Nicola P. Klein, MD, PhD

People

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.
Investigator: Klein, Nicola
Funder: Merck ＆ Company, 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.
Investigator: Klein, Nicola
Funder: Pfizer 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.
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.
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.
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.
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
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.
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.
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.
Investigator: Klein, Daniel; Klein, Nicola
Funder: Merck ＆ Company, Inc.

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.
Investigator: Klein, Nicola
Funder: Protein Sciences Corporation

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.
Investigator: Klein, Nicola
Funder: Centers for Disease Control and Prevention

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.
Investigator: Klein, Nicola
Funder: Pfizer Inc.

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.
Investigator: Klein, Nicola
Funder: Shoo the Flu, LLC

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

Investigator: Klein, Nicola
Funder: ICON Clinical Research PLC

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
Investigator: Klein, Nicola
Funder: GlaxoSmithKline 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.
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.
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.
Investigator: Klein, Nicola
Funder: Pfizer Inc.

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.
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.
Investigator: Klein, Nicola
Funder: Centers for Disease Control and Prevention

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.
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.
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.
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.
Investigator: Klein, Nicola
Funder: 

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.
Investigator: Klein, Nicola
Funder: Pfizer Inc.

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.
Investigator: Klein, Nicola
Funder: Merck ＆ Company, 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.
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.
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.
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.
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.
Investigator: Klein, Nicola
Funder: inVentiv Health Clinical, LLC

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

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.
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).
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.
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.
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.
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.
Investigator: Klein, Nicola
Funder: Pfizer Inc.

Beta Hemolytic Streptococcal Infections in a Managed Care Population

Beta Hemolytic Streptococcal Infections in a Managed Care Population
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.
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.
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.
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.
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.
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.
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.
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.
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.
Investigator: Klein, Nicola
Funder: Centers for Disease Control and Prevention

No results found matching criteria

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

Author(s): Vogel TP; Klein NP; Munoz FM; et al.

Vaccine. 2021 Feb 24.

PubMed abstract

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

Author(s): DeDominicis K; Buttenheim AM; Howa AC; Delamater PL; Salmon D; Klein NP; Omer SB

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

PubMed abstract

A Risk Score to Predict Clostridioides difficile Infection

Author(s): Aukes L; Fireman B; Lewis E; Timbol J; Hansen J; Yu H; Cai B; Gonzalez E; Lawrence J; Klein NP

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

PubMed abstract

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

Author(s): Holroyd TA; Howa AC; Proveaux TM; Delamater PL; Klein NP; Buttenheim AM; Limaye RJ; Omer SB; Salmon DA

Hum Vaccin Immunother. 2021 Jan 25:1-8.

PubMed abstract

Genetic associations with a fever after measles-containing vaccines

Author(s): Klein NP; Zerbo O; Goddard K; Wang W; Fohner AE; Wiesner A; Shokoohi V; Coller J; Bok K; Gans HA

Hum Vaccin Immunother. 2020 Dec 22:1-7.

PubMed abstract

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

Author(s): Panagiotakopoulos L; Klein NP; Weintraub ES; et al.

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

PubMed abstract

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

Author(s): Holroyd TA; Howa AC; Delamater PL; Klein NP; Buttenheim AM; Limaye RJ; Proveaux TM; Omer SB; Salmon DA

Hum Vaccin Immunother. 2020 Nov 24:1-6.

PubMed abstract

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

Author(s): Kharbanda EO; Klein NP; Romitti PA; et al.

Pharmacoepidemiol Drug Saf. 2020 Nov 20.

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

Author(s): Abu-Elyazeed R; Klein NP; Moerman L; Povey M; Pruitt A; Senders S; Silas P; Bi D; Rota-090 Study Group

Vaccine. 2020 Oct 16.

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

Author(s): Panagiotakopoulos L; Klein NP; Weintraub ES; et al.

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

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

Author(s): DeDominicis K; Buttenheim AM; Howa AC; Delamater PL; Salmon D; Omer SB; Klein NP

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

PubMed abstract

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

Author(s): Damron FH; Klein NP; Harvill ET; et al.

