Influenza vaccines have been demonstrated to effectively reduce the incidence of influenza infection and potentially associated risks of cardiovascular events in patients with cardiovascular disease (CVD). Despite strong guideline and public health endorsements, global influenza vaccination rates in patients with…
We assessed BNT162b2 vaccine effectiveness (VE) against mild to moderate and severe coronavirus disease 2019 (COVID-19) in children and adolescents through the Omicron BA.4/BA.5 period. Using VISION Network records from April 2021 to September 2022, we conducted a test-negative, case-control…
We assessed coronavirus disease 2019 (COVID-19) vaccination impact on illness severity among adults hospitalized with COVID-19, August 2021-March 2022. We evaluated differences in intensive care unit (ICU) admission, in-hospital death, and length of stay among vaccinated (2 or 3 mRNA…
Influenza vaccination rates remain suboptimal despite effectiveness in preventing influenza infection and related complications. We investigated whether behavioural nudges, delivered via a governmental electronic letter system, would increase influenza vaccination uptake among older adults in Denmark. We did a nationwide,…
During June-October 2022, the SARS-CoV-2 Omicron BA.5 sublineage accounted for most of the sequenced viral genomes in the United States, with further Omicron sublineage diversification through November 2022.* Bivalent mRNA vaccines contain an ancestral SARS-CoV-2 strain component plus an updated…
In the Vaccine Safety Datalink (VSD), we previously reported no association between COVID-19 vaccination in early pregnancy and spontaneous abortion (SAB). The current study aims to understand how time since vaccine roll-out or other methodologic factors could affect results. Using…
NUDGE-FLU was a nationwide, pragmatic, registry-based, cluster-randomized implementation trial during the 2022-23 influenza season in Denmark. NUDGE FLU randomized >960,000 Danish citizens aged 65 years or older to usual care or 9 different behaviorally informed electronic letters (9:1:1:1:1:1:1:1:1:1) promoting influenza…
Recent SARS-CoV-2 Omicron variant sublineages, including BA.4 and BA.5, may be associated with greater immune evasion and less protection against COVID-19 after vaccination. To evaluate the estimated vaccine effectiveness (VE) of 2, 3, or 4 doses of COVID-19 mRNA vaccination…
We examined the effectiveness of maternal vaccination against SARS-CoV-2 infection in 30,311 infants born at Kaiser Permanente Northern California from December 15, 2020, to May 31, 2022. Using Cox regression, the effectiveness of ≥2 doses of COVID-19 vaccine received during…
The safety of COVID-19 vaccines plays an important role in addressing vaccine hesitancy. We conducted a large cohort study to evaluate the risk of non-COVID-19 mortality after COVID-19 vaccination while adjusting for confounders including individual-level demographics, clinical risk factors, health…
In October 2021, Emergency Use Authorization of Coronavirus Disease 2019 (COVID-19) vaccines was granted for children aged 5-11. To ensure vaccine uptake in children upon approval, California will implement a state-wide executive order mandating COVID-19 vaccination for school children following…
During June-October 2022, the SARS-CoV-2 Omicron BA.5 sublineage accounted for most of the sequenced viral genomes in the United States, with further Omicron sublineage diversification through November 2022.* Bivalent mRNA vaccines contain an ancestral SARS-CoV-2 strain component plus an updated…
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.
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.
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…
Persons with moderate-to-severe immunocompromising conditions might have reduced protection after COVID-19 vaccination, compared with persons without immunocompromising conditions (1-3). On August 13, 2021, the Advisory Committee on Immunization Practices (ACIP) recommended that adults with immunocompromising conditions receive an expanded primary…
We examined the effectiveness of maternal vaccination against SARS-CoV-2 infection in 30,288 infants born at Kaiser Permanente Northern California from December 15, 2020, to May 31, 2022. Using Cox regression, the effectiveness of maternal vaccination was 85% (95% confidence interval…
To estimate the effectiveness of mRNA vaccines against moderate and severe covid-19 in adults by time since second, third, or fourth doses, and by age and immunocompromised status. Test negative case-control study. Hospitals, emergency departments, and urgent care clinics in…
Pregnant people are at high risk for severe COVID-19 but were excluded from mRNA vaccine trials; data on COVID-19 vaccine effectiveness (VE) are needed. To evaluate the estimated effectiveness of mRNA vaccination against medically attended COVID-19 among pregnant people during…
Evidence indicates that mRNA COVID-19 vaccination is associated with risk of myocarditis and possibly pericarditis, especially in young males. It is not clear if risk differs between mRNA-1273 versus BNT162b2. We assessed if risk differs using comprehensive health records on…
Coronavirus disease 2019 (COVID-19) breakthrough infections are common. Evaluate in-hospital mortality of patients with COVID-19 by vaccination status using retrospective cohort study. We generated propensity scores for receipt of full vaccination in adults requiring supplemental oxygen hospitalized at Kaiser Permanente…
The Omicron variant (B.1.1.529) of SARS-CoV-2, the virus that causes COVID-19, was first identified in the United States in November 2021, with the BA.1 sublineage (including BA.1.1) causing the largest surge in COVID-19 cases to date. Omicron sublineages BA.2 and…
COVID-19 morbidity is highest in Black and Latino older adults. These racial and ethnic groups initially had lower vaccination uptake than others, and rates in Black adults continue to lag. To evaluate the effect of outreach via electronic secure messages…
The COVID-19 pandemic caused an abrupt drop in in-person health care (inpatient, Emergency Department, outpatient) and an increase in telehealth care, which poses challenges in vaccine safety studies that identify outcomes from in-person encounters. We examined the changes in incidence…
Active immunization with the BNT162b2 vaccine (Pfizer-BioNTech) has been a critical mitigation tool against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection during the coronavirus disease 2019 (Covid-19) pandemic. In light of reports of waning protection occurring 6 months after…
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…
Postauthorization monitoring of vaccines in a large population may detect rare adverse events not identified in clinical trials such as Guillain-Barré syndrome (GBS), which has a background rate of 1 to 2 per 100 000 person-years. To describe cases and incidence…
CDC recommends that all persons aged ≥18 years receive a single COVID-19 vaccine booster dose ≥2 months after receipt of an Ad.26.COV2.S (Janssen [Johnson & Johnson]) adenovirus vector-based primary series vaccine; a heterologous COVID-19 mRNA vaccine is preferred over a…
The efficacy of the BNT162b2 (Pfizer-BioNTech) vaccine against laboratory-confirmed COVID-19 exceeded 90% in clinical trials that included children and adolescents aged 5-11, 12-15, and 16-17 years (1-3). Limited real-world data on 2-dose mRNA vaccine effectiveness (VE) in persons aged 12-17…
Between May 2005 and March 2007, three vaccines were recommended by the Advisory Committee on Immunization Practices for routine use in adolescents in the United States: quadrivalent meningococcal conjugate vaccine (MenACWY), tetanus, diphtheria and acellular pertussis vaccine (Tdap), and human…
CDC recommends that all persons aged ≥12 years receive a booster dose of COVID-19 mRNA vaccine ≥5 months after completion of a primary mRNA vaccination series and that immunocompromised persons receive a third primary dose.* Waning of vaccine protection after…
We are studying the genomes of SARS-CoV-2 in persons with COVID-19 with and without vaccination to identify and describe variants circulating within our patients, including variants of concern (such as Delta or Omicron. We also are assessing which shared genomic…
Estimates of COVID-19 mRNA vaccine effectiveness (VE) have declined in recent months (1,2) because of waning vaccine induced immunity over time,* possible increased immune evasion by SARS-CoV-2 variants (3), or a combination of these and other factors. CDC recommends that…
The COVID-19 pandemic has affected routine vaccine delivery in the US and globally. The magnitude of these disruptions and their association with childhood vaccination coverage are unclear. To compare trends in pediatric vaccination before and during the pandemic and to…
Previous infection with SARS-CoV-2 (the virus that causes COVID-19) or COVID-19 vaccination can provide immunity and protection from subsequent SARS-CoV-2 infection and illness. CDC used data from the VISION Network* to examine hospitalizations in adults with COVID-19-like illness and compared…
Immunocompromised persons, defined as those with suppressed humoral or cellular immunity resulting from health conditions or medications, account for approximately 3% of the U.S. adult population (1). Immunocompromised adults are at increased risk for severe COVID-19 outcomes (2) and might…
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.
