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Vaccine Study Center

Studies

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

Effect of Maternal Influenza Vaccination during Pregnancy on Risk of Infant Influenza

This project has three major aims: 1) to examine whether influenza vaccination during pregnancy prevents influenza and other respiratory infections in infants aged 0 to 12 months, with a sub-aim to examine the effect of vaccine timing during pregnancy on these outcomes; 2) to evaluate the effect of maternal influenza vaccination during pregnancy on the effectiveness of influenza vaccine administered to infants; and 3) to examine whether influenza non-vaccination during pregnancy clusters geographically, and determine if those clusters are associated with influenza and influenza-like illnesses during pregnancy.
Investigator: Zerbo, Ousseny
Funder: National Institute of Allergy and Infectious Diseases

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 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.

Methods for Safety Evaluation of Vaccination Schedules

In this project, we will develop, evaluate and illustrate a wide variety of new epidemiological methods for studying the safety of childhood vaccination schedules, with respect to a wide variety of different features and components of the vaccine schedule. These include the timing of individual vaccines; the timing between doses of the same vaccine; the interaction effect between vaccines and concurrent health conditions or pharmaceutical medications; the interaction effects of different vaccines given on the same day; the ordering of different vaccines; and the effect of cumulative summary metrics such as the total number of vaccines or the total amount of some vaccine ingredient. Study designs for the comparative evaluation of one or more complete schedules are also covered. Methods will be developed for both for adverse events with an early onset, which are the easiest to study, and for adverse events with a late onset, including serious chronic conditions.
Investigator: Fireman, Bruce
Funder: National Institute of Allergy and Infectious Diseases

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