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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Investigator: Klein, Nicola
Funder: Sanofi Pasteur S.A.
COVID-19 Vaccine Effectiveness in Pregnant Women and their Infants
The overall goals are to: Determine COVID-19 vaccine effectiveness in pregnant women for preventing laboratory-confirmed COVID-19 and hospitalization for COVID-19 using real-world clinical data; Determine effectiveness of maternal COVID-19 vaccination during pregnancy for infants 0-12 months for outcomes of laboratory-confirmed COVID-19, and hospitalization for COVID-19, and determine whether effectiveness varies by trimester of vaccination; Estimate COVID-19 vaccination rates among pregnant women and identify sociodemographic, geographic clusters and other factors associated with being unvaccinated.
Investigator: Zerbo, Ousseny
Funder: National Institute of Allergy and Infectious Diseases
Analysis to evaluate the effectiveness of a serogroup B outer membrane vesicle meningococcal vaccine against gonorrhea
The goal of this study is to use electronic medical records from 2016 to 2020 to evaluate the protective effect of MenB-4C vaccine against gonococcal infections among 16- to 23-year-old persons.
Investigator: Zerbo, Ousseny
Funder: Centers for Disease Control and Prevention
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.
Investigator: Klein, Nicola
Funder: Merck ＆ Company, 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.
Investigator: Klein, Nicola
Funder: Merck ＆ Company, Inc.
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.
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
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.
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