In partnership with the California Emerging Infection Program and the California Department of Public Health, Kaiser Permanente Northern California will contribute to statewide whole genome sequencing efforts for surveillance for SARS-CoV-2 variants of concern by submitting samples from all vaccine…
By September 21, 2021, an estimated 182 million persons in the United States were fully vaccinated against COVID-19.* Clinical trials indicate that Pfizer-BioNTech (BNT162b2), Moderna (mRNA-1273), and Janssen (Johnson & Johnson; Ad.26.COV2.S) vaccines are effective and generally well tolerated (1-3).…
There are limited data on the effectiveness of the vaccines against symptomatic coronavirus disease 2019 (Covid-19) currently authorized in the United States with respect to hospitalization, admission to an intensive care unit (ICU), or ambulatory care in an emergency department…
Integrase strand transfer inhibitor (InSTI)-based regimens are now recommended as first-line antiretroviral therapy (ART) for adults with human immunodeficiency virus, but evidence on long-term clinical effectiveness of InSTI-based regimens remains limited. We examined whether InSTI-based regimens improved longer-term clinical outcomes.…
Data on COVID-19 vaccine effectiveness (VE) since the B.1.617.2 (Delta) variant of SARS-CoV-2, the virus that causes COVID-19, became the predominant circulating strain in the United States are limited (1-3). CDC used the VISION Network* to examine medical encounters (32,867)…
In December 2020, the Food and Drug Administration (FDA) issued Emergency Use Authorizations (EUAs) for Pfizer-BioNTech and Moderna COVID-19 vaccines, and in February 2021, FDA issued an EUA for the Janssen (Johnson & Johnson) COVID-19 vaccine. After each EUA, the…
This study will evaluate the safety, tolerability, and efficacy of a booster dose of BNT162b2 when administered to study participants who previously received 2 doses of BNT162b2 at least 6 months prior to randomization.
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…
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.…
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.
Until very recently, vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) had not been authorized for emergency use in persons younger than 16 years of age. Safe, effective vaccines are needed to protect this population, facilitate in-person learning and…
In 2015, California passed Senate Bill 277 eliminating all nonmedical exemptions to school vaccinations. We aimed to explore school-level modes of SB277 enforcement, characterize vaccination knowledge, attitudes, and beliefs of school officials, and identify whether school vaccination policies are associated…
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.
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…
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…
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…
The 9-valent human papillomavirus (9vHPV) vaccine is recommended for individuals through age 26 years and may be administered to women up to age 45 years. Data on 9vHPV vaccine exposures during pregnancy are limited. To evaluate the associations between 9vHPV…
This article presents data that are further analyzed and interpreted in "Shouting at Each Other into the Void: A Semantic Network Analysis of Vaccine Hesitance and Support in Online Discourse Regarding California Law SB277" [1]. This research modified snowball sampling,…
In response to the detection of porcine circovirus type 1 (PCV-1) in the human rotavirus vaccine (HRV), a PCV-free HRV (no detection of PCV-1 and PCV-2 according to the detection limit of tests used) was developed. Liquid (Liq) PCV-free HRV…
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…
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…
In 2015, California passed Senate Bill 277 and became the third state in the United States to ban all nonmedical exemptions from school immunization requirements, effectively prohibiting religious and personal belief exemptions. This attracted grassroots opposition and considerable debate among…
Uptake of influenza vaccine among pregnant women remains low. We investigated whether unvaccinated pregnant women were clustered geographically and determined factors associated with failure to vaccinate using spatial and multivariate logistic regression analyses. Pregnant women who were members of Kaiser…
To describe the safety and tolerability profiles of prophylactic BNT162 vaccines in healthy adults after 1 or 2 doses
Childhood immunization schedules often involve multiple vaccinations per visit. When increased risk of an adverse event is observed after simultaneous (same-day) vaccinations, it can be difficult to ascertain which triggered the adverse event. This methods paper discusses a systematic process…
To evaluate a Kaiser Permanente Northern California physician training tool entitled "Effective Communication without Confrontation" aimed at improving communication with vaccine-hesitant parents, building trust, and alleviating physician stress surrounding vaccination visits. Trainings were held May to July 2015. Pre- and…
Despite high vaccine coverage in many parts of the world, pertussis is resurging in a number of areas in which acellular vaccines are the primary vaccine administered to infants and young children. This is attributed in part to the suboptimal…
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.
MMR II (M-M-R II [Merck & Co, Inc.]) is currently the only measles, mumps, and rubella (MMR) vaccine licensed in the United States. A second MMR vaccine would mitigate the potential risk of vaccine supply shortage or delay. In this…
Bias arises in studies of waning vaccine effectiveness when higher-risk individuals are depleted from the at-risk population at different rates between study groups. We examined how this bias arises and how to avoid it. A reanalysis of data from California…
Highly effective human papillomavirus (HPV) vaccines are used in many national programs in 3- or 2-dose schedules. We examined HPV vaccine effectiveness against HPV prevalence by number of doses. We collected residual liquid-based cytology samples from US women aged 20-29…
Despite recommendations by professional organizations that all pregnant women receive inactivated influenza vaccine, safety concerns remain a barrier. Our objective was to assess the effect of trivalent influenza vaccines (IIV3) during pregnancy on parent report 6-month infant development. We conducted…
Influenza vaccination coverage among pregnant women in the United States is suboptimal. We surveyed women who were pregnant during the 2016-17 influenza season to assess knowledge and attitudes regarding influenza vaccination. We identified and sampled pregnant women to include approximately…
Senate Bill 277 (SB277) banned nonmedical exemptions from school-entry vaccination requirements for children attending classroom-based schools in California, but excluded homeschooled children from vaccination requirements. Thus, it was hypothesized that more parents would choose to homeschool to avoid vaccination requirements…
GlaxoSmithKline Vaccines is currently preparing for clinical trials that evaluate the safety/reactogenicity and immunogenicity of a respiratory syncytial virus maternal vaccine candidate in pregnant women. Robust epidemiological data is needed to support the interpretation of maternal and neonatal outcomes in…
Human papillomavirus is the most common sexually transmitted infection in the United States and causes certain anogenital and oropharyngeal cancers. The 9-valent human papillomavirus vaccine (9vHPV) provides protection against additional types not included in the quadrivalent vaccine. We conducted near…
Vaccine effectiveness studies are subject to biases due to depletion-of-persons at risk of infection, or at especially high risk of infection, at different rates from different groups (depletion-of-susceptibles bias), a problem that can also lead to biased estimates of waning…
Infection with hepatitis A virus (HAV) during pregnancy, although uncommon, is associated with gestational complications and pre-term labor. Hepatitis A vaccine (HepA) is recommended for anyone at increased risk for contracting hepatitis A, including women at risk who are also…
A recent study reported an association between inactivated influenza vaccine (IIV) and spontaneous abortion (SAB), but only among women who had also been vaccinated in the previous influenza season. We sought to estimate the association between IIV administered in three…
We evaluated racial/ethnic differences in prevalence of oncogenic HPV types targeted by the quadrivalent HPV vaccine (16/18) and nonavalent HPV vaccine (31/33/45/52/58) in women diagnosed with CIN2/3/AIS after quadrivalent HPV vaccine introduction (2008-2015). Typing data from 1810 cervical tissue specimen…
Postherpetic neuralgia (PHN) occurs in 5-30% of individuals with herpes zoster (HZ) and is characterized by long-lasting pain. Zoster vaccine live (ZVL) is licensed for people 50 years and older to prevent HZ and PHN. This study evaluated vaccine effectiveness…
The quadrivalent meningococcal conjugate vaccine MenACWY-CRM has been shown to be immunogenic and well-tolerated in infants and toddlers. We evaluated antibody persistence for up to 4 years after vaccination with MenACWY-CRM in the first years of life and response to a…
Herpes zoster and its related complications are associated with significant medical burden, which negatively affects quality of life and daily functioning of the patients. The recently licensed recombinant zoster vaccine (RZV) offers high efficacy but is associated with local and…
California implemented 3 interventions to increase uptake of vaccines. In 2014, Assembly bill 2109 tightened requirements for obtaining a personal belief exemption. A 2015 campaign provided educational materials to school staff on the proper application of conditional admission for kindergartners…
After the 1996 introduction of routine varicella vaccination in the United States, most studies evaluating pediatric herpes zoster (HZ) incidence reported lower incidence over time, with varying degrees of decline. Using the combined databases of 6 integrated health care organizations,…
To determine pertussis risk by diphtheria-tetanus-acellular pertussis (DTaP) vaccination status and time since last DTaP dose. Children born at Kaiser Permanente Northern California between 1999 and 2016 were followed from 3 months of age until they tested positive for pertussis;…
