccines and vaccine decision-making among homeschooling mothers in California

Authors: McDonald P; Limaye RJ; Omer SB; Buttenheim AM; Mohanty S; Klein NP; Salmon DA

Value Health. 2019 06;22(6):648-655. Epub 2019-05-17.

PubMed abstract

Estimating Vaccine Effectiveness Against Hospitalized Influenza During Pregnancy: Multicountry Protocol for a Retrospective Cohort Study

Authors: Naleway AL; Klein NP; Thompson MG; et al.

JMIR Res Protoc. 2019 Jan 21;8(1):e11333. Epub 2019-01-21.

PubMed abstract

Similar relative risks of seizures following measles containing vaccination in children born preterm compared to full-term without previous seizures or seizure-related disorders

Authors: McClure DL; Jacobsen SJ; Klein NP; Naleway AL; Kharbanda EO; Glanz JM; Jackson LA; Weintraub ES; McLean HQ

Vaccine. 2019 01 03;37(1):76-79. Epub 2018-11-23.

PubMed abstract

Impact of an electronic medical record reminder on hepatitis B vaccine initiation and completion rates among insured adults with diabetes mellitus

Authors: Hechter RC; Klein NP; Tseng HF; et al.

Vaccine. 2019 01 03;37(1):195-201. Epub 2018-06-27.

PubMed abstract

Evaluation of two frailty indices, with practical application in a vaccine clinical trial

Authors: Curran D; Andrew MK; Levin MJ; Turriani E; Matthews S; Fogarty C; Klein NP; Grupping K; Oostvogels L; Schmader KE

Hum Vaccin Immunother. 2019;15(12):2960-2968. Epub 2019-06-21.

PubMed abstract

Immunogenicity and safety following primary and booster vaccination with a hexavalent diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus and Haemophilus influenzae type b vaccine: a randomized trial in the United States

Authors: Klein NP; Abu-Elyazeed R; Cheuvart B; Janssens W; Mesaros N

Hum Vaccin Immunother. 2019;15(4):809-821. Epub 2019-01-04.

PubMed abstract

Coadministration of 13-valent pneumococcal conjugate and quadrivalent inactivated influenza vaccines in adults previously immunized with polysaccharide pneumococcal vaccine 23: a randomized clinical trial

Authors: Thompson AR; Klein NP; Schmöele-Thoma B; et al.

Hum Vaccin Immunother. 2019;15(2):444-451. Epub 2018-10-25.

PubMed abstract

Immunogenicity and safety of the Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine co-administered with human rotavirus, hepatitis A and 13-valent pneumococcal conjugate vaccines: results from a phase III, randomized, multicenter study in infants

Authors: Klein NP; Abu-Elyazeed R; Baine Y; Cheuvart B; Silerova M; Mesaros N

Hum Vaccin Immunother. 2019;15(2):327-338. Epub 2018-10-05.

PubMed abstract

Comment on “The impact of past vaccination coverage and immunity on pertussis resurgence”

Authors: Winter K; Klein NP; Ackley S; Cherry JD

Science. 2019 04 26;364(6438):341-342.

PubMed abstract

Respiratory Syncytial Virus Hospitalization during Pregnancy in Four High-income Countries, 2010-2016

Authors: Regan AK; Klein NP; PREVENT Group; et al.

Clin Infect Dis. 2018 11 28;67(12):1915-1918.

PubMed abstract

A framework for research on vaccine effectiveness

Authors: Crowcroft NS; Klein NP

Vaccine. 2018 11 19;36(48):7286-7293. Epub 2018-10-26.

PubMed abstract

Uptake and safety of Hepatitis B vaccination during pregnancy: A Vaccine Safety Datalink study

Authors: Groom HC; Klein NP; Naleway AL; et al.

Vaccine. 2018 10 01;36(41):6111-6116. Epub 2018-09-05.

PubMed abstract

Factors Affecting Vaccination in Children and Their Siblings After Autism Spectrum Disorder Diagnosis-Reply

Authors: Zerbo O; Klein NP

JAMA Pediatr. 2018 10 01;172(10):985-986.

PubMed abstract

Assessing Potential Confounding and Misclassification Bias When Studying the Safety of the Childhood Immunization Schedule

Authors: Daley MF; Shoup JA; Newcomer SR; Jackson ML; Groom HC; Jacobsen SJ; McLean HQ; Klein NP; Weintraub ES; McNeil MM; Glanz JM

Acad Pediatr. 2018 Sep - Oct;18(7):754-762. Epub 2018-03-28.

PubMed abstract

Safety of repeated doses of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine in adults and adolescents

Authors: Jackson ML; Yu O; Nelson JC; Nordin JD; Tartof SY; Klein NP; Donahue JG; Irving SA; Glanz JM; McNeil MM; Jackson LA

Pharmacoepidemiol Drug Saf. 2018 08;27(8):921-925. Epub 2018-06-03.

PubMed abstract

Risk of Spontaneous Abortion After Inadvertent Human Papillomavirus Vaccination in Pregnancy

Authors: Kharbanda EO; Klein NP; Nordin JD; et al.

Obstet Gynecol. 2018 07;132(1):35-44.

PubMed abstract

Pneumococcal Conjugate Vaccine Safety in Elderly Adults

Authors: Tseng HF; Klein NP; Jacobsen SJ; et al.

Open Forum Infect Dis. 2018 Jun;5(6):ofy100. Epub 2018-05-02.

PubMed abstract

Birth outcomes following immunization of pregnant women with pandemic H1N1 influenza vaccine 2009-2010

Authors: Eaton A; Lewis N; Fireman B; Hansen J; Baxter R; Gee J; Klein NP

Vaccine. 2018 05 03;36(19):2733-2739. Epub 2017-09-13.