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

PubMed abstract

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

Author(s): Zerbo O; Ray T; Zhang L; Goddard K; Fireman B; Adams A; Omer S; Kulldorff M; Klein NP

Am J Epidemiol. 2020 Jul 31.

PubMed abstract

Evaluation of a Vaccine-Communication Tool for Physicians

Author(s): Glanternik JR; McDonald JC; Yee AH; Howell A; Saba KN; Mellor RG; Fireman B; Klein NP

J Pediatr. 2020 Jun 06.

PubMed abstract

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

Author(s): 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

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

Author(s): 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 May 15.

PubMed abstract

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

Author(s): Zerbo O; Modaressi S; Glanternik JR; Goddard K; Ross P; Lewis N; Klein NP

Hum Vaccin Immunother. 2020 May 13:1-5.

PubMed abstract

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

Author(s): Dagnew AF; Klein NP; Hervé C; Kalema G; Di Paolo E; Peterson J; Salaun B; Schuind A

J Infect Dis. 2020 Feb 27.

PubMed abstract

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

Author(s): 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

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

Author(s): 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 Feb 20:1-9.

PubMed abstract

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

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

Pediatrics. 2020 Feb 06.

PubMed abstract

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

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

Vaccine. 2020 Jan 25.

PubMed abstract

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

Author(s): Mohanty S; Joyce CM; Delamater PL; Klein NP; Salmon D; Omer SB; Buttenheim AM

Vaccine. 2020 Jan 22.

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

Author(s): Dawood FS; Klein NP; Fell DB; et al.

J Infect Dis. 2019 Dec 26.

PubMed abstract

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

Author(s): Kachikis A; Klein NP; Brighton Collaboration Chorioamnionitis Working Group; et al.

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

PubMed abstract

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

Author(s): Markowitz LE; Klein NP; Aukes L; Timbol J; Unger ER; et al.

J Infect Dis. 2019 Nov 30.

PubMed abstract

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

Author(s): Donahue JG; Klein NP; Belongia EA; et al.

Pediatrics. 2019 Nov 18.

PubMed abstract

Assessment of Exemptions From Vaccination in California, 2015 to 2027

Author(s): Delamater PL; Buttenheim AM; Klein NP; Mohanty S; Salmon DA; Omer SB

Ann Intern Med. 2019 Nov 05.

PubMed abstract

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

Author(s): Zerbo O; Modaressi S; Goddard K; Lewis E; Bok K; Gans H; Klein NP

Hum Vaccin Immunother. 2019 Oct 04.

PubMed abstract

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

Author(s): Groom HC; Klein NP; Naleway AL; et al.

Vaccine. 2019 Sep 20.

PubMed abstract

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

Author(s): Donahue JG; Klein NP; Belongia EA; et al.

Vaccine. 2019 Sep 17.

PubMed abstract

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

Author(s): Ray GT; Lewis N; Klein NP; Daley MF; Lipsitch M; Fireman B

Clin Infect Dis. 2019 Jul 28.

PubMed abstract

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

Author(s): Klein NP; Bartlett J; Fireman B; Marks MA; Hansen J; Lewis E; Aukes L; Saddier P

Vaccine. 2019 Jul 10.

PubMed abstract

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

Author(s): Klein NP; Block SL; Essink B; Barbi S; Smolenov I; Keshavan P

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

PubMed abstract

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

Author(s): Pingali SC; Delamater PL; Buttenheim AM; Salmon DA; Klein NP; Omer SB

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

PubMed abstract

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

Author(s): Klein NP; Fireman B

Clin Infect Dis. 2019 Jun 29.

PubMed abstract

Acellular Pertussis Vaccine Effectiveness Over Time

Author(s): Zerbo O; Bartlett J; Goddard K; Fireman B; Lewis E; Klein NP

Pediatrics. 2019 Jun 10.

PubMed abstract

Incidence of Herpes Zoster Among Children: 2003-2014.

