Jacobson, Karen B.
Research interests include mitigating sequelae of infectious diseases, particularly SARS-CoV-2.
Relative Vaccine Effectiveness of Adjuvanted Quadrivalent Inactivated Influenza Vaccine (aIIV4) vs High-Dose Quadrivalent Inactivated Influenza Vaccine (HD-IIV4) for Prevention of Lab-confirmed Influenza Medical Encounters
In this study, each objective will be evaluated for each season individually and in a combined analysis. The primary objective…
Safety of tetanus, diphtheria, acellular pertussis with 5 acellular pertussis components (Tdap5, Adacel) vaccination during pregnancy
The primary objective of this study is to further evaluate the safety of Adacel vaccine among pregnant individuals exposed to…
Effectiveness of BNT162b2 COVID-19 Vaccination in Children and Adolescents
We assessed BNT162b2 vaccine effectiveness (VE) against mild to moderate and severe coronavirus disease 2019 (COVID-19) in children and adolescents…
Immunogenicity and Safety of a Third COVID-19 BNT162b2 mRNA Vaccine Dose in 5-11-Year-Olds
In this ongoing study, substantially increased ancestral SARS-CoV-2 neutralizing responses were observed 1 month after a third 10-µg BNT162b2 dose…
Protection of 2 and 3 mRNA Vaccine Doses Against Severe Outcomes Among Adults Hospitalized with COVID-19 – VISION Network, August 2021 – March 2022
We assessed coronavirus disease 2019 (COVID-19) vaccination impact on illness severity among adults hospitalized with COVID-19, August 2021-March 2022. We…
Safety of measles, mumps, and rubella vaccine in adolescents and adults in the vaccine safety Datalink
Measles, mumps, and rubella vaccine (MMR) is routinely administered to children; however, adolescents and adults may receive MMR for various…
Early Estimates of Bivalent mRNA Vaccine Effectiveness in Preventing COVID-19-Associated Emergency Department or Urgent Care Encounters and Hospitalizations Among Immunocompetent Adults – VISION Network, Nine States, September-November 2022
During June-October 2022, the SARS-CoV-2 Omicron BA.5 sublineage accounted for most of the sequenced viral genomes in the United States,…
COVID-19 Vaccine Safety Surveillance in Early Pregnancy in the United States: Design Factors Affecting the Association Between Vaccine and Spontaneous Abortion
In the Vaccine Safety Datalink (VSD), we previously reported no association between COVID-19 vaccination in early pregnancy and spontaneous abortion…
Safety of 9-valent human papillomavirus vaccine administered to males and females in routine use
The nine-valent human papillomavirus vaccine (HPV9, Gardasil®9) was licensed in the USA in December 2014. This study was a multiyear…
Estimation of COVID-19 mRNA Vaccine Effectiveness and COVID-19 Illness and Severity by Vaccination Status During Omicron BA.4 and BA.5 Sublineage Periods
Recent SARS-CoV-2 Omicron variant sublineages, including BA.4 and BA.5, may be associated with greater immune evasion and less protection against…
Maternal SARS-CoV-2 vaccination and infant protection against SARS-CoV-2 during the first six months of life
We examined the effectiveness of maternal vaccination against SARS-CoV-2 infection in 30,311 infants born at Kaiser Permanente Northern California from…
Active Post-Licensure Safety Surveillance for Recombinant Zoster Vaccine Using Electronic Health Record Data
Recombinant zoster vaccine (RZV) (Shingrix; GlaxoSmithKline, Brentford, United Kingdom) is an adjuvanted glycoprotein vaccine that was licensed in 2017 to…
Vaccine effectiveness against influenza-associated urgent care, emergency department, and hospital encounters during the 2021-2022 season, VISION Network
Following historically low influenza activity during the 2020-2021 season, the United States saw an increase in influenza circulating during the…
A safety study evaluating non-COVID-19 mortality risk following COVID-19 vaccination
The safety of COVID-19 vaccines plays an important role in addressing vaccine hesitancy. We conducted a large cohort study to…
Characterization of parental intention to vaccinate elementary school aged children in the state of California
In October 2021, Emergency Use Authorization of Coronavirus Disease 2019 (COVID-19) vaccines was granted for children aged 5-11. To ensure…
Association Between Aluminum Exposure From Vaccines Before Age 24 Months and Persistent Asthma at Age 24 to 59 Months
To assess the association between cumulative aluminum exposure from vaccines before age 24 months and persistent asthma at age 24…
Extended surveillance to assess safety of 9-valent human papillomavirus vaccine
The safety of 9-valent HPV vaccine (9vHPV) has been established with regard to common and uncommon adverse events. However, investigation…
Early Estimates of Bivalent mRNA Vaccine Effectiveness in Preventing COVID-19-Associated Emergency Department or Urgent Care Encounters and Hospitalizations Among Immunocompetent Adults – VISION Network, Nine States, September-November 2022
During June-October 2022, the SARS-CoV-2 Omicron BA.5 sublineage accounted for most of the sequenced viral genomes in the United States,…
Kawasaki Disease Following the 13-valent Pneumococcal Conjugate Vaccine and Rotavirus Vaccines
Temporal associations between Kawasaki disease (KD) and childhood vaccines have been reported. Limited data on KD following 13-valent pneumococcal conjugate…
Zerbo, Ousseny
Research interests include autism
Klein, Nicola P.
Research interests include vaccine safety and efficacy.