California implemented Senate Bill 277 (SB277) in 2016, becoming the first state in nearly 30 years to eliminate nonmedical exemptions from immunization requirements for schoolchildren. Our objectives were to determine (1) the impacts of SB277 on the percentage of kindergarteners…
This report describes the results of recruitment efforts and the subsequent participation of pregnant women in study activities in a 2010-2012 observational study focused on influenza illness and vaccination in California and Oregon, USA. Socio-demographic and health characteristics extracted from…
We evaluate safety of routine vaccination among adults infected with human immunodeficiency virus (HIV) in five healthcare organizations in the United States. We conducted a retrospective cohort study of HIV-infected adults who received inactivated influenza vaccines, hepatitis B vaccines, pneumococcal…
In the United States, it is recommended that healthcare providers offer influenza vaccination by October, if possible. However, if the vaccine's effectiveness soon begins to wane, the optimal time for vaccination may be somewhat later. We examined whether the effectiveness…
To date, no study has examined influenza vaccine effectiveness (IVE) against laboratory-confirmed influenza-associated hospitalizations during pregnancy. The Pregnancy Influenza Vaccine Effectiveness Network (PREVENT) consisted of public health or healthcare systems with integrated laboratory, medical, and vaccination records in Australia, Canada…
Summary measures such as number of vaccine antigens, number of vaccines, and vaccine aluminum exposure by the 2nd birth day are directly related to parents' concerns that children receive too many vaccines over a brief period. High correlation among summary…
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…
California's Senate Bill 277 (SB-277) law eliminated the personal belief exemption to school immunization requirements. A potential consequence may be that parents choose homeschooling to avoid immunization. Vaccine attitudes and behaviors have not been well studied among the home-schooling population.…
Although pregnant women are believed to have elevated risks of severe influenza infection and are targeted for influenza vaccination, no study to date has examined influenza vaccine effectiveness (IVE) against laboratory-confirmed influenza-associated hospitalizations during pregnancy, primarily because this outcome poses…
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…
Febrile seizures are associated with the first dose of measles-containing vaccines and the risk increases with chronologic age during the second year of life. We used the Vaccine Safety Datalink (VSD) to determine if the relative increase in risk of…
The Advisory Committee on Immunization Practices recommends Hepatitis B (HepB) vaccine for previously unvaccinated adults
Combined hexavalent diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliomyelitis and Haemophilus influenzae type b vaccine (DTaP-HBV-IPV/Hib) can further reduce the number of injections in pediatric immunization schedules of countries currently using pentavalent DTaP combination vaccines. This open-label, randomized, multicenter study (NCT02096263) conducted in…
Immune responses to 13-valent pneumococcal conjugate vaccine (PCV13) and quadrivalent inactivated influenza vaccine (QIV) in older adults may vary with coadministration and previous pneumococcal polysaccharide vaccination. This study assessed safety and noninferiority of immune responses to coadministered PCV13 and QIV…
This phase III, open-label, randomized study (NCT01978093) evaluated the immunogenicity and safety of co-administered Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine (Hib-MenCY-TT) with human rotavirus vaccine (HRV), hepatitis A vaccine (HAV) and 13-valent pneumococcal conjugate…
Limitations in the data used for a recent modeling study of pertussis resurgence in the US may explain why the results were not consistent with several observational studies demonstrating a shorter duration of protection after acellular pertussis vaccine administration.
Few studies have addressed respiratory syncytial virus (RSV) infection during pregnancy. Among 846 pregnant women hospitalized with respiratory illness and tested for RSV, 21 (2%) were RSV positive, of whom 8 (38%) were diagnosed with pneumonia. Despite study limitations, these…
The need for a systematic approach to research on vaccine effectiveness (VE) is increasing with growing numbers of vaccines and complexity of immunization programs. The diverse scientific fields that investigate how vaccines work and why they fail continue to evolve,…
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…
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…
Hepatitis B virus (HBV) infection acquired during pregnancy can pose a risk to the infant at birth that can lead to significant and lifelong morbidity. Hepatitis B vaccine (HepB) is recommended for anyone at increased risk for contracting HBV infection,…
Some parents are concerned the childhood immunization schedule could increase risk for allergic disorders, including asthma. To inform future safety studies of this speculated association, a parent survey was conducted to examine the risk of misclassification of vaccination status in…
The population effectiveness of human papillomavirus (HPV) catch-up vaccination, defined in the USA as first vaccination at ages 13-26 years, has not been studied extensively. We aimed to assess the risk of cervical intraepithelial neoplasia (CIN) 2, CIN3, adenocarcinoma in…
In light of waning immunity to pertussis following receipt of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis (Tdap) vaccine, maintaining protection may require repeated Tdap vaccination. We evaluated the safety of repeated doses of tetanus-containing vaccine in 68 915 nonpregnant…
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…
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
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…
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…
This project will evaluate the school-based influenza vaccine delivery program Shoo the Flu. The program, implemented by Alameda County, delivered influenza vaccines to all K-5 elementary schools in the Oakland Unified School District from 2014 to 2016. This is a…
The 13-valent pneumococcal conjugate vaccine (PCV13) and the 23-valent pneumococcal polysaccharide vaccine (PPSV23) were both recommended to adults aged ≥65 years. The study examines adults ≥65 years for risk of adverse events (AEs) requiring medical attention following vaccination with PCV13…
Following the H1N1 influenza pandemic in 2009, pregnant women were recommended to receive both seasonal (TIV) and H1N1 influenza vaccines. This study presents incidence of adverse birth and pregnancy outcomes among a population of pregnant women immunized with TIV and…
In recent years, rates of vaccination have been declining. Whether this phenomenon disproportionately affects children with autism spectrum disorder (ASD) or their younger siblings is unknown. To investigate if children after receiving an ASD diagnosis obtain their remaining scheduled vaccines…
Live-attenuated influenza vaccines (LAIVs) are not licensed in children younger than 2 years of age because of a wheezing safety signal that has not been fully elucidated. In 2000, the Kaiser Permanente Vaccine Study Center conducted a placebo-controlled randomized clinical…
Individuals with functional or anatomic asplenia are at high risk for meningococcal disease. We evaluated the immunogenicity and safety of 1 and 2 doses of the quadrivalent meningococcal serogroups A, C, W, Y tetanus toxoid-conjugate vaccine (MenACWY-TT) in this high-risk…
Menactra® vaccine (MenACWY-D) was licensed in the United States in 2005 for persons 11-55 years of age, in 2007 for children 2-10 years of age, and in 2011 for infants/toddlers 9-23 months of age. We conducted two studies at Kaiser Permanente Northern California…
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…
The objective of our study was to conduct a data mining analysis to identify potential adverse events (AEs) following MENACWY-D using the tree-temporal scan statistic in the Vaccine Safety Datalink population and demonstrate the feasibility of this method in a…
Some parents are concerned that multiple vaccines in early childhood could weaken their child's immune system. Biological data suggest that increased vaccine antigen exposure could increase the risk for infections not targeted by vaccines. To examine estimated cumulative vaccine antigen…
The Advisory Committee on Immunization Practices currently recommends pregnant women receive influenza and tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccines. There are limited studies of the long-term safety in infants for vaccines administered during pregnancy. We evaluate…
The need to develop methods for studying the safety of childhood immunization schedules has been recognized by the Institute of Medicine and Department of Health and Human Services. The recommended childhood immunization schedule includes multiple vaccines in a visit. A…
The Institute of Medicine recommended conducting observational studies of childhood immunization schedule safety. Such studies could be biased by outcome misclassification, leading to incorrect inferences. Using simulations, we evaluated (1) outcome positive predictive values (PPVs) as indicators of bias of…
We sought to determine the real-world effectiveness of respiratory syncytial virus (RSV) immunoprophylaxis in a population-based cohort to inform policy. The study population included infants born 1996-2008 and enrolled in Kaiser Permanente Northern California. During the RSV season (November-March), RSV…
A live attenuated zoster vaccine was licensed in the United States in 2006 for prevention of shingles in persons aged 60 years or older; the indication was extended in 2011 to cover those aged 50-59 years. We assessed vaccine effectiveness…
To evaluate the safety of live attenuated influenza vaccine (LAIV) in children 2 through 17 years of age. The study was conducted in 6 large integrated health care organizations participating in the Vaccine Safety Datalink (VSD). Trivalent LAIV safety was assessed…
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…
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.