Author(s): Weinmann, Sheila S; Naleway, Allison L AL; Koppolu, Padma P; Baxter, Roger R; Belongia, Edward A EA; Hambidge, Simon J SJ; Irving, Stephanie A SA; Jackson, Michael L ML; Klein, Nicola P NP; Lewin, Bruno B; Liles, Elizabeth E; Marin, Mona M; Smith, Ning N; Weintraub, Eric E; Chun, Colleen C

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

PubMed abstract

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

Author(s): Delamater PL; Pingali SC; Buttenheim AM; Salmon DA; Klein NP; Omer SB

Pediatrics. 2019 May 21.

PubMed abstract

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

Author(s): 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

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

Author(s): Klein NP; Henry O; et al.

J Pediatric Infect Dis Soc. 2019 Mar 08.

PubMed abstract

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

Author(s): Klein NP; Goddard K; Lewis E; Ross P; Gee J; DeStefano F; Baxter R

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

PubMed abstract

Reply to Skowronski, De Serres and Orenstein

Author(s): Thompson MG; Jackson ML; Regan A; Katz MA; Kwong JC; Ball SW; Simmonds K; Klein NP; Naleway A

Clin Infect Dis. 2019 Feb 07.

PubMed abstract

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

Author(s): Naleway AL; Klein NP; Thompson MG; et al.

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

PubMed abstract

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

Author(s): McDonald P; Limaye RJ; Omer SB; Buttenheim AM; Mohanty S; Klein NP; Salmon DA

Vaccine. 2019 Jan 29;37(5):742-750. Epub 2019-01-06.

PubMed abstract

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

Author(s): Winter K; Klein NP; Ackley S; Cherry JD

Sci Transl Med. 2018 Dec 19;10(472).

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

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

Vaccine. 2018 Nov 23.

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

Author(s): Klein NP; Abu-Elyazeed R; Cheuvart B; Janssens W; Mesaros N

Hum Vaccin Immunother. 2018 Nov 16.

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

Author(s): Robertson CA; Mercer M; Selmani A; Klein NP; Jeanfreau R; Greenberg DP

Pediatr Infect Dis J. 2018 Nov 02.

PubMed abstract

A framework for research on vaccine effectiveness

Author(s): Crowcroft NS; Klein NP

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

PubMed abstract

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

Author(s): Thompson MG; Klein NP; PREVENT Workgroup; et al.

Clin Infect Dis. 2018 Oct 11.

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

Author(s): Thompson AR; Klein NP; Schmöele-Thoma B; et al.

Hum Vaccin Immunother. 2018 Oct 10:1-8.

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

Author(s): Schmader KE; Klein NP; Curran D; et al.

J Gerontol A Biol Sci Med Sci. 2018 Sep 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

Author(s): Klein NP; Abu-Elyazeed R; Baine Y; Cheuvart B; Silerova M; Mesaros N

Hum Vaccin Immunother. 2018 Sep 25.

PubMed abstract

Intra-season Waning of Influenza Vaccine Effectiveness

Author(s): Ray GT; Lewis N; Klein NP; Daley MF; Wang SV; Kulldorff M; Fireman B

Clin Infect Dis. 2018 Sep 10.

PubMed abstract

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

Author(s): Zerbo O; Klein NP

JAMA Pediatr. 2018 Aug 06.

PubMed abstract

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

Author(s): Hechter RC; Klein NP; Valdez Nunley K; Aukes L; Tseng HF; et al.

Vaccine. 2018 Jun 26.

PubMed abstract

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

Author(s): Jackson ML; Klein NP; Jackson LA; et al.

Pharmacoepidemiol Drug Saf. 2018 Jun 03.

PubMed abstract

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

Author(s): Regan AK; Klein NP; PREVENT group; et al.

Clin Infect Dis. 2018 May 24.

PubMed abstract

Pneumococcal Conjugate Vaccine Safety in Elderly Adults.