A Phase IIIB, Randomized, Observer-blind, Multicenter Study to Assess the Safety and lmmunogenicity of GSK Meningococcal Group B Vaccine when Administered Concomitantly with GSK Meningococcal MenACWY Conjugate Vaccine to Healthy Subjects 16-18
This study will assess the safety and tolerability of rMenB+OMV NZ and MenACWY vaccines when administered concomitantly or alone in…
Pediatric COVID-19 Vaccination RCT in Young Children
We are providing technical expertise, consultation, and enrolling participants in a randomized clinical trial to evaluate the safety of simultaneous…
VSD Infrastructure
We conduct administrative tasks, data management, and contribute to vaccine safety assessments to support the management and development of the…
Effectiveness of COVID-19 mRNA Vaccines Against COVID-19-Associated Hospitalizations Among Immunocompromised Adults During SARS-CoV-2 Omicron Predominance – VISION Network, 10 States, December 2021-August 2022
Persons with moderate-to-severe immunocompromising conditions might have reduced protection after COVID-19 vaccination, compared with persons without immunocompromising conditions (1-3). On…
Maternal SARS-CoV-2 Vaccination and Infant Protection Against SARS-CoV-2 During the First 6 Months of Life
We examined the effectiveness of maternal vaccination against SARS-CoV-2 infection in 30,288 infants born at Kaiser Permanente Northern California from…
Waning of vaccine effectiveness against moderate and severe covid-19 among adults in the US from the VISION network: test negative, case-control study
To estimate the effectiveness of mRNA vaccines against moderate and severe covid-19 in adults by time since second, third, or…
Estimation of COVID-19 mRNA Vaccine Effectiveness Against Medically Attended COVID-19 in Pregnancy During Periods of Delta and Omicron Variant Predominance in the United States
Pregnant people are at high risk for severe COVID-19 but were excluded from mRNA vaccine trials; data on COVID-19 vaccine…
Risk of myocarditis and pericarditis following BNT162b2 and mRNA-1273 COVID-19 vaccination
Evidence indicates that mRNA COVID-19 vaccination is associated with risk of myocarditis and possibly pericarditis, especially in young males. It…
Effectiveness of Adacel Vaccination in Pregnancy in Preventing Infant Pertussis
This observational cohort study will determine the effectiveness of the Adacel vaccine against pertussis disease in infants aged 2 months…
Adults hospitalized with breakthrough COVID-19 have lower mortality than matched unvaccinated adults
Coronavirus disease 2019 (COVID-19) breakthrough infections are common. Evaluate in-hospital mortality of patients with COVID-19 by vaccination status using retrospective…
Effectiveness of 2, 3, and 4 COVID-19 mRNA Vaccine Doses Among Immunocompetent Adults During Periods when SARS-CoV-2 Omicron BA.1 and BA.2/BA.2.12.1 Sublineages Predominated – VISION Network, 10 States, December 2021-June 2022
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…
Lessons from a mature acellular pertussis vaccination program and strategies to overcome suboptimal vaccine effectiveness
Despite high vaccination coverage among children and adolescents, pertussis remains a public health problem, with large outbreaks occurring periodically in…
Effect of Electronic and Mail Outreach From Primary Care Physicians for COVID-19 Vaccination of Black and Latino Older Adults: A Randomized Clinical Trial
COVID-19 morbidity is highest in Black and Latino older adults. These racial and ethnic groups initially had lower vaccination uptake…
Changes in incidence rates of outcomes of interest in vaccine safety studies during the COVID-19 pandemic
The COVID-19 pandemic caused an abrupt drop in in-person health care (inpatient, Emergency Department, outpatient) and an increase in telehealth…
Safety and Efficacy of a Third Dose of BNT162b2 Covid-19 Vaccine
Active immunization with the BNT162b2 vaccine (Pfizer-BioNTech) has been a critical mitigation tool against severe acute respiratory syndrome coronavirus 2…
COVID-19 Vaccine Effectiveness in Pregnant Women and their Infants
The overall goals are to: Determine COVID-19 vaccine effectiveness in pregnant women for preventing laboratory-confirmed COVID-19 and hospitalization for COVID-19…
Incidence of Guillain-Barré Syndrome After COVID-19 Vaccination in the Vaccine Safety Datalink
Postauthorization monitoring of vaccines in a large population may detect rare adverse events not identified in clinical trials such as…
Effectiveness of Homologous and Heterologous COVID-19 Booster Doses Following 1 Ad.26.COV2.S (Janssen [Johnson & Johnson]) Vaccine Dose Against COVID-19-Associated Emergency Department and Urgent Care Encounters and Hospitalizations Among Adults – VISION Network, 10 States, December 2021-March 2022
CDC recommends that all persons aged ≥18 years receive a single COVID-19 vaccine booster dose ≥2 months after receipt of…
Effectiveness of COVID-19 Pfizer-BioNTech BNT162b2 mRNA Vaccination in Preventing COVID-19-Associated Emergency Department and Urgent Care Encounters and Hospitalizations Among Nonimmunocompromised Children and Adolescents Aged 5-17 Years – VISION Network, 10 States, April 2021-January 2022
The efficacy of the BNT162b2 (Pfizer-BioNTech) vaccine against laboratory-confirmed COVID-19 exceeded 90% in clinical trials that included children and adolescents…
Incidence and Estimated Vaccine Effectiveness Against Hospitalizations for All-Cause Pneumonia Among Older US Adults Who Were Vaccinated and Not Vaccinated With 13-Valent Pneumococcal Conjugate Vaccine
Following routine use of 13-valent pneumococcal conjugate vaccine (PCV13) in children in 2010, invasive pneumococcal disease rates have decreased substantially…
A decade of data: Adolescent vaccination in the vaccine safety datalink, 2007 through 2016
Between May 2005 and March 2007, three vaccines were recommended by the Advisory Committee on Immunization Practices for routine use…
Waning 2-Dose and 3-Dose Effectiveness of mRNA Vaccines Against COVID-19-Associated Emergency Department and Urgent Care Encounters and Hospitalizations Among Adults During Periods of Delta and Omicron Variant Predominance – VISION Network, 10 States, August 2021-January 2022
CDC recommends that all persons aged ≥12 years receive a booster dose of COVID-19 mRNA vaccine ≥5 months after completion…
Safety of recombinant quadrivalent influenza vaccine compared to inactivated influenza vaccine in Chinese adults: An observational study
Recombinant influenza vaccine (RIV) has been in use in US adults since 2013. This study evaluated the safety of quadrivalent…
Effectiveness of a Third Dose of mRNA Vaccines Against COVID-19-Associated Emergency Department and Urgent Care Encounters and Hospitalizations Among Adults During Periods of Delta and Omicron Variant Predominance – VISION Network, 10 States, August 2021-January 2022
Estimates of COVID-19 mRNA vaccine effectiveness (VE) have declined in recent months (1,2) because of waning vaccine induced immunity over…
Association of the COVID-19 Pandemic With Routine Childhood Vaccination Rates and Proportion Up to Date With Vaccinations Across 8 US Health Systems in the Vaccine Safety Datalink
The COVID-19 pandemic has affected routine vaccine delivery in the US and globally. The magnitude of these disruptions and their…
A multi-country investigation of influenza vaccine coverage in pregnant individuals, 2010-2016
Many countries recommend influenza vaccination during pregnancy. Despite this recommendation, influenza vaccine among pregnant individuals remains under-utilized and uptake varies…
Laboratory-Confirmed COVID-19 Among Adults Hospitalized with COVID-19-Like Illness with Infection-Induced or mRNA Vaccine-Induced SARS-CoV-2 Immunity – Nine States, January-September 2021
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…
Effectiveness of 2-Dose Vaccination with mRNA COVID-19 Vaccines Against COVID-19-Associated Hospitalizations Among Immunocompromised Adults – Nine States, January-September 2021