Evidence supports the safety of the recommended childhood immunization schedule as a whole. However, additional research is warranted as parents' refusing or delaying vaccinations has increased in recent years. All-cause mortality has been identified as a priority outcome to study…
Despite robust vaccination schedules and high vaccination rates, many countries, including the U.S., have seen large pertussis outbreaks with a shift in recent years in the distribution of disease burden towards adolescents and young adults. Areas covered: This perspective covers…
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…
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…
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…
Influenza-like illness and inflammation are known risk factors for venous thromboembolism (VTE), which includes deep vein thrombosis (DVT) and pulmonary embolism (PE). However, few studies have characterized the risk of VTE following influenza vaccination. We examined VTE risk after vaccination…
Menactra� vaccine (MenACWY-D) was licensed in the United States in 2005 for persons 11-55years of age. The aim of this study was to assess the safety of MenACWY-D administered as part of routine clinical care to patients at Kaiser Permanente…
As an important quality measure, the rates of recommended immunizations among immunocompromised inflammatory bowel disease (IBD) patients in community practice have not been well studied. This study sought to investigate the rates and predictors of recommended immunizations and screening tests…
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…
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…
Vaccination against Haemophilus influenzae type b (Hib) is included in routine pediatric immunization schedule in the United States. Previous vaccine shortages have created the need for additional options for Hib vaccination. This phase III, randomized, multi-centered study (NCT01000974) evaluated the…
The effectiveness of diphtheria, tetanus, and acellular pertussis (DTaP) vaccines wanes substantially after the 5thdose given at ages 4-6years, but has not been described following 5 doses of the same type of DTaP vaccine. We investigated waning effectiveness against pertussis…
Pregnant women are recommended to receive inactivated influenza vaccination anytime during pregnancy. Studies have investigated the impact of influenza vaccination during pregnancy on birth outcomes and results on preterm birth have been inconsistent. We conducted a retrospective cohort study among…
To investigate whether there is a difference in the risk of asthma exacerbations between children with pre-existing asthma who receive live attenuated influenza vaccine (LAIV) compared with inactivated influenza vaccine (IIV). We identified IIV and LAIV immunizations occurring between July…
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.
Vaccination against pertussis during pregnancy is recommended to protect newborns, yet there is limited information about the effectiveness of maternal tetanus toxoid, reduced diphtheria toxoid, acellular pertussis (Tdap) vaccine before the first infant dose of diphtheria, tetanus and acellular pertussis…
To address public concern about the safety of the childhood immunization schedule, the Institute of Medicine recommended observational studies comparing adverse health outcomes of fully vaccinated children to children under-vaccinated due to parental choice. Misclassification of vaccination status could bias…
Seven to ten days after a first dose of a measles-containing vaccine (MCV; i.e., MMR or MMRV), children have elevated fever risk which can be associated with febrile seizures. This study investigated individual and familial factors associated with fever 7-10days…
A phase II, double-blind, randomized, multicenter study to evaluate the safety, tolerability, and immunogenicity of V114 compared to Prevnar13 in healthy infants.
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.
Few national studies have asked parents how to improve the childhood vaccination process. We surveyed a nationally representative online panel of parents on how to improve this process, rationales for nonstandard approaches, and alternatives to the standard schedule. Twelve percent…
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…
Post-marketing observational study of safety following vaccination with Flublok compared to Licensed IIV in adults 18 years of age and older.
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…
The California Emerging Infections Program will collaborate with the California Department of Health Services to develop a comprehensive plan to conduct systematic population-based cervical intraepithelial neoplasia surveillance and implement a pilot project in Alameda County. This population-based surveillance project aims…
Respiratory syncytial virus (RSV) surveillance in mothers and newborns.
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…
Clinical trial of staphylococcus aureus 4-Antigen 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…
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,…
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.
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…
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.
Surgical site infection rates for patients undergoing elective posterior lumbar spinal fusion surgery in Kaiser Permanente Northern California hospitals.
Beta Hemolytic Streptococcal Infections in a Managed Care Population
This study will develop a multi-country collaboration to investigate the preventive value of IIV during pregnancy using retrospective cohort and case-control study designs. Specifically, we aim to: 1. Estimate influenza inactivated vaccine (IIV) effectiveness in preventing acute respiratory or febrile…
This study has two main objectives: 1) To examine the impact of electronic provider reminders on HepB vaccine initiation rate among previously unvaccinated adults diagnosed with diabetes who were 19-59 years old; and 2) To examine the impact of electronic…
This study will determine the age-specific rates of laboratory-confirmed influenza associated hospitalization among children and describe clinical and epidemiologic characteristics of pediatric hospitalized case-patients during the 2003-2004 influenza season.
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…
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…
This study consists of data collection on patients receiving treatment with Prevnar (13vPnC) as part of their standard medical care.
This study consists of data collection on patients receiving treatment with Prevnar (13vPnC) as part of their standard medical care.
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…
The study is non-interventional and consists of data collection on patients receiving treatment as part of their standard medical care for C.Diff.
Human papillomavirus vaccination may result in lowered intention to be screened for cervical cancer, potentially leading to gaps in screening coverage and avoidable cervical cancer diagnoses. The purpose of this study was to examine the association between human papillomavirus vaccination…
This multicenter phase III study (NCT01340937) evaluated the consistency of immune responses to 3 separate lots of diphtheria-tetanus toxoids-acellular pertussis 5, inactivated poliovirus vaccine, Haemophilus influenzae type b, and hepatitis B (DTaP5-IPV-Hib-HepB), an investigational hexavalent vaccine (HV). Healthy infants were…
CISA strives to understand adverse events following immunization (AEFIs) in order to advise providers and patients regarding management and revaccination. The clinical consult reviews are part of this process. Many of the AEFIs discussed in the consultations are rare, and…
The objectives of the project are to: 1) design and incorporate a system-wide intervention (see required elements below) to promote HPV vaccination among adolescent males and females aged 11-18 years, 2) implement the intervention, which should target providers, administrative and…
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…
"The purpose of this contract 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…
The purpose of this indefinite delivery, indefinite quantity (IDIQ) contract is to provide the Centers for Disease Control and Prevention (CDC), National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Division of Healthcare Quality Promotion (DHQP), Immunization Safety Office (ISO),…
This study is non-interventional and consists of data collection on patients receiving Pfizer product Prevnar 13.
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.