PubMed abstract

Vaccination Patterns in Children After Autism Spectrum Disorder Diagnosis and in Their Younger Siblings

Authors: Zerbo O; Fireman BH; Klein NP; et al.

JAMA Pediatr. 2018 05 01;172(5):469-475.

PubMed abstract

Live Attenuated Influenza Vaccination Prior To Age 3 Years and Subsequent Development of Asthma: A 14-Year Follow-Up Study

Authors: Baxter RP; Lewis N; Fireman B; Hansen J; Klein NP; Ortiz JR

Pediatr Infect Dis J. 2018 05;37(5):383-386.

PubMed abstract

Immunogenicity and safety of the quadrivalent meningococcal ACWY-tetanus toxoid conjugate vaccine (MenACWY-TT) in splenectomized or hyposplenic children and adolescents: Results of a phase III, open, non-randomized study

Authors: Klein NP; Habanec T; Kosina P; Shah NR; Kolhe D; Miller JM; Hezareh M; Van der Wielen M

Vaccine. 2018 04 19;36(17):2356-2363. Epub 2018-03-22.

PubMed abstract

Post-licensure safety surveillance study of routine use of quadrivalent meningococcal diphtheria toxoid conjugate vaccine (MenACWY-D) in infants and children

Authors: Hansen J; Zhang L; Eaton A; Baxter R; Robertson CA; Decker MD; Greenberg DP; Bassily E; Klein NP

Vaccine. 2018 04 12;36(16):2133-2138. Epub 2018-03-14.

PubMed abstract

Meningococcal conjugate vaccine safety surveillance in the Vaccine Safety Datalink using a tree-temporal scan data mining method

Authors: Li R; Weintraub E; McNeil MM; Kulldorff M; Lewis EM; Nelson J; Xu S; Qian L; Klein NP; Destefano F

Pharmacoepidemiol Drug Saf. 2018 04;27(4):391-397. Epub 2018-02-15.

PubMed abstract

Infant Hospitalizations and Mortality After Maternal Vaccination

Authors: Sukumaran L; Klein NP; Weintraub ES; et al.

Pediatrics. 2018 03;141(3). Epub 2018-02-20.

PubMed abstract

Postlicensure Safety Surveillance of Congenital Anomaly and Miscarriage Among Pregnancies Exposed to Quadrivalent Human Papillomavirus Vaccine

Authors: Sy LS; Klein NP; Jacobsen SJ; et al.

Hum Vaccin Immunother. 2018 02 01;14(2):412-419. Epub 2017-12-14.

PubMed abstract

Long-Term Effectiveness of the Live Zoster Vaccine in Preventing Shingles: A Cohort Study

Authors: Baxter R; Bartlett J; Fireman B; Marks M; Hansen J; Lewis E; Aukes L; Chen Y; Klein NP; Saddier P

Am J Epidemiol. 2018 01 01;187(1):161-169.

PubMed abstract

The safety of live attenuated influenza vaccine in children and adolescents 2 through 17years of age: A Vaccine Safety Datalink study

Authors: Daley MF; Klein NP; Weintraub E; et al.

Pharmacoepidemiol Drug Saf. 2018 01;27(1):59-68. Epub 2017-11-17.

PubMed abstract

Rates and risk factors associated with hospitalization for pneumonia with ICU admission among adults

Authors: Storms AD; Chen J; Jackson LA; Nordin JD; Naleway AL; Glanz JM; Jacobsen SJ; Weintraub ES; Klein NP; Gargiullo PM; Fry AM

BMC Pulm Med. 2017 Dec 16;17(1):208. Epub 2017-12-16.

PubMed abstract

Congenital microcephaly: Case definition & guidelines for data collection, analysis, and presentation of safety data after maternal immunisation

Authors: DeSilva M; Oleske JM; Brighton Collaboration Congenital Microcephaly Working Group; et al.

Vaccine. 2017 12 04;35(48 Pt A):6472-6482.

PubMed abstract

Respiratory distress in the neonate: Case definition & guidelines for data collection, analysis, and presentation of maternal immunization safety data

Authors: Sweet LR; Klein NP; Brighton Collaboration Respiratory Distress in the Neonate Working Group; et al.

Vaccine. 2017 12 04;35(48 Pt A):6506-6517.

PubMed abstract

Patterns of childhood immunization and all-cause mortality

Authors: McCarthy NL; Sukumaran L; Newcomer S; Glanz J; Daley MF; McClure D; Klein NP; Irving S; Jackson ML; Lewin B; Weintraub E

Vaccine. 2017 12 04;35(48 Pt B):6643-6648. Epub 2017-10-20.

PubMed abstract

Use of acellular pertussis vaccines in the United States: can we do better?

Authors: Klein NP; Zerbo O

Expert Rev Vaccines. 2017 12;16(12):1175-1179. Epub 2017-10-20.

PubMed abstract

Risk of venous thromboembolism following influenza vaccination in adults aged 50years and older in the Vaccine Safety Datalink

Authors: Vickers ER; McClure DL; Naleway AL; Jacobsen SJ; Klein NP; Glanz JM; Weintraub ES; Belongia EA

Vaccine. 2017 Oct 13;35(43):5872-5877. Epub 2017-09-06.

PubMed abstract

Association of spontaneous abortion with receipt of inactivated influenza vaccine containing H1N1pdm09 in 2010-11 and 2011-12

Authors: Donahue JG; Klein NP; Belongia EA; et al.

Vaccine. 2017 Sep 25;35(40):5314-5322.