Immunocompromised persons, defined as those with suppressed humoral or cellular immunity resulting from health conditions or medications, account for approximately…
Analysis to evaluate the effectiveness of a serogroup B outer membrane vesicle meningococcal vaccine against gonorrhea
The goal of this study is to use electronic medical records from 2016 to 2020 to evaluate the protective effect…
The Adjuvanted Recombinant Zoster Vaccine in Adults Aged ≥65 Years Previously Vaccinated With a Live-Attenuated Herpes Zoster Vaccine
Efficacy of the live-attenuated herpes zoster (HZ) vaccine (ZVL) wanes substantially over time. We evaluated immunogenicity and safety of the…
Effectiveness of Covid-19 Vaccines in Ambulatory and Inpatient Care Settings
There are limited data on the effectiveness of the vaccines against symptomatic coronavirus disease 2019 (Covid-19) currently authorized in the…
Interim Estimates of COVID-19 Vaccine Effectiveness Against COVID-19-Associated Emergency Department or Urgent Care Clinic Encounters and Hospitalizations Among Adults During SARS-CoV-2 B.1.617.2 (Delta) Variant Predominance – Nine States, June-August 2021
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…
A phase 3, randomized, double-blind study to evaluate the immunogenicity and safety of 3 lots of 20-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naive adults 18 through 49 years of age
Introduction of pneumococcal conjugate vaccines (PCVs), including the 13-valent PCV (PCV13), has considerably reduced pneumococcal disease burden. However, additional serotypes…
Use of COVID-19 Vaccines After Reports of Adverse Events Among Adult Recipients of Janssen (Johnson & Johnson) and mRNA COVID-19 Vaccines (Pfizer-BioNTech and Moderna): Update from the Advisory Committee on Immunization Practices – United States, July 2021
In December 2020, the Food and Drug Administration (FDA) issued Emergency Use Authorizations (EUAs) for Pfizer-BioNTech and Moderna COVID-19 vaccines,…
Long-term Outcomes Associated with Extended-Interval Dosing of the 9vHPV Vaccine: a Prospective, Observational Cohort Study Supplementary to V503-069 Clinical Trial
This prospective, observational cohort study, an extension of clinical trial V503-069, will enroll and administer a second dose of 9vHPV…
A Phase 3 International, Multicenter, Open-label Study to Evaluate the Safety and Immunogenicity of 9vHPV Vaccine Administered as 2-dose Regimen with Extended Dosing Intervals in 9- to 14-Year-Old Boys and Girls Compared with a Standard 3-dose
This study will evaluate extended 2-dose regimens in boys and girls ages 10 to 15 who previously received 1 dose…
A Phase 1, Open-Label Dose-Finding Study to Evaluate Safety, Tolerability, and Immunogenicity Study of a Sars-Cov-2 RNA Vaccine Candidate Against Covid-19 in Healthy Children 12 Years of Age
This phase I open-label dose-finding study will evaluate the safety, tolerability, and immunogenicity of a Sars-Cov-2 RNA vaccine candidate against…
Safety, Immunogenicity, and Efficacy of the BNT162b2 Covid-19 Vaccine in Adolescents
Until very recently, vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) had not been authorized for emergency use in…
School-level perceptions and enforcement of the elimination of nonmedical exemptions to vaccination in California
In 2015, California passed Senate Bill 277 eliminating all nonmedical exemptions to school vaccinations. We aimed to explore school-level modes…
Incidence of pediatric inflammatory bowel disease within the Vaccine Safety Datalink network and evaluation of association with rotavirus vaccination
Recent studies have reported an increase in Inflammatory bowel disease (IBD) incidence in young children, highlighting the need to better…
Genetic associations with a fever after measles-containing vaccines
Children have elevated fever risk 1 to 2 weeks after the first dose of a measles-containing vaccine (MCV), which is likely…
Parental vaccine attitudes, beliefs, and practices: initial evidence in California after a vaccine policy change
Senate Bill 277 (SB277) eliminated nonmedical exemptions for school-entry vaccines in California, but the impact of parental vaccine knowledge, attitudes,…
Genome Sequencing Study, Flublock Quadrivalent Vaccine
Study will perform sequencing on 300 specimens from a mixture of Flublok Quadrivalent vaccine recipients, SD-IIV4 recipients, and unvaccinated individuals;…
COVID-19 Infrastructure and Activities Vaccine Safety Datalink Project
This work will support and contribute to the COVID-19 vaccine safety work of the VSD: managing site contributions, and participating…
Phase 3 Study to Evaluate the Safety and Immunogenicity of 9vHPV Vaccine in 9- to 14-Year Old Boys and Girls
This study will evaluate extended 2-dose regimens in 2 different populations: (1) boys and girls 10 to 15 years of…
Association of Inadvertent 9-Valent Human Papillomavirus Vaccine in Pregnancy With Spontaneous Abortion and Adverse Birth Outcomes
The 9-valent human papillomavirus (9vHPV) vaccine is recommended for individuals through age 26 years and may be administered to women…
Studying attitudes towards vaccine hesitance and California law SB 277 in online discourse: A dataset and methodology
This article presents data that are further analyzed and interpreted in "Shouting at Each Other into the Void: A Semantic…
Concomitant administration of a liquid formulation of human rotavirus vaccine (porcine circovirus-free) with routine childhood vaccines in infants in the United States: Results from a phase 3, randomized trial
In response to the detection of porcine circovirus type 1 (PCV-1) in the human rotavirus vaccine (HRV), a PCV-free HRV…
Rapid Cycle Analysis for COVID-19 Vaccines in Vaccine Safety Datalink
We will develop a protocol, coordinate, and lead Rapid Cycle Analysis (RCA) activities in order to monitor the safety of…
A Phase 3, Randomized, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a 20-Valent Pneumococcal Conjugate Vaccine in Healthy Infants
This study is part of the Phase 3 pediatric clinical development program to evaluate the 20-Valent Pneumococcal Conjugate Vaccine for…
Vaccine Safety Datalink infrastructure enhancements for evaluating the safety of maternal vaccination
Identifying pregnancy episodes and accurately estimating their beginning and end dates are imperative for observational maternal vaccine safety studies using…
Evaluating the Association of Stillbirths After Maternal Vaccination in the Vaccine Safety Datalink
To evaluate whether the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices recommended influenza and tetanus toxoid,…
Shouting at each other into the void: A linguistic network analysis of vaccine hesitance and support in online discourse regarding California law SB277
In 2015, California passed Senate Bill 277 and became the third state in the United States to ban all nonmedical…
Identification and description of mumps cases in a non-outbreak setting and evaluation of the effectiveness of mumps-containing vaccines over time
Mumps outbreaks among previously vaccinated young adults raise concerns regarding waning vaccine immunity. This study identified, described and assessed the…
Individual and Neighborhood Factors Associated with Failure to Vaccinate against Influenza during Pregnancy
Uptake of influenza vaccine among pregnant women remains low. We investigated whether unvaccinated pregnant women were clustered geographically and determined…
A Phase 1/2/3, Placebo-controlled, Randomized, Observer-blind, Dose-finding Study to Describe the Safety, Tolerability, Immunogenicity, and Potential Efficacy of SARS-Co V-2 RNA Vaccine Candidates Against COVID-19 in Healthy Adults
To describe the safety and tolerability profiles of prophylactic BNT162 vaccines in healthy adults after 1 or 2 doses
Determining Which of Several Simultaneously Administered Vaccines Increase Risk of an Adverse Event