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…
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…
CISA strives to understand adverse events following immunization (AEFIs) in order to advise providers and patients regarding management and revaccination. Clinical consult reviews are part of this process. Many of the AEFIs discussed in the consultations are rare, and there…
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…
The purpose of this project is to provide the Centers for Disease Control and Prevention (CDC), National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Division of Healthcare Quality Promotion (DHQP), Immunization Safety Office (ISO), an as needed mechanism to…
Maternal infections and fever during pregnancy are associated with increased risk for autism spectrum disorders (ASDs). To our knowledge, no study has investigated the association between influenza vaccination during pregnancy and ASD. To investigate the association between influenza infection and…
As part of a survey of about vaccination beliefs, a nationally representative sample of parents of young children answered a series of tradeoff questions that asked them to choose between two vaccination approaches that differed in terms of risks of…
We describe the establishment of a dynamic database linking mothers to newborns with the goal of studying vaccine safety in both pregnant women and their children and provide results of a study utilizing this database as a proof of concept.…
In the United States, the 13-valent pneumococcal conjugate vaccine is recommended in persons ⩾65years of age, and persons ⩽65years of age with immunocompromising (IC) conditions. For invasive pneumococcal disease (IPD) prevention in those ⩽65 with non-IC medical conditions, the 23-valent…
Vaccines are increasingly targeted toward women of reproductive age, and vaccines to prevent influenza and pertussis are recommended during pregnancy. Prelicensure clinical trials typically have not included pregnant women, and when they are included, trials cannot detect rare events. Thus,…
The combination DTaP-IPV/Hib vaccine was licensed in the United States in 2008 for children ages 6weeks through 4years with doses administered at 2, 4, 6, and 15-18months of age. The aim of this study was to assess the safety of…
To investigate concerns about a potential association between quadrivalent human papillomavirus vaccination (HPV4) and venous thromboembolism (VTE), we conducted a self-controlled case series study in adolescents and young adults 9-26 years of age in the Vaccine Safety Datalink. We identified…
A quadrivalent human papillomavirus (HPV4) type 6/11/16/18 vaccine (GARDASIL/SILGARD®) has been licensed in many countries around the world for the prevention of cervical, vulvar, vaginal, and anal cancers and precancers, as well as external genital warts causally related to HPV…
Although pregnant women are a high-priority group for seasonal influenza vaccination, vaccination rates in this population remain below target levels. Previous studies have identified sociodemographic predictors of vaccine choice, but relationships between preconception heath behaviors and seasonal influenza vaccination are…
This observational study followed a cohort of pregnant women during the 2010-2011 influenza season to determine factors associated with vaccination. Participants were 1105 pregnant women who completed a survey assessing health beliefs related to vaccination upon enrollment and were then…
The Postlicensure Rapid Immunization Safety Monitoring Program, the vaccination safety monitoring component of the US Food and Drug Administration's Mini-Sentinel project, is currently the largest cohort in the US general population for vaccine safety surveillance. We developed a study design…
A growing number of parents adopt alternative vaccination schedules for their children. A better understanding of parents' rationales for these choices is needed to guide vaccine decision making. We conducted 24 semistructured telephone interviews with parents of 12- to 36-month-olds…
All measles-containing vaccines are associated with several types of adverse events, including seizure, fever, and immune thrombocytopenia purpura (ITP). Because the measles-mumps-rubella-varicella (MMRV) vaccine compared with the separate measles-mumps-rubella (MMR) and varicella (MMR + V) vaccine increases a toddler's risk…
Parental refusal and delay of childhood vaccines has increased in recent years and is believed to cluster in some communities. Such clusters could pose public health risks and barriers to achieving immunization quality benchmarks. Our aims were to (1) describe…
Kawasaki disease is a childhood vascular disorder of unknown etiology. Concerns have been raised about vaccinations being a potential risk factor for Kawasaki disease. Data from the Vaccine Safety Datalink were collected on children aged 0-6 years at seven managed…
In 2010, due to a pertussis outbreak and neonatal deaths, the California Department of Health recommended that the tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) be administered during pregnancy. Tdap is now recommended by the Advisory Committee…
In response to widespread pertussis outbreaks and infant deaths, in 2010, the California Department of Health (CDPH) and in 2011 the Advisory Committee on Immunization Practices (ACIP) advised that the tetanus toxoid, reduced diphtheria toxoid and acellular pertussis (Tdap) vaccine…
Large healthcare databases maintained by health plans have been widely used to conduct customized protocol-based epidemiological safety studies as well as targeted routine sequential monitoring of suspected adverse events for newly licensed vaccines. These databases also offer a rich data…
The Vaccine Safety Datalink (VSD) is a collaborative project between the Centers for Disease Control and Prevention (CDC) and 9 health care organizations. Established in 1990, VSD is a vital resource informing policy makers and the public about the safety…
When varicella vaccine was licensed in the United States in 1995, there were concerns that childhood vaccination might increase the number of adolescents susceptible to varicella and shift disease toward older age groups where it can be more severe. We…
Little is known regarding the timing of childhood vaccination and postvaccination seizures. In a cohort of 323?247 US children from the Vaccine Safety Datalink born from 2004 to 2008, we analyzed the association between the timing of childhood vaccination and…
In 2008, a diphtheria, tetanus, acellular pertussis, and inactivated poliovirus combined vaccine (DTaP-IPV) was licensed for use in children 4 through 6 years of age. While pre-licensure studies did not demonstrate significant safety concerns, the number vaccinated in these studies…
Live vaccines are generally contraindicated in patients with DiGeorge syndrome (DGS), a congenital disorder characterized by cellular immune deficiency. Vaccine utilization and safety in this population are not well described. This study examined vaccination patterns and adverse events following live…
International postlicensure studies have identified an increased risk of intussusception after vaccination with the second-generation rotavirus vaccines RotaTeq (RV5, a pentavalent vaccine) and Rotarix (RV1, a monovalent vaccine). We studied this association among infants in the United States. The study…
Although current rotavirus vaccines were not associated with an increased risk of intussusception in large trials before licensure, recent postlicensure data from international settings suggest the possibility of a small increase in risk of intussusception after monovalent rotavirus vaccination. We…
A number of studies have described influenza vaccination coverage during pregnancy but few publications have described rates of other vaccinations. To describe vaccination rates during pregnancy in the Vaccine Safety Datalink (VSD), with particular focus on vaccinations contraindicated during pregnancy.…
Although vaccination with trivalent inactivated influenza vaccine (TIV) is recommended for all pregnant women, no vaccine effectiveness (VE) studies of TIV in pregnant women have assessed laboratory-confirmed influenza outcomes. We conducted a case-control study over 2 influenza seasons (2010-2011 and…
Rotavirus illness has been linked to childhood seizures. We investigated whether a protective association exists between receipt of rotavirus vaccine and being hospitalized or visiting the emergency department for seizures in the year after vaccination. We retrospectively analyzed a cohort…
Managing emerging vaccine safety signals during an influenza pandemic is challenging. Federal regulators must balance vaccine risks against benefits while maintaining public confidence in the public health system. We developed a multi-criteria decision analysis model to explore regulatory decision-making in…
The United States switched from whole cell to acellular pertussis vaccines in the 1990s following global concerns with the safety of the whole cell vaccines. Despite high levels of acellular pertussis vaccine coverage, the United States and other countries are…
The Post-Licensure Rapid Immunization Safety Monitoring (PRISM) program is the immunization safety monitoring component of FDA's Mini-Sentinel project, a program to actively monitor the safety of medical products using electronic health information. FDA sought to assess the surveillance capabilities of…
IMPORTANCE The first dose of live attenuated measles-containing vaccines is associated with an increased risk of febrile seizures 7 to 10 days following immunization among 12- to 23-month-old children. The combination measles, mumps, rubella, and varicella vaccine is associated with…