PubMed abstract

Post-licensure safety surveillance study of routine use of quadrivalent meningococcal diphtheria toxoid conjugate vaccine

Authors: Hansen J; Zhang L; Klein NP; Robertson CA; Decker MD; Greenberg DP; Bassily E; Baxter R

Vaccine. 2017 Sep 20.

PubMed abstract

Maternal and Infant Outcomes After Human Papillomavirus Vaccination in the Periconceptional Period or During Pregnancy

Authors: Lipkind HS; Klein NP; Kharbanda EO; et al.

Obstet Gynecol. 2017 Sep;130(3):599-608.

PubMed abstract

Febrile Seizure Risk after Vaccination in Children One to Five Months of Age

Authors: Duffy J; Hambidge SJ; Jackson LA; Kharbanda EO; Klein NP; Naleway A; Omer SB; Weintraub E; Vaccine Safety Datalink

Pediatr Neurol. 2017 Aug 23.

PubMed abstract

First Trimester Influenza Vaccination and Risks for Major Structural Birth Defects in Offspring

Authors: Kharbanda EO; Klein NP; Vaccine Safety Datalink; et al.

J Pediatr. 2017 Aug;187:234-239.e4. Epub 2017-05-24.

PubMed abstract

Maternal Tdap vaccination and risk of infant morbidity

Authors: DeSilva M; Klein NP; Kharbanda EO; et al.

Vaccine. 2017 06 22;35(29):3655-3660. Epub 2017-05-25.

PubMed abstract

Lot-to-lot consistency, safety and immunogenicity of 3 lots of Haemophilus influenzae type b conjugate vaccine: results from a phase III randomized, multicenter study in infants

Authors: Klein NP; Roy-Ghanta S; et al.

Vaccine. 2017 06 16;35(28):3564-3574. Epub 2017-05-20.

PubMed abstract

Waning protection following 5 doses of a 3-component diphtheria, tetanus, and acellular pertussis vaccine

Authors: Klein NP; Bartlett J; Fireman B; Aukes L; Buck PO; Krishnarajah G; Baxter R

Vaccine. 2017 06 08;35(26):3395-3400. Epub 2017-05-12.

PubMed abstract

No association between influenza vaccination during pregnancy and adverse birth outcomes

Authors: Zerbo O; Modaressi S; Chan B; Goddard K; Lewis N; Bok K; Fireman B; Klein NP; Baxter R

Vaccine. 2017 May 31;35(24):3186-3190. Epub 2017-05-05.

PubMed abstract

Asthma exacerbations among asthmatic children receiving live attenuated versus inactivated influenza vaccines

Authors: Ray GT; Lewis N; Goddard K; Ross P; Duffy J; DeStefano F; Baxter R; Klein NP

Vaccine. 2017 05 09;35(20):2668-2675. Epub 2017-04-09.

PubMed abstract

Effectiveness of Vaccination During Pregnancy to Prevent Infant Pertussis

Authors: Baxter R; Bartlett J; Fireman B; Lewis E; Klein NP

Pediatrics. 2017 May;139(5). Epub 2017-04-03.

PubMed abstract

Assessing misclassification of vaccination status: Implications for studies of the safety of the childhood immunization schedule

Authors: Daley MF; Glanz JM; Newcomer SR; Jackson ML; Groom HC; Lugg MM; McLean HQ; Klein NP; Weintraub ES; McNeil MM

Vaccine. 2017 Apr 04;35(15):1873-1878. Epub 2017-03-09.

PubMed abstract

Identifying birth defects in automated data sources in the Vaccine Safety Datalink

Authors: Kharbanda EO; Klein NP; Nordin JD; et al.

Pharmacoepidemiol Drug Saf. 2017 Apr;26(4):412-420. Epub 2017-01-04.

PubMed abstract

Risk factors and familial clustering for fever 7-10days after the first dose of measles vaccines

Authors: Klein NP; Lewis E; McDonald J; Fireman B; Naleway A; Glanz J; Jackson LA; Donahue JG; Jacobsen SJ; Weintraub E; Baxter R

Vaccine. 2017 Mar 14;35(12):1615-1621. Epub 2017-02-21.

PubMed abstract

Time to Change Dosing of Inactivated Quadrivalent Influenza Vaccine in Young Children: Evidence From a Phase III, Randomized, Controlled Trial

Authors: Jain VK; Klein NP; Innis BL; et al.

J Pediatric Infect Dis Soc. 2017 Mar 01;6(1):9-19.

PubMed abstract

Lot-to-Lot Consistency, Safety, Tolerability, and Immunogenicity of an Investigational Hexavalent Vaccine in US Infants

Authors: Block SL; Klein NP; Lee AW; et al.

Pediatr Infect Dis J. 2017 Feb;36(2):202-208.

PubMed abstract

Association Between Influenza Infection and Vaccination During Pregnancy and Risk of Autism Spectrum Disorder

Authors: Zerbo O; Qian Y; Yoshida C; Fireman BH; Klein NP; Croen LA

JAMA Pediatr. 2017 Jan 02;171(1):e163609. Epub 2017-01-02.

PubMed abstract

Acute demyelinating events following vaccines – a case centered analysis

Authors: Baxter R; Lewis E; Goddard K; Fireman B; Bakshi N; DeStefano F; Gee J; Tseng HF; Naleway AL; Klein NP

Clin Infect Dis. 2016 Dec 01;63(11):1456-1462. Epub 2016-09-01.

PubMed abstract

Kaiser Permanente Northern California pregnancy database: Description and proof of concept study

Authors: Zerbo O; Chan B; Goddard K; Lewis N; Bok K; Klein NP; Baxter R

Vaccine. 2016 11 04;34(46):5519-5523. Epub 2016-10-07.