Childhood immunization schedules often involve multiple vaccinations per visit. When increased risk of an adverse event is observed after simultaneous…
Evaluation of a Vaccine-Communication Tool for Physicians
To evaluate a Kaiser Permanente Northern California physician training tool entitled "Effective Communication without Confrontation" aimed at improving communication with…
Overcoming Waning Immunity in Pertussis Vaccines: Workshop of the National Institute of Allergy and Infectious Diseases
Despite high vaccine coverage in many parts of the world, pertussis is resurging in a number of areas in which…
Innovative Methods to Inform Estimates of Vaccine Effectiveness Using Information on the Epidemiology and Incidence of Influenza and Other Acute Respiratory Illnesses
This study will estimate influenza vaccine effectiveness by vaccine type and for different ages by combining data from medical records,…
Safety of Recombinant Influenza Vaccine Compared to Inactivated Influenza Vaccine in Adults: An Observational Study
Recombinant trivalent influenza vaccine (RIV3) was initially licensed in 2013 and approved for all adults ≥18 in 2014. This study evaluated…
Impact of the 13-Valent Pneumococcal Conjugate Vaccine on Invasive Pneumococcal Disease After Introduction Into Routine Pediatric Use
In 2010, the 13-valent pneumococcal conjugate vaccine (PCV13) replaced 7-valent PCV (PCV7) for protection against invasive pneumococcal disease (IPD). This…
Immunogenicity and Safety of a Measles-Mumps-Rubella Vaccine Administered as a First Dose to Children Aged 12 to 15 Months: A Phase III, Randomized, Noninferiority, Lot-to-Lot Consistency Study
MMR II (M-M-R II [Merck & Co, Inc.]) is currently the only measles, mumps, and rubella (MMR) vaccine licensed in…
Parental Risk Factors for Fever in their Children 7-10 Days After the First Dose of Measles-Containing Vaccines
We evaluated whether parental clinical conditions were associated with fever after a first dose of measles-containing vaccine (MCV) in the…
Depletion of Susceptibles Bias in Analyses of Intra-season Waning of Influenza Vaccine Effectiveness
Bias arises in studies of waning vaccine effectiveness when higher-risk individuals are depleted from the at-risk population at different rates…
Human Papillomavirus Vaccine Effectiveness Against HPV Infection: Evaluation of One, Two, and Three Doses
Highly effective human papillomavirus (HPV) vaccines are used in many national programs in 3- or 2-dose schedules. We examined HPV…
Order of Live and Inactivated Vaccines and Risk of Non-vaccine-targeted Infections in US Children 11-23 Months of Age
Some findings from observational studies have suggested that recent receipt of live vaccines may be associated with decreased non-vaccine-targeted infection…
Trivalent inactivated influenza vaccine (IIV3) during pregnancy and six-month infant development
Despite recommendations by professional organizations that all pregnant women receive inactivated influenza vaccine, safety concerns remain a barrier. Our objective…
Survey of influenza vaccine knowledge, attitudes, and beliefs among pregnant women in the 2016-17 season
Influenza vaccination coverage among pregnant women in the United States is suboptimal. We surveyed women who were pregnant during the…
Homeschooling parents in California: Attitudes, beliefs and behaviors associated with child’s vaccination status
Senate Bill 277 (SB277) banned nonmedical exemptions from school-entry vaccination requirements for children attending classroom-based schools in California, but excluded…
Background rates of maternal, fetal, neonatal, and infant outcomes and events of interest to inform maternal immunization clinical trials
GlaxoSmithKline Vaccines is currently preparing for clinical trials that evaluate the safety/reactogenicity and immunogenicity of a respiratory syncytial virus maternal…
Vaccine effectiveness of cell-culture relative to egg-based inactivated influenza vaccine during the 2017-18 influenza season
There is concern that influenza vaccine effectiveness (VE) may be attenuated by passage in eggs during manufacture. We compared quadrivalent…
Near Real-Time Surveillance to Assess the Safety of the 9-Valent Human Papillomavirus Vaccine
Human papillomavirus is the most common sexually transmitted infection in the United States and causes certain anogenital and oropharyngeal cancers.…
Uptake and safety of hepatitis A vaccination during pregnancy: A Vaccine Safety Datalink study
Infection with hepatitis A virus (HAV) during pregnancy, although uncommon, is associated with gestational complications and pre-term labor. Hepatitis A…
Inactivated influenza vaccine and spontaneous abortion in the Vaccine Safety Datalink in 2012-13, 2013-14, and 2014-15
A recent study reported an association between inactivated influenza vaccine (IIV) and spontaneous abortion (SAB), but only among women who…
Prevalence of human papillomavirus (HPV)-vaccine types by race/ethnicity and sociodemographic factors in women with high-grade cervical intraepithelial neoplasia (CIN2/3/AIS), Alameda County, California, United States
We evaluated racial/ethnic differences in prevalence of oncogenic HPV types targeted by the quadrivalent HPV vaccine (16/18) and nonavalent HPV…
Long-term effectiveness of zoster vaccine live for postherpetic neuralgia prevention
Postherpetic neuralgia (PHN) occurs in 5-30% of individuals with herpes zoster (HZ) and is characterized by long-lasting pain. Zoster vaccine…
Antibody persistence and booster response following MenACWY-CRM vaccination in children as assessed by two different assay methods
The quadrivalent meningococcal conjugate vaccine MenACWY-CRM has been shown to be immunogenic and well-tolerated in infants and toddlers. We evaluated…
The impact of reactogenicity after the first dose of recombinant zoster vaccine upon the physical functioning and quality of life of older adults: an open phase III trial
Herpes zoster and its related complications are associated with significant medical burden, which negatively affects quality of life and daily…
Associations of Statewide Legislative and Administrative Interventions With Vaccination Status Among Kindergartners in California
California implemented 3 interventions to increase uptake of vaccines. In 2014, Assembly bill 2109 tightened requirements for obtaining a personal…
Incidence of Herpes Zoster Among Children: 2003-2014
After the 1996 introduction of routine varicella vaccination in the United States, most studies evaluating pediatric herpes zoster (HZ) incidence…
Acellular Pertussis Vaccine Effectiveness Over Time
To determine pertussis risk by diphtheria-tetanus-acellular pertussis (DTaP) vaccination status and time since last DTaP dose. Children born at Kaiser…
Elimination of Nonmedical Immunization Exemptions in California and School-Entry Vaccine Status
California implemented Senate Bill 277 (SB277) in 2016, becoming the first state in nearly 30 years to eliminate nonmedical exemptions…
Vaccine safety in HIV-infected adults within the Vaccine Safety Datalink Project
We evaluate safety of routine vaccination among adults infected with human immunodeficiency virus (HIV) in five healthcare organizations in the…
Intra-season Waning of Influenza Vaccine Effectiveness
In the United States, it is recommended that healthcare providers offer influenza vaccination by October, if possible. However, if the…
Influenza Vaccine Effectiveness in Preventing Influenza-associated Hospitalizations During Pregnancy: A Multi-country Retrospective Test Negative Design Study, 2010-2016
To date, no study has examined influenza vaccine effectiveness (IVE) against laboratory-confirmed influenza-associated hospitalizations during pregnancy. The Pregnancy Influenza Vaccine…
Exploring California’s new law eliminating personal belief exemptions to childhood vaccines and vaccine decision-making among homeschooling mothers in California