Previously published studies reported an increased risk of gastrointestinal illness in the 14 days following trivalent influenza vaccination (TIV) in young children. While gastrointestinal illness may be a true adverse effect of TIV, other factors may influence this observed association,…
The incidence of invasive meningococcal disease is highest in infants. A quadrivalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine (MenACWY-TT) was evaluated in children 9-12 months of age. We randomized infants (1:1) to receive 1 dose…
Guillain-Barré syndrome (GBS) is an acute polyradiculoneuropathy, thought to be an autoimmune process. Although cases of GBS have been reported following a wide range of vaccines, a clear association has only been established with the 1976 H1N1 inactivated influenza vaccine.…
Cervical intraepithelial neoplasia grade 3+ (CIN3+) and adenocarcinoma in situ incidence will be an important measure of HPV vaccine impact. Integrated healthcare delivery systems, such as Kaiser Permanente, could be used to monitor CIN3+ trends; however, limited evaluations of data…
BACKGROUND: Varicella vaccine was licensed in the United States in 1995 for individuals >/=12 months of age. A second dose was recommended in the United States in June 2006. Varicella incidence and vaccine effectiveness were assessed in a 14-year prospective…
PURPOSE: Two human papillomavirus (HPV) vaccines are available to prevent cervical cancer. One early measure of HPV vaccine impact would be a reduction in vaccine-related HPV types (HPV 6, 11, 16, or 18, or HPV 16, 18) in cervical samples…
BACKGROUND: Monovalent 2009 H1N1 influenza vaccines were licensed and administered in the United States during the H1N1 influenza pandemic between 2009 and 2013. METHODS: Vaccine Adverse Event Reporting System received reports of adverse events following immunization (AEFI) after H1N1 vaccination.…
To address gaps in traditional postlicensure vaccine safety surveillance and to promote rapid signal identification, new prospective monitoring systems using large health-care database cohorts have been developed. We newly adapted clinical trial group sequential methods to this observational setting in…
The Kaiser Permanente Vaccine Study Center is a specialized research organization in Oakland, California. They have been an active vaccine research group for many years, and have participated in and led a multitude of vaccine studies. This article will review…
In immunization safety research, individuals are considered at risk for the development of certain adverse events following immunization (AEFI) within a specific period of time referred to as the risk interval. These intervals should ideally be determined based on biologic…
OBJECTIVE: To assess the safety of the quadrivalent human papillomavirus vaccine (HPV4) in females following routine administration. DESIGN: In a cohort of vaccinated females, we compared the risk of emergency department visits and hospitalizations during the interval soon after vaccination…
Adverse events following immunization (AEFI) reported to the national Vaccine Adverse Event Reporting System (VAERS) represent true causally related events, as well as events that are temporally, but not necessarily causally related to vaccine. OBJECTIVE: We sought to determine if…
In response to the 2009 H1N1 pandemic and subsequent vaccination program, the Department of Health and Human Services and collaborators developed the Post-Licensure Rapid Immunization Safety Monitoring (PRISM) Program as a demonstration project to detect rare adverse events rapidly. The…
BACKGROUND: Zostavax is a live, attenuated varicella-zoster virus vaccine indicated for the prevention of herpes zoster (shingles). An observational post-licensure (Phase IV) study was conducted at Kaiser Permanente Northern California (KPNC), a US managed care organization, to assess the safety…
BACKGROUND: In the United States, children receive five doses of diphtheria, tetanus, and acellular pertussis (DTaP) vaccine before 7 years of age. The duration of protection after five doses of DTaP is unknown. METHODS: We assessed the risk of pertussis…
Assessing individual reports of adverse events following immunizations (AEFI) can be challenging. Most published reviews are based on expert opinions, but the methods and logic used to arrive at these opinions are neither well described nor understood by many health…
OBJECTIVE: To examine the effectiveness of pneumococcal polysaccharide vaccine (PPV) among approximately 40,000 community-dwelling men aged 45 years and older in the California Men's Health Study (CMHS) cohort. METHODS: All participants completed an extensive questionnaire at baseline (2002-2003) and were…
OBJECTIVE: The objectives of this study are to determine immunization rates at discharge from the neonatal intensive care unit (NICU) among infants 2 months of age and above and to evaluate risk factors for underimmunization. STUDY DESIGN: A retrospective cohort…
BACKGROUND:: This study compared single-dose tetravalent measles, mumps, rubella, varicella (MMRV) vaccine, Priorix-Tetra, stored refrigerated (GSK+4C) or frozen (GSK 20C), with ProQuad (Merck-20C), when co-administered with hepatitis A vaccine (HAV) and 7-valent pneumococcal conjugate vaccine (PCV7). METHODS:: Multicenter, observer-blind Phase…
Comprehensive monitoring of the safety of influenza vaccines remains a public health priority, particularly as immunization coverage increases across different age groups at the global level. In this review, the authors provide state-of-the-art knowledge on the safety of influenza immunization…
Our recent experience in a post-licensure safety study of autoimmune conditions following the quadrivalent human papillomavirus vaccine in 189,629 girls and young women ages 9-26 years led us to question the adequacy of the exclusion of Day 0 events to…
BACKGROUND: Invasive meningococcal disease can have devastating outcomes, especially in high-risk groups such as infants. As infants are recommended to receive multiple vaccines during a single office visit, this phase 3 study assessed the safety and immune response to MenACWY-CRM…
An increased risk of Guillain-Barre syndrome (GBS) following administration of the 1976 swine influenza vaccine led to a heightened focus on GBS when monovalent vaccines against a novel influenza A (H1N1) virus of swine origin were introduced in 2009. GBS…
BACKGROUND: Pentavalent and quadrivalent combination vaccine formulations from the same manufacturer (DTaP-IPV/Hib [PENTA], DTaP-IPV [QUAD]) were investigated as to whether they were sufficiently interchangeable to tailor use to local preference or availability. METHODS: A randomized, controlled, open-label, 4-armed, multicenter study…
OBJECTIVES: The aim of this study was to examine a large cohort of adults who received the zoster vaccine for evidence of an increased risk of prespecified adverse events requiring medical attention. DESIGN: Two self-comparison approaches, including a case-centred approach…
Bell's palsy (BP) is an acute and idiopathic paralysis of the facial nerve, with an estimated incidence ranging from 11.5 per 100,000 person-years to 53.3 per 100,000 person-years in different populations. BP has been reported following immunization with inactivated trivalent…
BACKGROUND: In the United States, children receive 2 doses of measles-mumps-rubella vaccine (MMR) and varicella vaccine (V), the first between ages 1 to 2 years and the second between ages 4 to 6 years. Among 1- to 2-year-olds, the risk…
BACKGROUND: Guillain-Barre syndrome (GBS) is an acute polyradiculopathy, thought to be autoimmune, which has been reported following vaccinations. The Advisory Committee on Immunization Practices recommends not administering influenza vaccine to individuals who have had a history of GBS within 6…
CONTEXT: Current rotavirus vaccines were not associated with intussusception in large prelicensure trials. However, recent postlicensure data from international settings suggest the possibility of a low-level elevated risk, primarily in the first week after the first vaccine dose. OBJECTIVE: To…
BACKGROUND: In the US, it is recommended that 4-6 year old children receive diphtheria-tetanus-acellular pertussis (DTaP), inactivated poliovirus (IPV), measles-mumps-rubella (MMR), varicella (V), and influenza vaccines. Data relating to the concomitant administration of combination DTaP-IPV vaccine (Kinrix; GlaxoSmithKline Biologicals) and…
OBJECTIVE: A number of new and combination vaccines have been introduced for children in the past two decades. Encephalitis cases occurring within defined time windows following administration of pertussis- or measles-containing vaccines are eligible for compensation by the Vaccine Injury…
BACKGROUND: In phase II studies, MenACWY-CRM elicited robust immunologic responses in young infants. We now present results from our pivotal phase III infant immunogenicity/safety study. METHODS: In this open-label phase III study, we randomized full-term 2-month-old infants to 4 doses…
BACKGROUND: Bell's palsy (BP) is an acute, idiopathic, and usually unilateral paralysis of the facial nerve. Large population-based studies of BP among children are lacking. We determined epidemiologic and clinical features of BP among children enrolled in a large integrated…
BACKGROUND: Adverse events occurring after vaccination are routinely reported to the Vaccine Adverse Event Reporting System (VAERS). We studied serious adverse events (SAEs) of a neurologic nature reported after receipt of influenza A (H1N1) 2009 monovalent vaccine during the 2009-2010…