Author(s): Tseng, Hung Fu HF; Sy, Lina S LS; Qian, Lei L; Liu, In-Lu A IA; Mercado, Cheryl C; Lewin, Bruno B; Tartof, Sara Y SY; Nelson, Jennifer J; Jackson, Lisa A LA; Daley, Matthew F MF; Weintraub, Eric E; Klein, Nicola P NP; Belongia, Edward E; Liles, Elizabeth G EG; Jacobsen, Steven J SJ

Open forum infectious diseases. 2018 Jun 19;5(6):ofy100. Epub 2018-05-02.

PubMed abstract

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

Author(s): Daley MF; Klein NP; Glanz JM; et al.

Acad Pediatr. 2018 Mar 28.

PubMed abstract

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

Author(s): Zerbo O; Modaressi S; Goddard K; Lewis E; Fireman BH; Klein NP; et al.

JAMA Pediatr. 2018 Mar 26.

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

Author(s): Klein NP; Habanec T; Kosina P; Shah NR; Kolhe D; Miller JM; Hezareh M; Van der Wielen M

Vaccine. 2018 Mar 22.

PubMed abstract

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

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

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

PubMed abstract

Infant Hospitalizations and Mortality After Maternal Vaccination

Author(s): Sukumaran L; McCarthy NL; Kharbanda EO; Vazquez-Benitez G; Lipkind HS; Jackson L; Klein NP; Naleway AL; McClure DL; Hechter RC; Kawai AT; Glanz JM; Weintraub ES

Pediatrics. 2018 Feb 20.

PubMed abstract

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

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

Pharmacoepidemiol Drug Saf. 2018 Feb 15.

PubMed abstract

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

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

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

PubMed abstract

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

Author(s): Sweet LR; Keech C; Klein NP; Marshall HS; Tagbo BN; Quine D; Kaur P; Tikhonov I; Nisar MI; Kochhar S; Munoz FM; Brighton Collaboration Respiratory Distress in the Neonate Working Group

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

PubMed abstract

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

Author(s): DeSilva M; Munoz FM; Sell E; Marshall H; Tse Kawai A; Kachikis A; Heath P; Klein NP; Oleske JM; Jehan F; Spiegel H; Nesin M; Tagbo BN; Shrestha A; Cutland CL; Eckert LO; Kochhar S; Bardaj A; Brighton Collaboration Congenital Microcephaly Working Group

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

PubMed abstract

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

Author(s): Daley MF; Clarke CL; Glanz JM; Xu S; Hambidge SJ; Donahue JG; Nordin JD; Klein NP; Jacobsen SJ; Naleway AL; Jackson ML; Lee G; Duffy J; Weintraub E

Pharmacoepidemiol Drug Saf. 2017 Nov 17.

PubMed abstract

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

Author(s): Klein NP; Zerbo O

Expert Rev Vaccines. 2017 Oct 20:1-5.

PubMed abstract

Patterns of childhood immunization and all-cause mortality

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

Vaccine. 2017 Oct 20.

PubMed abstract

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

Author(s): Hansen J; Zhang L; Klein NP; Robertson CA; Decker MD; Greenberg DP; Bassily E; Baxter R

Vaccine. 2017 Sep 20.

PubMed abstract

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

Author(s): Eaton A; Lewis N; Fireman B; Hansen J; Baxter R; Gee J; Klein NP

Vaccine. 2017 Sep 13.

PubMed abstract

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

Author(s): Baxter RP; Lewis N; Fireman B; Hansen J; Klein NP; Ortiz JR

Pediatr Infect Dis J. 2017 Sep 12.

PubMed abstract

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

Author(s): 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

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

Author(s): Klein NP; Abu-Elyazeed R; Cornish M; Leonardi ML; Weiner LB; Silas PE; Grogg SE; Varman M; Frenck RW; Cheuvart B; Baine Y; Miller JM; Leyssen M; Mesaros N; Roy-Ghanta S

Vaccine. 2017 Jun 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

Author(s): Klein NP; Bartlett J; Fireman B; Aukes L; Buck PO; Krishnarajah G; Baxter R

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

PubMed abstract

No association between influenza vaccination during pregnancy and adverse birth outcomes

Author(s): 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

Author(s): Ray GT; Lewis N; Goddard K; Ross P; Duffy J; DeStefano F; Baxter R; Klein NP

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

PubMed abstract

Effectiveness of Vaccination During Pregnancy to Prevent Infant Pertussis

Author(s): 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

Author(s): 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

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

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

Vaccine. 2017 Feb 20.