California's Senate Bill 277 (SB-277) law eliminated the personal belief exemption to school immunization requirements. A potential consequence may be…
Estimating Vaccine Effectiveness Against Hospitalized Influenza During Pregnancy: Multicountry Protocol for a Retrospective Cohort Study
Although pregnant women are believed to have elevated risks of severe influenza infection and are targeted for influenza vaccination, no…
Similar relative risks of seizures following measles containing vaccination in children born preterm compared to full-term without previous seizures or seizure-related disorders
Febrile seizures are associated with the first dose of measles-containing vaccines and the risk increases with chronologic age during the…
Impact of an electronic medical record reminder on hepatitis B vaccine initiation and completion rates among insured adults with diabetes mellitus
The Advisory Committee on Immunization Practices recommends Hepatitis B (HepB) vaccine for previously unvaccinated adults
Evaluation of two frailty indices, with practical application in a vaccine clinical trial
Frail older adults are at increased risk of poor clinical outcomes. Frailty assessment is therefore important in clinical trials to…
Immunogenicity and safety following primary and booster vaccination with a hexavalent diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus and Haemophilus influenzae type b vaccine: a randomized trial in the United States
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…
Coadministration of 13-valent pneumococcal conjugate and quadrivalent inactivated influenza vaccines in adults previously immunized with polysaccharide pneumococcal vaccine 23: a randomized clinical trial
Immune responses to 13-valent pneumococcal conjugate vaccine (PCV13) and quadrivalent inactivated influenza vaccine (QIV) in older adults may vary with…
Immunogenicity and safety of the Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine co-administered with human rotavirus, hepatitis A and 13-valent pneumococcal conjugate vaccines: results from a phase III, randomized, multicenter study in infants
This phase III, open-label, randomized study (NCT01978093) evaluated the immunogenicity and safety of co-administered Haemophilus influenzae type b-Neisseria meningitidis serogroups…
Respiratory Syncytial Virus Hospitalization during Pregnancy in Four High-income Countries, 2010-2016
Few studies have addressed respiratory syncytial virus (RSV) infection during pregnancy. Among 846 pregnant women hospitalized with respiratory illness and…
A framework for research on vaccine effectiveness
The need for a systematic approach to research on vaccine effectiveness (VE) is increasing with growing numbers of vaccines and…
Uptake and safety of Hepatitis B vaccination during pregnancy: A Vaccine Safety Datalink study
Hepatitis B virus (HBV) infection acquired during pregnancy can pose a risk to the infant at birth that can lead…
Assessing Potential Confounding and Misclassification Bias When Studying the Safety of the Childhood Immunization Schedule
Some parents are concerned the childhood immunization schedule could increase risk for allergic disorders, including asthma. To inform future safety…
Effectiveness of catch-up human papillomavirus vaccination on incident cervical neoplasia in a US health-care setting: a population-based case-control study
The population effectiveness of human papillomavirus (HPV) catch-up vaccination, defined in the USA as first vaccination at ages 13-26 years,…
Safety of repeated doses of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine in adults and adolescents
In light of waning immunity to pertussis following receipt of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis (Tdap) vaccine,…
Pneumococcal Conjugate Vaccine Safety in Elderly Adults
The 13-valent pneumococcal conjugate vaccine (PCV13) and the 23-valent pneumococcal polysaccharide vaccine (PPSV23) were both recommended to adults aged ≥65…
Birth outcomes following immunization of pregnant women with pandemic H1N1 influenza vaccine 2009-2010
Following the H1N1 influenza pandemic in 2009, pregnant women were recommended to receive both seasonal (TIV) and H1N1 influenza vaccines.…
Vaccination Patterns in Children After Autism Spectrum Disorder Diagnosis and in Their Younger Siblings
In recent years, rates of vaccination have been declining. Whether this phenomenon disproportionately affects children with autism spectrum disorder (ASD)…
Live Attenuated Influenza Vaccination Prior To Age 3 Years and Subsequent Development of Asthma: A 14-Year Follow-Up Study
Live-attenuated influenza vaccines (LAIVs) are not licensed in children younger than 2 years of age because of a wheezing safety…
Immunogenicity and safety of the quadrivalent meningococcal ACWY-tetanus toxoid conjugate vaccine (MenACWY-TT) in splenectomized or hyposplenic children and adolescents: Results of a phase III, open, non-randomized study
Individuals with functional or anatomic asplenia are at high risk for meningococcal disease. We evaluated the immunogenicity and safety of…
Post-licensure safety surveillance study of routine use of quadrivalent meningococcal diphtheria toxoid conjugate vaccine (MenACWY-D) in infants and children
Menactra® vaccine (MenACWY-D) was licensed in the United States in 2005 for persons 11-55 years of age, in 2007 for children…
Meningococcal conjugate vaccine safety surveillance in the Vaccine Safety Datalink using a tree-temporal scan data mining method
The objective of our study was to conduct a data mining analysis to identify potential adverse events (AEs) following MENACWY-D…
Association Between Estimated Cumulative Vaccine Antigen Exposure Through the First 23 Months of Life and Non-Vaccine-Targeted Infections From 24 Through 47 Months of Age
Some parents are concerned that multiple vaccines in early childhood could weaken their child's immune system. Biological data suggest that…
Infant Hospitalizations and Mortality After Maternal Vaccination
The Advisory Committee on Immunization Practices currently recommends pregnant women receive influenza and tetanus toxoid, reduced diphtheria toxoid, and acellular…
Methods for addressing “innocent bystanders” when evaluating safety of concomitant vaccines
The need to develop methods for studying the safety of childhood immunization schedules has been recognized by the Institute of…
Postlicensure Safety Surveillance of Congenital Anomaly and Miscarriage Among Pregnancies Exposed to Quadrivalent Human Papillomavirus Vaccine
Limited safety data are available on inadvertent exposure to quadrivalent human papillomavirus vaccine (4vHPV) during pregnancy. We conducted a descriptive…
Bias from outcome misclassification in immunization schedule safety research
The Institute of Medicine recommended conducting observational studies of childhood immunization schedule safety. Such studies could be biased by outcome…
Effectiveness of Respiratory Syncytial Virus Immunoprophylaxis on Bronchiolitis Hospitalizations among High-risk Infants
We sought to determine the real-world effectiveness of respiratory syncytial virus (RSV) immunoprophylaxis in a population-based cohort to inform policy.…
Long-Term Effectiveness of the Live Zoster Vaccine in Preventing Shingles: A Cohort Study
A live attenuated zoster vaccine was licensed in the United States in 2006 for prevention of shingles in persons aged…
The safety of live attenuated influenza vaccine in children and adolescents 2 through 17years of age: A Vaccine Safety Datalink study
To evaluate the safety of live attenuated influenza vaccine (LAIV) in children 2 through 17 years of age. The study was…
Patterns of childhood immunization and all-cause mortality
Evidence supports the safety of the recommended childhood immunization schedule as a whole. However, additional research is warranted as parents'…
Use of acellular pertussis vaccines in the United States: can we do better?