PubMed abstract

Risk of underlying chronic medical conditions for invasive pneumococcal disease in adults

Authors: Baxter R; Yee A; Aukes L; Snow V; Fireman B; Atkinson B; Klein NP

Vaccine. 2016 Aug 05;34(36):4293-7. Epub 2016-07-07.

PubMed abstract

Risk of Preterm or Small-for-Gestational-Age Birth After Influenza Vaccination During Pregnancy: Caveats When Conducting Retrospective Observational Studies

Authors: Vazquez-Benitez G; Klein NP; Nordin JD; et al.

Am J Epidemiol. 2016 Aug 01;184(3):176-86. Epub 2016-07-22.

PubMed abstract

Safety of DTaP-IPV/Hib vaccine administered routinely to infants and toddlers

Authors: Hansen J; Timbol J; Lewis N; Pool V; Decker MD; Greenberg DP; Klein NP

Vaccine. 2016 Jul 29;34(35):4172-4179. Epub 2016-06-30.

PubMed abstract

Febrile Seizure Risk After Vaccination in Children 6 to 23 Months

Authors: Duffy J; Klein NP; Vaccine Safety Datalink; et al.

Pediatrics. 2016 Jul;138(1). Epub 2016-06-06.

PubMed abstract

Sudden-Onset Sensorineural Hearing Loss after Immunization: A Case-Centered Analysis

Authors: Baxter R; Lewis N; Bohrer P; Harrington T; Aukes L; Klein NP

Otolaryngol Head Neck Surg. 2016 Jul;155(1):81-6. Epub 2016-03-29.

PubMed abstract

Case centered analysis of Optic Neuritis following vaccines

Authors: Baxter R; Lewis E; Fireman B; DeStefano F; Gee J; Klein NP

Clin Infect Dis. 2016 Jul 01;63(1):79-81. Epub 2016-04-10.

PubMed abstract

Five-Year Antibody Persistence and Booster Response Following One or Two Doses of Meningococcal A, C, W, and Y Tetanus Toxoid Conjugate Vaccine in Healthy Children

Authors: Klein NP; Baine Y; Kolhe D; Baccarini CI; Miller JM; Van der Wielen M

Pediatr Infect Dis J. 2016 06;35(6):662-72.

PubMed abstract

Influenza Vaccination During Pregnancy: Influenza Seasons 2002-2012, Vaccine Safety Datalink

Authors: Groom HC; Klein NP; Naleway AL; et al.

Am J Prev Med. 2016 Apr;50(4):480-8. Epub 2015-10-31.

PubMed abstract

Risk of anaphylaxis after vaccination in children and adults

Authors: McNeil MM; Klein NP; DeStefano F; et al.

J Allergy Clin Immunol. 2016 Mar;137(3):868-78. Epub 2015-10-06.

PubMed abstract

Waning Tdap Effectiveness in Adolescents

Authors: Klein NP; Bartlett J; Fireman B; Baxter R

Pediatrics. 2016 Mar;137(3):e20153326. Epub 2016-02-05.

PubMed abstract

Maternal Tdap vaccination: Coverage and acute safety outcomes in the vaccine safety datalink, 2007-2013

Authors: Kharbanda EO; Klein NP; Nordin JD; et al.

Vaccine. 2016 Feb 10;34(7):968-73. Epub 2016-01-04.

PubMed abstract

Absence of venous thromboembolism risk following quadrivalent human papillomavirus vaccination, Vaccine Safety Datalink, 2008-2011

Authors: Naleway AL; Klein NP; Vaccine Safety Datalink; et al.

Vaccine. 2016 Jan 2;34(1):167-71. Epub 2015-Nov-06.

PubMed abstract

An Overview of Quadrivalent Human Papillomavirus Vaccine Safety – 2006 to 2015

Authors: Vichnin M; Klein NP; Kuter BJ; et al.

Pediatr Infect Dis J. 2015 Sep;34(9):983-91.

PubMed abstract

Differentiating Sepsis From Adverse Events After Immunization in the Neonatal Intensive Care Unit: How Is a Physician to Know?

Authors: Kuzniewicz MW; Klein NP

JAMA Pediatr. 2015 Aug;169(8):718-9.

PubMed abstract

Safety of Measles-Containing Vaccines in 1-Year-Old Children

Authors: Klein NP; Fireman B; Baxter R; et al.

Pediatrics. 2015 Feb;135(2):e321-9. Epub 2015-01-05.

PubMed abstract

Geographic Clusters in Underimmunization and Vaccine Refusal

Authors: Lieu TA; Ray GT; Klein NP; Chung C; Kulldorff M

Pediatrics. 2015 Feb;135(2):280-9. Epub 2015-01-19.

PubMed abstract

Childhood vaccines and Kawasaki disease, Vaccine Safety Datalink, 1996-2006

Authors: Abrams JY; Klein NP; Belay ED; et al.

Vaccine. 2015 Jan 3;33(2):382-7. Epub 2014-11-04.

PubMed abstract

Does preventing rotavirus infections through vaccination also protect against naturally-occurring intussusception over time?

Authors: Payne DC; Baggs J; Klein NP; Parashar UD

Clin Infect Dis. 2015 Jan 1;60(1):163-4. Epub 2014-09-23.

PubMed abstract

Evaluation of the association of maternal pertussis vaccination with obstetric events and birth outcomes

Authors: Kharbanda EO; Klein NP; Nordin JD; et al.

JAMA. 2014 Nov 12;312(18):1897-904.

PubMed abstract

Receipt of pertussis vaccine during pregnancy across 7 Vaccine Safety Datalink Sites

Authors: Kharbanda EO; Vazquez-Benitez G; Lipkind H; Naleway AL; Klein NP; Cheetham TC; Hambidge SJ; Vellozzi C; Nordin JD

Prev Med. 2014 Oct;67:316-9. Epub 2014-06-18.