PubMed abstract

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

Author(s): Zerbo O; Qian Y; Yoshida C; Fireman BH; Klein NP; Croen LA

JAMA Pediatr. 2016 Nov 28.

PubMed abstract

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

Author(s): Block SL; Klein NP; Sarpong K; Russell S; Fling J; Petrecz M; Flores S; Xu J; Liu G; Stek JE; Foglia G; Lee AW

Pediatr Infect Dis J. 2016 Nov 11.

PubMed abstract

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

Author(s): Zerbo O; Chan B; Goddard K; Lewis N; Bok K; Klein NP; Baxter R;

​Vaccine. 2016 Nov 4;34(46):5519-5523. doi: 10.1016/j.vaccine.2016.10.006. Epub 2016 Oct 7.

PubMed abstract

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

Author(s): Baxter R; Yee A; Aukes L; Snow V; Fireman B; Atkinson B; Klein NP

Vaccine. 2016 Aug 5;34(36):4293-7. Epub 2016-07-07.

PubMed abstract

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

Author(s): Hansen J; Timbol J; Lewis N; Pool V; Decker MD; Greenberg DP; Klein NP

Vaccine. 2016 Jul 29;34(35):4172-9. Epub 2016-06-30.

PubMed abstract

Recurrent sterile abscesses following aluminium adjuvant-containing vaccines

Author(s): 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

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

Author(s): Vazquez-Benitez G; Kharbanda EO; Naleway AL; Lipkind H; Sukumaran L; McCarthy NL; Omer SB; Qian L; Xu S; Jackson ML; Vijayadev V; Klein NP; Nordin JD

Am J Epidemiol. 2016 Jul 22.

PubMed abstract

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

Author(s): Naleway AL; Crane B; Smith N; Daley MF; Donahue J; Gee J; Greene SK; Harrington T; Jackson LA; Klein NP; Tseng HF; Vellozzi C; Weintraub ES; Vaccine Safety Datalink

Vaccine. 2015 Nov 6.

PubMed abstract

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

Author(s): Kuzniewicz MW; Klein NP

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

PubMed abstract

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

Author(s): Vichnin M; Bonanni P; Klein NP; Garland SM; Block SL; Kjaer SK; Sings HL; Perez G; Haupt RM; Saah AJ; Lievano F; Velicer C; Drury R; Kuter BJ

Pediatr Infect Dis J. 2015 Jun 22.

PubMed abstract

Geographic Clusters in Underimmunization and Vaccine Refusal

Author(s): Lieu TA; Ray GT; Klein NP; Chung C; Kulldorff M

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

PubMed abstract

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

Author(s): Klein NP; Lewis E; Fireman B; Hambidge SJ; Naleway A; Nelson JC; Belongia EA; Yih WK; Nordin JD; Hechter RC; Weintraub E; Baxter R

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

PubMed abstract

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

Author(s): Abrams JY; Weintraub ES; Baggs JM; McCarthy NL; Schonberger LB; Lee GM; Klein NP; Belongia EA; Jackson ML; Naleway AL; Nordin JD; Hambidge SJ; Belay ED

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?

Author(s): 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

Author(s): Kharbanda EO; Vazquez-Benitez G; Lipkind HS; Klein NP; Cheetham TC; Naleway A; Omer SB; Hambidge SJ; Lee GM; Jackson ML; McCarthy NL; DeStefano F; Nordin JD

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

PubMed abstract

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

Author(s): 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

Author(s): McNeil MM; Gee J; Weintraub ES; Belongia EA; Lee GM; Glanz JM; Nordin JD; Klein NP; Baxter R; Naleway AL; Jackson LA; Omer SB; Jacobsen SJ; DeStefano F

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

PubMed abstract

Licensed pertussis vaccines in the United States

Author(s): Klein NP

Hum Vaccin Immunother. 2014 Sep 2;10(9):2684-90. Epub 2014-11-06.