Despite robust vaccination schedules and high vaccination rates, many countries, including the U.S., have seen large pertussis outbreaks with a…
Risk of venous thromboembolism following influenza vaccination in adults aged 50years and older in the Vaccine Safety Datalink
Influenza-like illness and inflammation are known risk factors for venous thromboembolism (VTE), which includes deep vein thrombosis (DVT) and pulmonary…
Association of spontaneous abortion with receipt of inactivated influenza vaccine containing H1N1pdm09 in 2010-11 and 2011-12
Inactivated influenza vaccine is recommended in any stage of pregnancy, but evidence of safety in early pregnancy is limited, including…
Post-licensure safety surveillance study of routine use of quadrivalent meningococcal diphtheria toxoid conjugate vaccine
Menactra� vaccine (MenACWY-D) was licensed in the United States in 2005 for persons 11-55years of age. The aim of this…
Rates and Predictors of Vaccinations Among Inflammatory Bowel Disease Patients Receiving Anti-Tumor Necrosis Factor Agents
As an important quality measure, the rates of recommended immunizations among immunocompromised inflammatory bowel disease (IBD) patients in community practice…
Lot-to-lot consistency, safety and immunogenicity of 3 lots of Haemophilus influenzae type b conjugate vaccine: results from a phase III randomized, multicenter study in infants
Vaccination against Haemophilus influenzae type b (Hib) is included in routine pediatric immunization schedule in the United States. Previous vaccine…
Waning protection following 5 doses of a 3-component diphtheria, tetanus, and acellular pertussis vaccine
The effectiveness of diphtheria, tetanus, and acellular pertussis (DTaP) vaccines wanes substantially after the 5thdose given at ages 4-6years, but…
No association between influenza vaccination during pregnancy and adverse birth outcomes
Pregnant women are recommended to receive inactivated influenza vaccination anytime during pregnancy. Studies have investigated the impact of influenza vaccination…
Asthma exacerbations among asthmatic children receiving live attenuated versus inactivated influenza vaccines
To investigate whether there is a difference in the risk of asthma exacerbations between children with pre-existing asthma who receive…
Effectiveness of Vaccination During Pregnancy to Prevent Infant Pertussis
Vaccination against pertussis during pregnancy is recommended to protect newborns, yet there is limited information about the effectiveness of maternal…
Assessing misclassification of vaccination status: Implications for studies of the safety of the childhood immunization schedule
To address public concern about the safety of the childhood immunization schedule, the Institute of Medicine recommended observational studies comparing…
Identifying birth defects in automated data sources in the Vaccine Safety Datalink
The Vaccine Safety Datalink (VSD), a collaboration between the Centers for Disease Control and Prevention and several large healthcare organizations,…
Risk factors and familial clustering for fever 7-10days after the first dose of measles vaccines
Seven to ten days after a first dose of a measles-containing vaccine (MCV; i.e., MMR or MMRV), children have elevated…
Time to Change Dosing of Inactivated Quadrivalent Influenza Vaccine in Young Children: Evidence From a Phase III, Randomized, Controlled Trial
Children under 3 years of age may benefit from a double-dose of inactivated quadrivalent influenza vaccine (IIV4) instead of the…
Lot-to-Lot Consistency, Safety, Tolerability, and Immunogenicity of an Investigational Hexavalent Vaccine in US Infants
This multicenter phase III study (NCT01340937) evaluated the consistency of immune responses to 3 separate lots of diphtheria-tetanus toxoids-acellular pertussis…
Association Between Influenza Infection and Vaccination During Pregnancy and Risk of Autism Spectrum Disorder
Maternal infections and fever during pregnancy are associated with increased risk for autism spectrum disorders (ASDs). To our knowledge, no…
Acute demyelinating events following vaccines – a case centered analysis
Case reports have suggested that vaccines may trigger transverse myelitis (TM) or acute disseminated encephalomyelitis (ADEM), but the evidence for…
Kaiser Permanente Northern California pregnancy database: Description and proof of concept study
We describe the establishment of a dynamic database linking mothers to newborns with the goal of studying vaccine safety in…
Risk of underlying chronic medical conditions for invasive pneumococcal disease in adults
In the United States, the 13-valent pneumococcal conjugate vaccine is recommended in persons ⩾65years of age, and persons ⩽65years of…
Risk of Preterm or Small-for-Gestational-Age Birth After Influenza Vaccination During Pregnancy: Caveats When Conducting Retrospective Observational Studies
Vaccines are increasingly targeted toward women of reproductive age, and vaccines to prevent influenza and pertussis are recommended during pregnancy.…
Safety of DTaP-IPV/Hib vaccine administered routinely to infants and toddlers
The combination DTaP-IPV/Hib vaccine was licensed in the United States in 2008 for children ages 6weeks through 4years with doses…
Case centered analysis of Optic Neuritis following vaccines
We evaluated the risk of optic neuritis (ON) after vaccines, using a case-centered analysis, comparing the time since vaccination for…
Five-Year Antibody Persistence and Booster Response Following One or Two Doses of Meningococcal A, C, W, and Y Tetanus Toxoid Conjugate Vaccine in Healthy Children
We evaluated antibody persistence up to 5 years postvaccination with a quadrivalent meningococcal serogroups A, C, W and Y tetanus…
Influenza Vaccination During Pregnancy: Influenza Seasons 2002-2012, Vaccine Safety Datalink
Pregnant women are at risk for influenza-related complications and have been recommended for vaccination by the Advisory Committee on Immunization…
Maternal Tdap vaccination: Coverage and acute safety outcomes in the vaccine safety datalink, 2007-2013
Since October 2012, the combined tetanus toxoid, reduced diphtheria toxoid, acellular pertussis vaccine (Tdap) has been recommended in the United…
Absence of venous thromboembolism risk following quadrivalent human papillomavirus vaccination, Vaccine Safety Datalink, 2008-2011
To investigate concerns about a potential association between quadrivalent human papillomavirus vaccination (HPV4) and venous thromboembolism (VTE), we conducted a…
An Overview of Quadrivalent Human Papillomavirus Vaccine Safety – 2006 to 2015
A quadrivalent human papillomavirus (HPV4) type 6/11/16/18 vaccine (GARDASIL/SILGARD®) has been licensed in many countries around the world for the…
Safety of Measles-Containing Vaccines in 1-Year-Old Children
All measles-containing vaccines are associated with several types of adverse events, including seizure, fever, and immune thrombocytopenia purpura (ITP). Because…
Geographic Clusters in Underimmunization and Vaccine Refusal
Parental refusal and delay of childhood vaccines has increased in recent years and is believed to cluster in some communities.…
Childhood vaccines and Kawasaki disease, Vaccine Safety Datalink, 1996-2006
Kawasaki disease is a childhood vascular disorder of unknown etiology. Concerns have been raised about vaccinations being a potential risk…
Evaluation of the association of maternal pertussis vaccination with obstetric events and birth outcomes
In 2010, due to a pertussis outbreak and neonatal deaths, the California Department of Health recommended that the tetanus toxoid,…
Receipt of pertussis vaccine during pregnancy across 7 Vaccine Safety Datalink Sites
In response to widespread pertussis outbreaks and infant deaths, in 2010, the California Department of Health (CDPH) and in 2011…