PubMed abstract

The Vaccine Safety Datalink: successes and challenges monitoring vaccine safety

Authors: McNeil MM; Klein NP; DeStefano F; et al.

Vaccine. 2014 Sep 22;32(42):5390-8. Epub 2014-08-06.

PubMed abstract

Timely Versus Delayed Early Childhood Vaccination and Seizures

Authors: Hambidge SJ; Klein NP; DeStefano F; et al.

Pediatrics. 2014 Jun;133(6):e1492-9.

PubMed abstract

Safety of diphtheria, tetanus, acellular pertussis and inactivated poliovirus (DTaP-IPV) vaccine

Authors: Daley MF; Klein NP; Weintraub E; et al.

Vaccine. 2014 May 23;32(25):3019-24. Epub 2014-03-31.

PubMed abstract

Live Vaccine Use and Safety in DiGeorge Syndrome

Authors: Hofstetter AM; Jakob K; Klein NP; Dekker CL; Edwards KM; Halsey NA; Baxter R; Williams SE; Graham PL; LaRussa P

Pediatrics. 2014 Apr;133(4):e946-54. Epub 2014-03-31.

PubMed abstract

Risk of Intussusception after Monovalent Rotavirus Vaccination

Authors: Weintraub ES; Klein NP; DeStefano F; et al.

N Engl J Med. 2014 Feb 6;370(6):513-9. Epub 2014-01-14.

PubMed abstract

Vaccinations given during pregnancy, 2002-2009: a descriptive study

Authors: Naleway AL; Klein NP; Weintraub E; et al.

Am J Prev Med. 2014 Feb;46(2):150-7.

PubMed abstract

Protective Association Between Rotavirus Vaccination and Childhood Seizures in the Year Following Vaccination in US Children

Authors: Payne DC; Baggs J; Zerr DM; Klein NP; Yih K; Glanz J; Curns AT; Weintraub E; Parashar UD

Clin Infect Dis. 2014 Jan;58(2):173-7. Epub 2013-11-20.

PubMed abstract

Licensed pertussis vaccines in the United States

Authors: Klein NP

Hum Vaccin Immunother. 2014;10(9):2684-90. Epub 2014-11-06.

PubMed abstract

Effect of Age on the Risk of Fever and Seizures Following Immunization With Measles-Containing Vaccines in Children

Authors: Rowhani-Rahbar A; Fireman B; Klein NP; et al.

JAMA Pediatr. 2013 Dec;167(12):1111-7.

PubMed abstract

Factors that may explain observed associations between trivalent influenza vaccination and gastrointestinal illness in young children

Authors: Newcomer SR; Hambidge SJ; McClure DL; Daley MF; Klein NP; Glanz JM

Vaccine. 2013 Aug 20;31(37):3894-8. Epub 2013-07-02.

PubMed abstract

One or Two Doses of Quadrivalent Meningococcal Serogroups A, C, W-135 and Y Tetanus Toxoid Conjugate Vaccine is Immunogenic in 9-12 Month Old Children

Authors: Klein NP; Baine Y; Bianco V; Lestrate PR; Naz A; Blatter M; Friedland LR; Miller JM

Pediatr Infect Dis J. 2013 Jul;32(7):760-7.

PubMed abstract

Lack of Association of Guillain-Barre Syndrome with Vaccinations

Authors: Baxter R; Bakshi N; Fireman B; Lewis E; Ray P; Vellozzi C; Klein NP

Clin Infect Dis. 2013 Jul;57(2):197-204. Epub 2013-04-11.

PubMed abstract

Cervical Intraepithelial Neoplasia Grade 3 and Adenocarcinoma in situ: Comparison of ICD-9 Codes and Pathology Results – Kaiser Permanente, United States, 2000-2005

Authors: Surie D; Dunne EF; Naleway AL; Weinmann S; Klein NP; Baxter R; Hutchins K; Gee J; Markowitz L

Cancer Epidemiol Biomarkers Prev. 2013 Jun;22(6):1129-32. Epub 2013-04-05.

PubMed abstract

Comprehensive Assessment of Serious Adverse Events Following Immunization by Health Care Providers

Authors: Williams SE; Klein NP; et al.

J Pediatr. 2013 Jun;162(6):1276-81, 1281.e1. Epub 2013 Feb 26.

PubMed abstract

Prevalence of HPV types in cervical specimens from an integrated healthcare delivery system: baseline assessment to measure HPV vaccine impact

Authors: Dunne EF; Klein NP; Unger ER; et al.

Cancer Causes Control. 2013 Feb;24(2):403-7. Epub 2013 Jan 5.

PubMed abstract

Clinical Assessment of Serious Adverse Events in Children Receiving 2009 H1N1 Vaccination

Authors: Pahud BA; Klein NP; Edwards KM; et al.

Pediatr Infect Dis J. 2013 Feb;32(2):163-8.

PubMed abstract

Adapting Group Sequential Methods to Observational Postlicensure Vaccine Safety Surveillance: Results of a Pentavalent Combination DTaP-IPV-Hib Vaccine Safety Study

Authors: Nelson JC; Klein NP; Jackson LA; et al.

Am J Epidemiol. 2013 Jan 15;177(2):131-41. Epub 2013 Jan 4.

PubMed abstract

Kaiser Permanente Vaccine Study Center: Highlights of 2009-2012

Authors: Baxter R; Klein NP

Vaccines (Basel). 2013;1(2):139-53. Epub 2013-04-25.