PubMed abstract

Timely Versus Delayed Early Childhood Vaccination and Seizures

Author(s): Hambidge SJ; Newcomer SR; Narwaney KJ; Glanz JM; Daley MF; Xu S; Shoup JA; Rowhani-Rahbar A; Klein NP; Lee GM; Nelson JC; Lugg M; Naleway AL; Nordin JD; Weintraub E; DeStefano F

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

PubMed abstract

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

Author(s): Daley MF; Yih WK; Glanz JM; Hambidge SJ; Narwaney KJ; Yin R; Li L; Nelson JC; Nordin JD; Klein NP; Jacobsen SJ; Weintraub E

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

PubMed abstract

Live Vaccine Use and Safety in DiGeorge Syndrome

Author(s): 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

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

Author(s): Naleway AL; Kurosky S; Henninger ML; Gold R; Nordin JD; Kharbanda EO; Irving S; Craig Cheetham T; Nakasato C; Glanz JM; Hambidge SJ; Davis RL; Klein NP; McCarthy NL; Weintraub E

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

PubMed abstract

Risk of Intussusception after Monovalent Rotavirus Vaccination

Author(s): Weintraub ES; Baggs J; Duffy J; Vellozzi C; Belongia EA; Irving S; Klein NP; Glanz JM; Jacobsen SJ; Naleway A; Jackson LA; DeStefano F

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

PubMed abstract

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

Author(s): Rowhani-Rahbar A; Fireman B; Lewis E; Nordin J; Naleway A; Jacobsen SJ; Jackson LA; Tse A; Belongia EA; Hambidge SJ; Weintraub E; Baxter R; Klein NP

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

PubMed abstract

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

Author(s): 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

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

Author(s): 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

Author(s): 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

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

Author(s): 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

Lack of Association of Guillain-Barre Syndrome with Vaccinations

Author(s): 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

Kaiser Permanente Vaccine Study Center: Highlights of 2009-2012

Author(s): Baxter R; Klein NP

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

PubMed abstract

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

Author(s): Williams SE; Edwards KM; Baxter RP; LaRussa PS; Halsey NA; Dekker CL; Vellozzi C; Marchant CD; Donofrio PD; Reimschisel TE; Berger M; Gidudu JF; Klein NP

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

PubMed abstract

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

Author(s): Pahud BA; Williams SE; Dekker CL; Halsey N; Larussa P; Baxter RP; Klein NP; Marchant CD; Sparks RC; Jakob K; Aukes L; Swope S; Barnett E; Lewis P; Berger M; Dreskin SC; Donofrio PD; Sejvar JJ; Slade BA; Gidudu J; Vellozzi C; Edwards KM

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

PubMed abstract

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

Author(s): Dunne EF; Klein NP; Naleway AL; Baxter R; Weinmann S; Riedlinger K; Fetterman B; Steinau M; Scarbrough MZ; Gee J; Markowitz LE; Unger ER

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

PubMed abstract

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

Author(s): Nelson JC; Yu O; Dominguez-Islas CP; Cook AJ; Peterson D; Greene SK; Yih WK; Daley MF; Jacobsen SJ; Klein NP; Weintraub ES; Broder KR; Jackson LA

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

PubMed abstract

Safety of Quadrivalent Human Papillomavirus Vaccine Administered Routinely to Females

Author(s): Klein NP; Hansen J; Chao C; Velicer C; Emery M; Slezak J; Lewis N; Deosaransingh K; Sy L; Ackerson B; Cheetham TC; Liaw KL; Takhar H; Jacobsen SJ

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)

Author(s): Loughlin AM; Marchant CD; Adams W; Barnett E; Baxter R; Black S; Casey C; Dekker C; Edwards KM; Klein J; Klein NP; Larussa P; Sparks R; Jakob K

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

Author(s): Klein NP; Bartlett J; Rowhani-Rahbar A; Fireman B; Baxter R

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

PubMed abstract

Underimmunization at discharge from the neonatal intensive care unit

Author(s): 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

Assessing the safety of influenza vaccination in specific populations: children and the elderly

Author(s): Rowhani-Rahbar A; Klein NP; Baxter R

Expert Rev Vaccines. 2012 Aug;11(8):973-84.