Integrating database knowledge and epidemiological design to improve the implementation of data mining methods that evaluate vaccine safety in large healthcare databases
Large healthcare databases maintained by health plans have been widely used to conduct customized protocol-based epidemiological safety studies as well…
The Vaccine Safety Datalink: successes and challenges monitoring vaccine safety
The Vaccine Safety Datalink (VSD) is a collaborative project between the Centers for Disease Control and Prevention (CDC) and 9…
Impact of Vaccination on the Epidemiology of Varicella: 1995-2009
When varicella vaccine was licensed in the United States in 1995, there were concerns that childhood vaccination might increase the…
Timely Versus Delayed Early Childhood Vaccination and Seizures
Little is known regarding the timing of childhood vaccination and postvaccination seizures. In a cohort of 323?247 US children from…
Safety of diphtheria, tetanus, acellular pertussis and inactivated poliovirus (DTaP-IPV) vaccine
In 2008, a diphtheria, tetanus, acellular pertussis, and inactivated poliovirus combined vaccine (DTaP-IPV) was licensed for use in children 4…
Live Vaccine Use and Safety in DiGeorge Syndrome
Live vaccines are generally contraindicated in patients with DiGeorge syndrome (DGS), a congenital disorder characterized by cellular immune deficiency. Vaccine…
Risk of Intussusception after Monovalent Rotavirus Vaccination
Although current rotavirus vaccines were not associated with an increased risk of intussusception in large trials before licensure, recent postlicensure…
Vaccinations given during pregnancy, 2002-2009: a descriptive study
A number of studies have described influenza vaccination coverage during pregnancy but few publications have described rates of other vaccinations.…
Protective Association Between Rotavirus Vaccination and Childhood Seizures in the Year Following Vaccination in US Children
Rotavirus illness has been linked to childhood seizures. We investigated whether a protective association exists between receipt of rotavirus vaccine…
Licensed pertussis vaccines in the United States
The United States switched from whole cell to acellular pertussis vaccines in the 1990s following global concerns with the safety…
Effect of Age on the Risk of Fever and Seizures Following Immunization With Measles-Containing Vaccines in Children
IMPORTANCE The first dose of live attenuated measles-containing vaccines is associated with an increased risk of febrile seizures 7 to…
Factors that may explain observed associations between trivalent influenza vaccination and gastrointestinal illness in young children
Previously published studies reported an increased risk of gastrointestinal illness in the 14 days following trivalent influenza vaccination (TIV) in…
One or Two Doses of Quadrivalent Meningococcal Serogroups A, C, W-135 and Y Tetanus Toxoid Conjugate Vaccine is Immunogenic in 9-12 Month Old Children
The incidence of invasive meningococcal disease is highest in infants. A quadrivalent meningococcal serogroups A, C, W-135 and Y tetanus…
Lack of Association of Guillain-Barre Syndrome with Vaccinations
Guillain-Barré syndrome (GBS) is an acute polyradiculoneuropathy, thought to be an autoimmune process. Although cases of GBS have been reported…
Cervical Intraepithelial Neoplasia Grade 3 and Adenocarcinoma in situ: Comparison of ICD-9 Codes and Pathology Results – Kaiser Permanente, United States, 2000-2005
Cervical intraepithelial neoplasia grade 3+ (CIN3+) and adenocarcinoma in situ incidence will be an important measure of HPV vaccine impact.…
Long-term Effectiveness of Varicella Vaccine: A 14-Year, Prospective Cohort Study
BACKGROUND: Varicella vaccine was licensed in the United States in 1995 for individuals >/=12 months of age. A second dose…
Prevalence of HPV types in cervical specimens from an integrated healthcare delivery system: baseline assessment to measure HPV vaccine impact
PURPOSE: Two human papillomavirus (HPV) vaccines are available to prevent cervical cancer. One early measure of HPV vaccine impact would…
Clinical Assessment of Serious Adverse Events in Children Receiving 2009 H1N1 Vaccination
BACKGROUND: Monovalent 2009 H1N1 influenza vaccines were licensed and administered in the United States during the H1N1 influenza pandemic between…
Adapting Group Sequential Methods to Observational Postlicensure Vaccine Safety Surveillance: Results of a Pentavalent Combination DTaP-IPV-Hib Vaccine Safety Study
To address gaps in traditional postlicensure vaccine safety surveillance and to promote rapid signal identification, new prospective monitoring systems using…
Kaiser Permanente Vaccine Study Center: Highlights of 2009-2012
The Kaiser Permanente Vaccine Study Center is a specialized research organization in Oakland, California. They have been an active vaccine…
Biologically plausible and evidence-based risk intervals in immunization safety research
In immunization safety research, individuals are considered at risk for the development of certain adverse events following immunization (AEFI) within…
Safety of Quadrivalent Human Papillomavirus Vaccine Administered Routinely to Females
OBJECTIVE: To assess the safety of the quadrivalent human papillomavirus vaccine (HPV4) in females following routine administration. DESIGN: In a…
Causality assessment of adverse events reported to the Vaccine Adverse Event Reporting System (VAERS)
Adverse events following immunization (AEFI) reported to the national Vaccine Adverse Event Reporting System (VAERS) represent true causally related events,…
Safety of Zostavax-A cohort study in a managed care organization
BACKGROUND: Zostavax is a live, attenuated varicella-zoster virus vaccine indicated for the prevention of herpes zoster (shingles). An observational post-licensure…
Waning protection after fifth dose of acellular pertussis vaccine in children
BACKGROUND: In the United States, children receive five doses of diphtheria, tetanus, and acellular pertussis (DTaP) vaccine before 7 years…
Algorithm to assess causality after individual adverse events following immunizations
Assessing individual reports of adverse events following immunizations (AEFI) can be challenging. Most published reviews are based on expert opinions,…
Underimmunization at discharge from the neonatal intensive care unit
OBJECTIVE: The objectives of this study are to determine immunization rates at discharge from the neonatal intensive care unit (NICU)…
Immunogenicity and Safety of Two Tetravalent (Measles, Mumps, Rubella, Varicella) Vaccines Co-Administered with Hepatitis A and Pneumococcal Conjugate Vaccines to Children 12 14 Months of Age
BACKGROUND:: This study compared single-dose tetravalent measles, mumps, rubella, varicella (MMRV) vaccine, Priorix-Tetra, stored refrigerated (GSK+4C) or frozen (GSK 20C),…
Assessing the safety of influenza vaccination in specific populations: children and the elderly
Comprehensive monitoring of the safety of influenza vaccines remains a public health priority, particularly as immunization coverage increases across different…
An unmasking phenomenon in an observational post-licensure safety study of adolescent girls and young women
Our recent experience in a post-licensure safety study of autoimmune conditions following the quadrivalent human papillomavirus vaccine in 189,629 girls…
Immunogenicity and safety of a quadrivalent meningococcal conjugate vaccine administered concomitantly with measles, mumps, rubella, varicella vaccine in healthy toddlers
BACKGROUND: Invasive meningococcal disease can have devastating outcomes, especially in high-risk groups such as infants. As infants are recommended to…
Risk of Confirmed Guillain-Barre Syndrome Following Receipt of Monovalent Inactivated Influenza A (H1N1) and Seasonal Influenza Vaccines in the Vaccine Safety Datalink Project, 2009-2010