PubMed abstract

Biologically plausible and evidence-based risk intervals in immunization safety research

Authors: Rowhani-Rahbar A; Klein NP; Dekker CL; Edwards KM; Marchant CD; Vellozzi C; Fireman B; Sejvar JJ; Halsey NA; Baxter R; Risk Interval Working Group of the Clinical Immunization Safety Assessment Network

Vaccine. 2012 Dec 17;31(1):271-7. Epub 2012 Jul 24.

PubMed abstract

Safety of Quadrivalent Human Papillomavirus Vaccine Administered Routinely to Females

Authors: Klein NP; Jacobsen SJ; et al.

Arch Pediatr Adolesc Med. 2012 Dec;166(12):1140-8.

PubMed abstract

Causality assessment of adverse events reported to the Vaccine Adverse Event Reporting System (VAERS)

Authors: Loughlin AM; Klein NP; Jakob K; et al.

Vaccine. 2012 Nov 26;30(50):7253-9. Epub 2012 Oct 9.

PubMed abstract

Waning protection after fifth dose of acellular pertussis vaccine in children

Authors: Klein NP; Bartlett J; Rowhani-Rahbar A; Fireman B; Baxter R

N Engl J Med. 2012 Sep 13;367(11):1012-9.

PubMed abstract

Algorithm to assess causality after individual adverse events following immunizations

Authors: Halsey NA; Edwards KM; Dekker CL; Klein NP; Baxter R; Larussa P; Marchant C; Slade B; Vellozzi C; Causality Working Group of the Clinical Immunization Safety Assessment network

Vaccine. 2012 Aug 24;30(39):5791-8. Epub 2012 Apr 14.

PubMed abstract

Underimmunization at discharge from the neonatal intensive care unit

Authors: Navar-Boggan AM; Halsey NA; Escobar GJ; Golden WC; Klein NP

J Perinatol. 2012 May;32(5):363-7. Epub 2011 Aug 11.

PubMed abstract

Immunogenicity and Safety of Two Tetravalent (Measles, Mumps, Rubella, Varicella) Vaccines Co-Administered with Hepatitis A and Pneumococcal Conjugate Vaccines to Children 12 14 Months of Age

Authors: Blatter MM; Klein NP; Innis BL; et al.

Pediatr Infect Dis J. 2012 Aug;31(8):e133-40.

PubMed abstract

Assessing the safety of influenza vaccination in specific populations: children and the elderly

Authors: Rowhani-Rahbar A; Klein NP; Baxter R

Expert Rev Vaccines. 2012 Aug;11(8):973-84.

PubMed abstract

An unmasking phenomenon in an observational post-licensure safety study of adolescent girls and young women

Authors: Jacobsen SJ; Sy LS; Ackerson BK; Chao CR; Slezak JM; Cheetham TC; Takhar HS; Velicer CM; Hansen J; Klein NP

Vaccine. 2012 Jun 29;30(31):4585-7. Epub 2012 May 11.

PubMed abstract

Immunogenicity and safety of a quadrivalent meningococcal conjugate vaccine administered concomitantly with measles, mumps, rubella, varicella vaccine in healthy toddlers

Authors: Klein NP; Shepard J; Bedell L; Odrljin T; Dull P

Vaccine. 2012 Jun 6;30(26):3929-36. Epub 2012 Apr 10.

PubMed abstract

Comparative immunogenicity and safety of different multivalent component pertussis vaccine formulations and a 5-component acellular pertussis vaccine in infants and toddlers: A randomized, controlled, open-label, multicenter study

Authors: Chatterjee A; O'Keefe C; Varman M; Klein NP; Luber S; Tomovici A; Noriega F

Vaccine. 2012 May 14;30(23):3360-8. Epub 2012 Apr 1.

PubMed abstract

Immunization and Bell’s Palsy in Children: A Case-Centered Analysis

Authors: Rowhani-Rahbar A; Klein NP; Lewis N; Fireman B; Ray P; Rasgon B; Black S; Klein JO; Baxter R

Am J Epidemiol. 2012 May 1;175(9):878-85. Epub 2012 Mar 12.

PubMed abstract

Measles-Containing Vaccines and Febrile Seizures in Children Age 4 to 6 Years

Authors: Klein NP; Lewis E; Baxter R; Weintraub E; Glanz J; Naleway A; Jackson LA; Nordin J; Lieu T; Belongia EA; Fireman B

Pediatrics. 2012 May;129(5):809-14. Epub 2012 Apr 2.

PubMed abstract

Rowhani-Rahbar et al. Respond to ‘Immunization and Bell’s Palsy in Children’

Authors: Rowhani-Rahbar A; Fireman B; Lewis N; Ray P; Rasgon B; Klein JO; Black S; Klein NP; Baxter R

Am J Epidemiol. 2012 Mar 12.

PubMed abstract

Recurrent Guillain-Barre Syndrome Following Vaccination

Authors: Baxter R; Lewis N; Bakshi N; Vellozzi C; Klein NP; CISA Network

Clin Infect Dis. 2012 Mar;54(6):800-4. Epub 2012 Jan 19.

PubMed abstract

Risk of intussusception following administration of a pentavalent rotavirus vaccine in US infants

Authors: Shui IM; Baggs J; Patel M; Parashar UD; Rett M; Belongia EA; Hambidge SJ; Glanz JM; Klein NP; Weintraub E

JAMA. 2012 Feb 8;307(6):598-604.

PubMed abstract

Surveillance of Autoimmune Conditions following Routine Use of Quadrivalent Human Papillomavirus Vaccine

Authors: Chao C; Klein NP; Jacobsen SJ; et al.

J Intern Med. 2012 Feb;271(2):193-203. Epub 2011 Nov 15.