BACKGROUND: In 7 large managed care organizations (MCOs), we performed a post-licensure safety assessment of quadrivalent human papillomavirus vaccine (HPV4) among 9-26 year-old female vaccine recipients between August 2006 and October 2009. METHODS: Sequential analyses were conducted weekly to detect…
BACKGROUND: In 2004 the Clinical Consult Case Review (CCCR) working group was formed within the CDC-funded Clinical Immunization Safety Assessment (CISA) Network to review individual cases of adverse events following immunizations (AEFI). METHODS: Cases were referred by practitioners, health departments,…
BACKGROUND: Associations between vaccinations, particularly hepatitis B, and onset of rheumatoid arthritis (RA) have been reported, but examined in few large-scale studies. METHOD: Onset of RA cases and dates of vaccination against hepatitis B, tetanus, and influenza were identified in…
BACKGROUND: This study (NCT00197236) evaluated the safety and immunogenicity of a hepatitis A virus (HAV) vaccine when coadministered with diphtheria-tetanus-acellular pertussis (DTaP) and Haemophilus influenzae type b (Hib) vaccines in children 15 months of age. METHODS: This was an open-labeled,…
OBJECTIVES: To evaluate the safety of trivalent inactivated influenza vaccine (TIV) in children aged 24 to 59 months and to evaluate the risk of medically attended events (MAEs) in a subcohort of children who had multiple annual doses of TIV…
BACKGROUND: The emergence of pandemic H1N1 influenza virus in early 2009 prompted the rapid licensure and use of H1N1 monovalent inactivated (MIV) and live, attenuated (LAMV) vaccines separate from seasonal trivalent inactivated (TIV) and live, attenuated (LAIV) influenza vaccines. A…
OBJECTIVES: To determine if giving vaccine-information materials before the 2-month vaccination visit to mothers with concerns about vaccine safety positively changed their attitudes and beliefs about vaccine safety. METHODS: Mothers who indicated concerns about infant vaccinations were recruited from 2…
The Vaccine Safety Datalink (VSD) project is a collaborative project between the Centers for Disease Control and Prevention and 8 managed care organizations (MCOs) in the United States. Established in 1990 to conduct postmarketing evaluations of vaccine safety, the project…
The Clinical Immunization Safety Assessment (CISA) Network is a collaboration between the Centers for Disease Control and Prevention (CDC) and 6 academic medical centers to provide support for immunization safety assessment and research. The CISA Network was established by the…
OBJECTIVE: To describe the Vaccine Safety Datalink (VSD) project's experience with population-based, active surveillance for vaccine safety and draw lessons that may be useful for similar efforts. PATIENTS AND METHODS: The VSD comprises a population of 9.2 million people annually…
BACKGROUND: Children with inherited metabolic disorders are a potential high-risk group for vaccine-preventable diseases, yet information regarding immunization rates and vaccine safety within this population is limited. METHODS: Using Northern California Kaiser Permanente's electronic medical record, we identified children with…
BACKGROUND: Streptococcus pneumoniae continues to cause a variety of common clinical syndromes; despite vaccination programs for both adults and children. The total U.S. burden of pneumococcal disease is unknown. METHODS: We constructed a decision tree-based model to estimate U.S. healthcare…
Studies evaluating the safety of vaccines routinely administered to a population of healthy infants and children may not provide adequate reassurance for members of special populations such as premature infants and children with chronic conditions. However, evaluating the safety of…
BACKGROUND: Routine administration of quadrivalent meningococcal conjugate vaccine to adolescents and certain high risk groups is recommended in the United States and Canada. We compared the immunogenicity and safety of an investigational quadrivalent meningococcal vaccine conjugated to CRM-197 (MenACWY-CRM) with…
OBJECTIVE: To estimate influenza vaccine effectiveness (VE) in preventing hospitalizations in persons over 50 years of age. DESIGN: We performed a retrospective, population based study, using a 'difference-in-differences' approach to determine the association between hospitalization and prior vaccination. We examined…
OBJECTIVE: Exposure to thimerosal, a mercury-containing preservative that is used in vaccines and immunoglobulin preparations, has been hypothesized to be associated with increased risk of autism spectrum disorder (ASD). This study was designed to examine relationships between prenatal and infant…
BACKGROUND: This study (NCT00383123) compared the immunogenicity and safety of 2 trivalent inactivated influenza vaccines: Fluarix [GlaxoSmithKline (study vaccine)] and Fluzone [Sanofi Pasteur (control vaccine)] in children 6 months to
Influenza is a common and potentially serious infection in infants. Previous studies of influenza vaccine in this age group have reported widely varying estimates of vaccine effectiveness, and few have used laboratory confirmation of influenza diagnoses. We evaluated the effectiveness…
OBJECTIVE: Premature infants can experience cardiorespiratory events such as apnea after immunization in the neonatal intensive care unit (NICU). These changes in clinical status may precipitate sepsis evaluations. This study evaluated whether sepsis evaluations are increased after immunizations in the…
OBJECTIVES: Receipt of diphtheria-tetanus-whole-cell pertussis vaccine (diphtheria-tetanus toxoids-pertussis [DTP]) is associated with seizures. Limited population-based studies have been conducted on the risk for seizures after receipt of diphtheria-tetanus-acellular pertussis vaccine (diphtheria-tetanus-acellular pertussis [DTaP]). METHODS: We conducted a retrospective study from…
OBJECTIVE: In February 2008, we alerted the Advisory Committee on Immunization Practices to preliminary evidence of a twofold increased risk of febrile seizures after the combination measles-mumps-rubella-varicella (MMRV) vaccine when compared with separate measles-mumps-rubella (MMR) and varicella vaccines. Now with…
BACKGROUND: Prelicensure clinical studies may not include sufficient numbers of subjects to assess the potential for rare postvaccination adverse events. The aim of this postlicensure study (NCT00297856) was to evaluate uncommon outcomes following vaccination with a tetanus, reduced-antigen-content diphtheria, and…
CONTEXT: Multiple studies have shown that preventing influenza by vaccination reduces the risk of vascular events. However, the effect of pneumococcal polysaccharide vaccine on vascular events remains controversial. OBJECTIVE: To examine the association between pneumococcal vaccination and risk of acute…
Safety monitoring following new vaccine introduction includes assessment of potential new onset autoimmune diseases (AID). As knowledge regarding AID background rates is limited, we evaluated the incidence of 11 AID in Northern California Kaiser Permanente. AID cases were identified using…
The emergence of pandemic H1N1 influenza in 2009 has prompted public health responses, including production and licensure of new influenza A (H1N1) 2009 monovalent vaccines. Safety monitoring is a critical component of vaccination programs. As proof-of-concept, the authors mimicked near…
Although studies have shown influenza vaccines to be effective in preventing death in the elderly population, these findings may be the result of selection bias. We examined the relationship between vaccination, age, underlying morbidity, and probability of death in the…
BACKGROUND: The antigen-specific T cell responses of preterm infants to immunization are not well understood. The aim of the present study was to compare the T cell responses of preterm infants after inactivated poliovirus vaccination with those of term infants.…
Meningococcal disease incidence is highest in infants, but a significant burden of disease also occurs in children. In this Phase II, single-centre US study, 619 healthy children (2-10 years of age) received one dose of an investigational quadrivalent meningococcal CRM(197)-conjugated…
BACKGROUND: A pentavalent, bovine-derived rotavirus vaccine (RotaTeq, Merck) was licensed in 2006 for use in infants. A previously licensed rotavirus vaccine was withdrawn due to elevated risk of intussusception. We prospectively evaluated the risk of intussusception and other pre-specified adverse…
We compared the response to a new vaccine information pamphlet with the current CDC Vaccine Information Statements (VIS) among recently delivered mothers who were screened to identify those with concerns about immunization. Eligible mothers (n=226) were randomly assigned to one…
Seven-valent pneumococcal conjugate vaccine (PCV7) has been in routine use in the United States since 2000 and data have indicated direct and indirect effects of the vaccine. We simulated the effects of PCV7 on children vaccinated during 2000-2006, incorporating direct…
OBJECTIVES: We studied compliance with multiple-dose vaccine schedules, assessed factors associated with noncompliance, and examined timeliness of series completion among older children, adolescents, and adults. METHODS: We conducted a large, multisite, retrospective cohort study of older children, adolescents, and adults…