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

Author(s): Blatter MM; Klein NP; Shepard JS; Leonardi M; Shapiro S; Schear M; Mufson MA; Martin JM; Varman M; Grogg S; London A; Cambron P; Douha M; Nicholson O; da Costa C; Innis BL

Pediatr Infect Dis J. 2012 Aug;31(8):e133-40.

PubMed abstract

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

Author(s): 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

Epidemiologic and Clinical Features of Bell's Palsy among Children in Northern California

Author(s): 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

An unmasking phenomenon in an observational post-licensure safety study of adolescent girls and young women

Author(s): 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

Algorithm to assess causality after individual adverse events following immunizations

Author(s): 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

Immunogenicity and safety of a quadrivalent meningococcal conjugate vaccine administered concomitantly with measles, mumps, rubella, varicella vaccine in healthy toddlers

Author(s): Klein NP; Shepard J; Bedell L; Odrljin T; Dull P

Vaccine. 2012 Jun 6;30(26):3929-36. Epub 2012 Apr 10.

PubMed abstract

Measles-Containing Vaccines and Febrile Seizures in Children Age 4 to 6 Years

Author(s): 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

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

Author(s): 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

Author(s): 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

Rowhani-Rahbar et al. Respond to 'Immunization and Bell's Palsy in Children'

Author(s): 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

Risk of intussusception following administration of a pentavalent rotavirus vaccine in US infants

Author(s): 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

Recurrent Guillain-Barre Syndrome Following Vaccination

Author(s): 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

Safety and Immunogenicity of a Novel Quadrivalent Meningococcal CRM-Conjugate Vaccine Given Concomitantly With Routine Vaccinations in Infants

Author(s): 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

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

Author(s): 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

Monitoring the safety of quadrivalent human papillomavirus vaccine: Findings from the Vaccine Safety Datalink

Author(s): Gee J; Naleway A; Shui I; Baggs J; Yin R; Li R; Kulldorff M; Lewis E; Fireman B; Daley MF; Klein NP; Weintraub ES

Vaccine. 2011 Oct 26;29(46):8279-84. Epub 2011 Sep 9.

PubMed abstract

Causality assessment of serious neurologic adverse events following 2009 H1N1 vaccination

Author(s): Williams SE; Pahud BA; Vellozzi C; Donofrio PD; Dekker CL; Halsey N; Klein NP; Baxter RP; Marchant CD; Larussa PS; Barnett ED; Tokars JI; McGeeney BE; Sparks RC; Aukes LL; Jakob K; Coronel S; Sejvar JJ; Slade BA; Edwards KM

Vaccine. 2011 Oct 26;29(46):8302-8. Epub 2011 Sep 3.

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

Author(s): 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

Author(s): Glanz JM; Newcomer SR; Hambidge SJ; Daley MF; Narwaney KJ; Xu S; Lee GM; Baggs J; Klein NP; Nordin JD; Naleway AL; Belongia EA; Weintraub ES

Arch Pediatr Adolesc Med. 2011 Aug;165(8):749-55.

PubMed abstract

Risk of rheumatoid arthritis following vaccination with tetanus, influenza and hepatitis B vaccines among persons 15-59 years of age

Author(s): 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

Developing the next generation of vaccinologists

Author(s): Klein NP; Gidudu J; Qiang Y; Pahud B; Rowhani-Rahbar A; Baxter R; Dekker CL; Edwards KM; Halsey NA; Larussa P; Marchant C; Tokars JI; DeStefano F

Vaccine. 2011 Nov 21;29(50):9296-7. Epub 2011 Apr 19.