PubMed abstract

An open-label, randomized, multi-center study of the immunogenicity and safety of DTaP-IPV (Kinrix) co-administered with MMR vaccine with or without varicella vaccine in healthy pre-school age children

Authors: Klein NP; Weston WM; Kuriyakose S; Kolhe D; Howe B; Friedland LR; Van Der Meeren O

Vaccine. 2012 Jan 11;30(3):668-74. Epub 2011 Nov 4.

PubMed abstract

Safety and Immunogenicity of a Novel Quadrivalent Meningococcal CRM-Conjugate Vaccine Given Concomitantly With Routine Vaccinations in Infants

Authors: Klein NP; Reisinger KS; Johnston W; Odrljin T; Gill CJ; Bedell L; Dull P

Pediatr Infect Dis J. 2012 Jan;31(1):64-71.

PubMed abstract

Epidemiologic and Clinical Features of Bell’s Palsy among Children in Northern California

Authors: Rowhani-Rahbar A; Baxter R; Rasgon B; Ray P; Black S; Klein JO; Klein NP

Neuroepidemiology. 2012;38(4):252-8. Epub 2012 Jun 5.

PubMed abstract

Developing the next generation of vaccinologists

Authors: Klein NP; DeStefano F; et al.

Vaccine. 2011 Nov 21;29(50):9296-7. Epub 2011 Apr 19.

PubMed abstract

Causality assessment of serious neurologic adverse events following 2009 H1N1 vaccination

Authors: Williams SE; Klein NP; Edwards KM; et al.

Vaccine. 2011 Oct 26;29(46):8302-8. Epub 2011 Sep 3.

PubMed abstract

Monitoring the safety of quadrivalent human papillomavirus vaccine: Findings from the Vaccine Safety Datalink

Authors: Gee J; Fireman B; Klein NP; Weintraub ES; et al.

Vaccine. 2011 Oct 26;29(46):8279-84. Epub 2011 Sep 9.

PubMed abstract

Overview of the Clinical Consult Case Review of adverse events following immunization: Clinical Immunization Safety Assessment (CISA) network 2004-2009

Authors: Williams SE; Klein NP; Edwards KM; et al.

Vaccine. 2011 Sep 16;29(40):6920-7. Epub 2011 Jul 27.

PubMed abstract

Risk of rheumatoid arthritis following vaccination with tetanus, influenza and hepatitis B vaccines among persons 15-59 years of age

Authors: Ray P; Black S; Shinefield H; Dillon A; Carpenter D; Lewis E; Ross P; Chen RT; Klein NP; Baxter R; Vaccine Safety Datalink Team

Vaccine. 2011 Sep 2;29(38):6592-7. Epub 2011 Jul 16.

PubMed abstract

Immunogenicity and Safety of an Inactivated Hepatitis A Vaccine When Coadministered With Diphtheria-tetanus-acellular Pertussis and Haemophilus influenzae Type B Vaccines in Children 15 Months of Age

Authors: Trofa AF; Klein NP; Paul IM; Michaels MG; Goessler M; Chandrasekaran V; Blatter M

Pediatr Infect Dis J. 2011 Sep;30(9):e164-9.

PubMed abstract

Safety of trivalent inactivated influenza vaccine in children aged 24 to 59 months in the vaccine safety datalink

Authors: Glanz JM; Klein NP; Weintraub ES; et al.

Arch Pediatr Adolesc Med. 2011 Aug;165(8):749-55.

PubMed abstract

Attitudes and beliefs of parents concerned about vaccines: impact of timing of immunization information

Authors: Vannice KS; Salmon DA; Shui I; Omer SB; Kissner J; Edwards KM; Sparks R; Dekker CL; Klein NP; Gust DA

Pediatrics. 2011 May;127 Suppl 1:S120-6. Epub 2011 Apr 18.

PubMed abstract

The Vaccine Safety Datalink: a model for monitoring immunization safety

Authors: Baggs J; Klein NP; Weintraub E; et al.

Pediatrics. 2011 May;127 Suppl 1:S45-53. Epub 2011 Apr 18.

PubMed abstract

Understanding the role of human variation in vaccine adverse events: the Clinical Immunization Safety Assessment Network

Authors: Larussa PS; Edwards KM; Dekker CL; Klein NP; Halsey NA; Marchant C; Baxter R; Engler RJ; Kissner J; Slade BA

Pediatrics. 2011 May;127 Suppl 1:S65-73. Epub 2011 Apr 18.

PubMed abstract

Active surveillance for adverse events: the experience of the Vaccine Safety Datalink project

Authors: Yih WK; Fireman BH; Klein NP; Lieu TA; et al.

Pediatrics. 2011 May;127 Suppl 1:S54-64. Epub 2011 Apr 18.

PubMed abstract

Evaluation of immunization rates and safety among children with inborn errors of metabolism

Authors: Klein NP; Aukes L; Lee J; Fireman B; Shapira SK; Slade B; Baxter R; Summar M

Pediatrics. 2011 May;127(5):e1139-46. Epub 2011 Apr 11.

PubMed abstract

Vaccine safety in special populations

Authors: Klein NP;

Hum Vaccin. 2011 Feb;7(2):269-71. Epub 2011 Feb 1.

PubMed abstract

Comparison of the safety and immunogenicity of an investigational and a licensed quadrivalent meningococcal conjugate vaccine in children 2-10 years of age

Authors: Halperin SA; Gupta A; Jeanfreau R; Klein NP; Reisinger K; Walter E; Bedell L; Gill C; Dull PM

Vaccine. 2010 Nov 23;28(50):7865-72. Epub 2010 Oct 29.

PubMed abstract

Vaccine effectiveness against laboratory-confirmed influenza in infants: A matched case control study

Authors: Cochran LW; Black S; Klein NP; Dekker CL; Lewis E; Reingold AL

Hum Vaccin. 2010 Sep 23;6(9). Epub 2010-09-23.