It is widely believed that influenza (flu) vaccination of the elderly reduces all-cause mortality, yet randomized trials for assessing vaccine effectiveness are not feasible and the observational research has been controversial. Efforts to differentiate vaccine effectiveness from selection bias have…
Using a probabilistic model of the clinical and economic burden of rotavirus gastroenteritis (RVGE), we estimated the expected impact of vaccinating a US birth cohort with Rotarix in lieu of RotaTeq. Assuming full vaccination of all children, use of Rotarix…
OBJECTIVE: New vaccines that offer protection against otitis media caused by nontypeable Haemophilus influenzae and by Moraxella catarrhalis are under development. However, the potential health benefits and economic effects of such candidate vaccines have not been systematically assessed. METHODS: We…
BACKGROUND: Ischemic stroke is a known complication of varicella disease. Although there have been case reports of ischemic stroke after varicella vaccination, the existence and magnitude of any vaccine-associated risk has not been determined. OBJECTIVE. The purpose of this work…
Abscess formation following immunisation is a previously reported complication, generally associated with microbial contamination of the vaccine. Less commonly, such abscesses have been sterile. Here we describe two children evaluated in the Center for Disease Control and Prevention (CDC)-funded Clinical…
Combination vaccines allow the administration of multiple vaccine antigens without the need for multiple injections. Recently, a combined diphtheria toxoid, tetanus toxoid, acellular pertussis and inactivated poliomyelitis vaccine (DTaP-IPV), Kinrix, has been licensed in the USA for use as the…
The pneumococcal conjugate vaccine (PCV) is the first vaccine proven to be effective in reducing the incidence of invasive pneumococcal disease, pneumonia and acute otitis media in children, and has been recommended for universal use in children in a number…
BACKGROUND: In the United States, diphtheria-tetanus-acellular pertussis (DTaP) and inactivated poliovirus (IPV) booster vaccinations are recommended for children 4-6 years of age. A combined DTaP-IPV vaccine is being developed, which would reduce by one the number of injections in this…
OBJECTIVES: Among hospitalized NICU infants, preimmunization apnea is a well-recognized predictor of postimmunization apnea. However, predictors for postimmunization apnea among NICU infants without preimmunization apnea have not been investigated. METHODS: Using a large NICU database in the Northern California Kaiser…
OBJECTIVES: The US Advisory Committee on Immunization Practices has recently recommended a new vaccine against herpes zoster (shingles) for routine use in adults aged or =60 years. However, estimates of the cost effectiveness of this vaccine vary widely, in part…
BACKGROUND: National and state surveys show large disparities in pneumococcal vaccination status among Whites, Blacks and Latinos aged >/= 65. The purpose of this study is to determine whether there is any difference in the validity of self-report for pneumococcal…
BACKGROUND: Rare but serious adverse events associated with vaccines or drugs are often nearly impossible to detect in prelicensure studies and require monitoring after introduction of the agent in large populations. Sequential testing procedures are needed to detect vaccine or…
OBJECTIVES: To assess the incidence of invasive pneumococcal disease (IPD) in all children younger than 5 years of age in the Northern California Kaiser Permanente (NCKP) health care system during a 5-year surveillance period (2000-2005) after the introduction in April…
BACKGROUND: A wide range in antibody titers has been found after immunization with the varicella vaccine, although the basis for these differences has not been described. METHODS: To evaluate the contribution of a genetic component in the immune response to…
BACKGROUND: A World Health Organization (WHO) working group in 2001 developed a method for standardizing interpretation of chest radiographs in children for epidemiologic purposes. We reevaluated radiographs from the Kaiser Permanente Pneumococcal Efficacy trial using this method. METHODS: Seven-valent pneumococcal…
BACKGROUND: Pneumococcal conjugate vaccine (PCV) has been in routine use in the United States for 5 years. Prior U.S. cost-effectiveness analyses have not taken into account the effect of the vaccine on nonvaccinated persons. METHODS: We revised a previously published…
Pneumococcal conjugate vaccine was introduced for routine use in infants and toddlers in the United States in March 2000. We report on the impact of the introduction of this vaccine on disease epidemiology in young children as well as secondary…
The Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention recommends influenza vaccination for women who will be in the second or third trimester of pregnancy during the influenza season. We analyzed hospital admissions with principal…
OBJECTIVE: To assess the direct and indirect effects of the introduction of routine use of pneumococcal conjugate vaccine in infants and toddlers at risk for invasive disease caused by vaccine serotypes and nonvaccine serotypes in vaccinated children and unvaccinated children…
CONTEXT: The heptavalent pneumococcal conjugate vaccine (PCV) is recommended for infants to protect against invasive disease, but its impact on otitis might also have public health importance. OBJECTIVE: To examine the impact of PCV on the incidence of otitis media,…
OBJECTIVE: To determine the effectiveness of the Wyeth heptavalent pneumococcal conjugate vaccine against clinical and radiograph-confirmed pneumonia in children. METHODS: The heptavalent CRM(197) pneumococcal conjugate vaccine (PCV) was given to infants at 2, 4, 6 and 12 to 15 months…
We evaluated the effect of infant vaccination with HbOC Haemophilus influenzae type b (Hib) conjugate vaccine on the risk of onset of type 1 juvenile diabetes later in life by examining data from a large controlled prospective Phase III clinical…
BACKGROUND: Pneumococcal conjugate vaccine for infants has recently been found to be effective for prevention of meningitis, bacteremia, pneumonia and otitis media, but it is more costly than previously introduced vaccines. AIM: We sought to determine the savings in medical…
OBJECTIVE: To determine the efficacy, immunogenicity and safety of the heptavalent CRM197 pneumococcal conjugate vaccine (PCV) in low birth weight (LBW) and preterm (PT) infants against invasive pneumococcal disease caused by vaccine types. METHODS: In a randomized double blind trial…
BACKGROUND: In patients with decreased resistance to infection, Staphylococcus aureus is a major cause of bacteremia and its complications. The capsular polysaccharides are essential for the pathogenesis of and immunity to S. aureus infection and are targets for vaccines. METHODS:…
OBJECTIVE: In January 1997, one of the most significant changes to United States vaccine policy occurred when polio immunization guidelines changed to recommend a schedule containing inactivated polio vaccine (IPV). There were concerns that parent or physician reluctance to accept…
OBJECTIVES: To describe variation in clinician recommendations for multiple injections during the adoption of inactivated poliovirus vaccine (IPV) in 2 large health maintenance organizations (HMOs), and to test the hypothesis that variation in recommendations would be associated with variation in…
Combination vaccines to minimize injections required for infant vaccination, and new vaccines with improved safety profiles, will pose increasingly complex choices for vaccine purchasers in the future. How much of a premium to pay for such vaccines might be determined…
CONTEXT: Pneumococcal conjugate vaccine for infants has recently been found effective against meningitis, bacteremia, pneumonia, and otitis media. OBJECTIVE: To evaluate the projected health and economic impact of pneumococcal conjugate vaccination of healthy US infants and young children. DESIGN: Cost-effectiveness…
OBJECTIVES: The objectives of this study were (1) to determine the safety and immunogenicity of heptavalent pneumococcal CRM197 conjugate (PNCRM7) vaccine in infants and (2) to determine the effect of concurrent hepatitis B immunization during the primary series and the…
BACKGROUND: Immunization rates have improved in the United States, but are still far from the national 90% goal for the year 2000. There is scant evidence about the effectiveness and costs of automated telephone messages to improve immunization rates among…
BACKGROUND: Clinicians who offer varicella vaccination to school age children face the dilemma of whether to serotest or vaccinate presumptively. Varicella seroprevalence among 7- to 12-year-old children with negative or uncertain histories has not previously been studied. Our main objective…
The safety and immunogenicity of the HbOC conjugate vaccine have been evaluated in a study population of 61,080 children in the Kaiser Permanente Medical Care Program of Northern California. Half of the population served as controls. The vaccine was given…
The efficacy of the HbOC conjugate Haemophilus influenzae type b vaccine was evaluated in a study population of 61,080 infants in the Northern California Kaiser Permanente Medical Care Program. Between February, 1988, and June, 1990, the HbOC vaccine was given…
The efficacy of the Haemophilus influenzae type b (Hib) polyribose phosphate vaccine was evaluated in a population of 120,000 children from 23 through 71 months of age in the Kaiser Permanente Medical Care Program (KPMCP) in Northern California over the…
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