PubMed abstract

Active surveillance for adverse events: the experience of the Vaccine Safety Datalink project

Author(s): Yih WK; Kulldorff M; Fireman BH; Shui IM; Lewis EM; Klein NP; Baggs J; Weintraub ES; Belongia EA; Naleway A; Gee J; Platt R; Lieu TA

Pediatrics. 2011 May;127 Suppl 1:S54-64. Epub 2011 Apr 18.

PubMed abstract

Understanding the role of human variation in vaccine adverse events: the Clinical Immunization Safety Assessment Network

Author(s): 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

The Vaccine Safety Datalink: a model for monitoring immunization safety

Author(s): Baggs J; Gee J; Lewis E; Fowler G; Benson P; Lieu T; Naleway A; Klein NP; Baxter R; Belongia E; Glanz J; Hambidge SJ; Jacobsen SJ; Jackson L; Nordin J; Weintraub E

Pediatrics. 2011 May;127 Suppl 1:S45-53. Epub 2011 Apr 18.

PubMed abstract

Attitudes and beliefs of parents concerned about vaccines: impact of timing of immunization information

Author(s): 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

Evaluation of immunization rates and safety among children with inborn errors of metabolism

Author(s): 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

Author(s): 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

Author(s): 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

Author(s): 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

Lack of association between acellular pertussis vaccine and seizures in early childhood

Author(s): 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

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

Author(s): 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

Measles-mumps-rubella-varicella combination vaccine and the risk of febrile seizures

Author(s): Klein NP; Fireman B; Yih WK; Lewis E; Kulldorff M; Ray P; Baxter R; Hambidge S; Nordin J; Naleway A; Belongia EA; Lieu T; Baggs J; Weintraub E; Vaccine Safety Datalink

Pediatrics. 2010 Jul;126(1):e1-8. Epub 2010 Jun 29.

PubMed abstract

Risk of fever and sepsis evaluations after routine immunizations in the neonatal intensive care unit

Author(s): 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

Preterm infants' T cell responses to inactivated poliovirus vaccine

Author(s): 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

Real-time surveillance to assess risk of intussusception and other adverse events after pentavalent, bovine-derived rotavirus vaccine

Author(s): Belongia EA; Irving SA; Shui IM; Kulldorff M; Lewis E; Yin R; Lieu TA; Weintraub E; Yih WK; Li R; Baggs J; Vaccine Safety Datalink Investigation Group

Pediatr Infect Dis J. 2010 Jan;29(1):1-5.

PubMed abstract

Rates of autoimmune diseases in Kaiser Permanente for use in vaccine adverse event safety studies

Author(s): 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

Immunogenicity and tolerability of a quadrivalent meningococcal glycoconjugate vaccine in children 2-10 years of age

Author(s): 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

Differential maternal responses to a newly developed vaccine information pamphlet

Author(s): 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

Author(s): Nelson JC; Bittner RC; Bounds L; Zhao S; Baggs J; Donahue JG; Hambidge SJ; Jacobsen SJ; Klein NP; Naleway AL; Zangwill KM; Jackson LA

Am J Public Health. 2009 Oct;99 Suppl 2:S389-97.

PubMed abstract

Varicella vaccination and ischemic stroke in children: is there an association?

Author(s): Donahue JG; Kieke BA; Yih WK; Berger NR; McCauley JS; Baggs J; Zangwill KM; Baxter R; Eriksen EM; Glanz JM; Hambidge SJ; Klein NP; Lewis EM; Marcy SM; Naleway AL; Nordin JD; Ray P; Belongia EA; Vaccine Safety Datalink Team

Pediatrics. 2009 Feb;123(2):e228-34.

PubMed abstract

Kinrix: a new combination DTaP-IPV vaccine for children aged 4-6 years

Author(s): 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

Author(s): 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

Author(s): 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

Author(s): 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

Author(s): 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

Author(s): Klein N

In: Zaoutis LB, Chiang VW, editors. Comprehensive pediatric hospital medicine. Philadelphia: Mosby/Elsevier, 2007.

PubMed abstract