PubMed abstract

Risk of fever and sepsis evaluations after routine immunizations in the neonatal intensive care unit

Authors: Navar-Boggan AM; Halsey NA; Golden WC; Escobar GJ; Massolo M; Klein NP

J Perinatol. 2010 Sep;30(9):604-9. Epub 2010 Feb 25.

PubMed abstract

Lack of association between acellular pertussis vaccine and seizures in early childhood

Authors: Huang WT; Gargiullo PM; Broder KR; Weintraub ES; Iskander JK; Klein NP; Baggs JM; Vaccine Safety Datalink Team

Pediatrics. 2010 Aug;126(2):263-9. Epub 2010 Jul 19.

PubMed abstract

Measles-mumps-rubella-varicella combination vaccine and the risk of febrile seizures

Authors: Klein NP; Fireman B; Vaccine Safety Datalink; et al.

Pediatrics. 2010 Jul;126(1):e1-8. Epub 2010 Jun 29.

PubMed abstract

Post-marketing safety evaluation of a tetanus toxoid, reduced diphtheria toxoid and 3-component acellular pertussis vaccine administered to a cohort of adolescents in a United States health maintenance organization

Authors: Klein NP; Hansen J; Lewis E; Lyon L; Nguyen B; Black S; Weston WM; Wu S; Li P; Howe B; Friedland LR

Pediatr Infect Dis J. 2010 Jul;29(7):613-7.

PubMed abstract

Rates of autoimmune diseases in Kaiser Permanente for use in vaccine adverse event safety studies

Authors: Klein NP; Ray P; Carpenter D; Hansen J; Lewis E; Fireman B; Black S; Galindo C; Schmidt J; Baxter R

Vaccine. 2010 Jan 22;28(4):1062-8. Epub 2009 Nov 5.

PubMed abstract

Preterm infants’ T cell responses to inactivated poliovirus vaccine

Authors: Klein NP; Gans HA; Sung P; Yasukawa LL; Johnson J; Sarafanov A; Chumakov K; Hansen J; Black S; Dekker CL

J Infect Dis. 2010 Jan 15;201(2):214-22.

PubMed abstract

Immunogenicity and tolerability of a quadrivalent meningococcal glycoconjugate vaccine in children 2-10 years of age

Authors: Black S; Klein NP; Shah J; Bedell L; Karsten A; Dull PM

Vaccine. 2010 Jan 8;28(3):657-63. Epub 2009 Nov 4.

PubMed abstract

Real-time surveillance to assess risk of intussusception and other adverse events after pentavalent, bovine-derived rotavirus vaccine

Authors: Belongia EA; Lewis E; Vaccine Safety Datalink Investigation Group; et al.

Pediatr Infect Dis J. 2010 Jan;29(1):1-5.

PubMed abstract

Differential maternal responses to a newly developed vaccine information pamphlet

Authors: Klein NP; Kissner J; Aguirre A; Sparks R; Campbell S; Edwards KM; Dekker CL; Shui I; Gust DA

Vaccine. 2009 Dec 11;28(2):323-8. Epub 2009 Oct 30.

PubMed abstract

Compliance with multiple-dose vaccine schedules among older children, adolescents, and adults: results from a vaccine safety datalink study

Authors: Nelson JC; Klein NP; Jackson LA; et al.

Am J Public Health. 2009 Oct;99 Suppl 2:S389-97.

PubMed abstract

Varicella vaccination and ischemic stroke in children: is there an association?

Authors: Donahue JG; Klein NP; Vaccine Safety Datalink Team; et al.

Pediatrics. 2009 Feb;123(2):e228-34.

PubMed abstract

Recurrent sterile abscesses following aluminium adjuvant-containing vaccines

Authors: Klein NP; Edwards KM; Sparks RC; Dekker CL; Clinical Immunization Safety Assessment (CISA) Network

BMJ Case Rep. 2009;2009. Epub 2009 Mar 17.

PubMed abstract

Kinrix: a new combination DTaP-IPV vaccine for children aged 4-6 years

Authors: Weston WM; Klein NP

Expert Rev Vaccines. 2008 Nov;7(9):1309-20.

PubMed abstract

Diphtheria-tetanus-acellular pertussis and inactivated poliovirus vaccines given separately or combined for booster dosing at 4-6 years of age

Authors: Black S; Friedland LR; Ensor K; Weston WM; Howe B; Klein NP

Pediatr Infect Dis J. 2008 Apr;27(4):341-6.

PubMed abstract

Risk factors for developing apnea after immunization in the neonatal intensive care unit

Authors: Klein NP; Massolo ML; Greene J; Dekker CL; Black S; Escobar GJ; Vaccine Safety Datalink

Pediatrics. 2008 Mar;121(3):463-9.

PubMed abstract

Surveillance for invasive pneumococcal disease during 2000-2005 in a population of children who received 7-valent pneumococcal conjugate vaccine

Authors: Black S; France EK; Isaacman D; Bracken L; Lewis E; Hansen J; Fireman B; Austrian R; Graepel J; Gray S; Klein NP

Pediatr Infect Dis J. 2007 Sep;26(9):771-7.

PubMed abstract

A role for genetics in the immune response to the varicella vaccine

Authors: Klein NP; Fireman B; Enright A; Ray P; Black S; Dekker CL; Clinical Immunization Safety Assessment Network

Pediatr Infect Dis J. 2007 Apr;26(4):300-5.

PubMed abstract

Respiratory distress and transient tachypnea of the newborn

Authors: Klein N

In: Zaoutis LB, Chiang VW, editors. Comprehensive pediatric hospital medicine. Philadelphia: Mosby/Elsevier, 2007.