An increased risk of Guillain-Barre syndrome (GBS) following administration of the 1976 swine influenza vaccine led to a heightened focus…
Trends and Characteristics of Culture-Confirmed Staphylococcus aureus Infections in a Large U.S. Integrated Health Care Organization
Infections due to Staphylococcus aureus present a significant health problem in the United States. Between 1990 and 2005, there was…
Comparative immunogenicity and safety of different multivalent component pertussis vaccine formulations and a 5-component acellular pertussis vaccine in infants and toddlers: A randomized, controlled, open-label, multicenter study
BACKGROUND: Pentavalent and quadrivalent combination vaccine formulations from the same manufacturer (DTaP-IPV/Hib [PENTA], DTaP-IPV [QUAD]) were investigated as to whether…
Safety of Zoster Vaccine in Adults from a Large Managed Care Cohort: A Vaccine Safety Datalink Study
OBJECTIVES: The aim of this study was to examine a large cohort of adults who received the zoster vaccine for…
Immunization and Bell’s Palsy in Children: A Case-Centered Analysis
Bell's palsy (BP) is an acute and idiopathic paralysis of the facial nerve, with an estimated incidence ranging from 11.5…
Measles-Containing Vaccines and Febrile Seizures in Children Age 4 to 6 Years
BACKGROUND: In the United States, children receive 2 doses of measles-mumps-rubella vaccine (MMR) and varicella vaccine (V), the first between…
Recurrent Guillain-Barre Syndrome Following Vaccination
BACKGROUND: Guillain-Barre syndrome (GBS) is an acute polyradiculopathy, thought to be autoimmune, which has been reported following vaccinations. The Advisory…
Risk of intussusception following administration of a pentavalent rotavirus vaccine in US infants
CONTEXT: Current rotavirus vaccines were not associated with intussusception in large prelicensure trials. However, recent postlicensure data from international settings…
Surveillance of Autoimmune Conditions following Routine Use of Quadrivalent Human Papillomavirus Vaccine
OBJECTIVE: An observational safety study of the quadrivalent human papillomavirus vaccine (HPV4) in women was conducted. This report presents findings…
An open-label, randomized, multi-center study of the immunogenicity and safety of DTaP-IPV (Kinrix) co-administered with MMR vaccine with or without varicella vaccine in healthy pre-school age children
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…
Lack of association between childhood immunizations and encephalitis in California, 1998-2008
OBJECTIVE: A number of new and combination vaccines have been introduced for children in the past two decades. Encephalitis cases…
Safety and Immunogenicity of a Novel Quadrivalent Meningococcal CRM-Conjugate Vaccine Given Concomitantly With Routine Vaccinations in Infants
BACKGROUND: In phase II studies, MenACWY-CRM elicited robust immunologic responses in young infants. We now present results from our pivotal…
Epidemiologic and Clinical Features of Bell’s Palsy among Children in Northern California
BACKGROUND: Bell's palsy (BP) is an acute, idiopathic, and usually unilateral paralysis of the facial nerve. Large population-based studies of…
Causality assessment of serious neurologic adverse events following 2009 H1N1 vaccination
BACKGROUND: Adverse events occurring after vaccination are routinely reported to the Vaccine Adverse Event Reporting System (VAERS). We studied serious…
Monitoring the safety of quadrivalent human papillomavirus vaccine: Findings from the Vaccine Safety Datalink
BACKGROUND: In 7 large managed care organizations (MCOs), we performed a post-licensure safety assessment of quadrivalent human papillomavirus vaccine (HPV4)…
Risk of rheumatoid arthritis following vaccination with tetanus, influenza and hepatitis B vaccines among persons 15-59 years of age
BACKGROUND: Associations between vaccinations, particularly hepatitis B, and onset of rheumatoid arthritis (RA) have been reported, but examined in few…
Immunogenicity and Safety of an Inactivated Hepatitis A Vaccine When Coadministered With Diphtheria-tetanus-acellular Pertussis and Haemophilus influenzae Type B Vaccines in Children 15 Months of Age
BACKGROUND: This study (NCT00197236) evaluated the safety and immunogenicity of a hepatitis A virus (HAV) vaccine when coadministered with diphtheria-tetanus-acellular…
Safety of trivalent inactivated influenza vaccine in children aged 24 to 59 months in the vaccine safety datalink
OBJECTIVES: To evaluate the safety of trivalent inactivated influenza vaccine (TIV) in children aged 24 to 59 months and to…
H1N1 and seasonal influenza vaccine safety in the vaccine safety datalink project
BACKGROUND: The emergence of pandemic H1N1 influenza virus in early 2009 prompted the rapid licensure and use of H1N1 monovalent…
Attitudes and beliefs of parents concerned about vaccines: impact of timing of immunization information
OBJECTIVES: To determine if giving vaccine-information materials before the 2-month vaccination visit to mothers with concerns about vaccine safety positively…
The Vaccine Safety Datalink: a model for monitoring immunization safety
The Vaccine Safety Datalink (VSD) project is a collaborative project between the Centers for Disease Control and Prevention and 8…
Understanding the role of human variation in vaccine adverse events: the Clinical Immunization Safety Assessment Network
The Clinical Immunization Safety Assessment (CISA) Network is a collaboration between the Centers for Disease Control and Prevention (CDC) and…
Active surveillance for adverse events: the experience of the Vaccine Safety Datalink project
OBJECTIVE: To describe the Vaccine Safety Datalink (VSD) project's experience with population-based, active surveillance for vaccine safety and draw lessons…
Evaluation of immunization rates and safety among children with inborn errors of metabolism
BACKGROUND: Children with inherited metabolic disorders are a potential high-risk group for vaccine-preventable diseases, yet information regarding immunization rates and…
Vaccine safety in special populations
Studies evaluating the safety of vaccines routinely administered to a population of healthy infants and children may not provide adequate…
Comparison of the safety and immunogenicity of an investigational and a licensed quadrivalent meningococcal conjugate vaccine in children 2-10 years of age
BACKGROUND: Routine administration of quadrivalent meningococcal conjugate vaccine to adolescents and certain high risk groups is recommended in the United…
Effect of influenza vaccination on hospitalizations in persons aged 50 years and older
OBJECTIVE: To estimate influenza vaccine effectiveness (VE) in preventing hospitalizations in persons over 50 years of age. DESIGN: We performed…
A Phase III evaluation of immunogenicity and safety of two trivalent inactivated seasonal influenza vaccines in US children
BACKGROUND: This study (NCT00383123) compared the immunogenicity and safety of 2 trivalent inactivated influenza vaccines: Fluarix [GlaxoSmithKline (study vaccine)] and…
Vaccine effectiveness against laboratory-confirmed influenza in infants: A matched case control study
Influenza is a common and potentially serious infection in infants. Previous studies of influenza vaccine in this age group have…
Risk of fever and sepsis evaluations after routine immunizations in the neonatal intensive care unit
OBJECTIVE: Premature infants can experience cardiorespiratory events such as apnea after immunization in the neonatal intensive care unit (NICU). These…
Lack of association between acellular pertussis vaccine and seizures in early childhood
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…
Measles-mumps-rubella-varicella combination vaccine and the risk of febrile seizures
OBJECTIVE: In February 2008, we alerted the Advisory Committee on Immunization Practices to preliminary evidence of a twofold increased risk…
Post-marketing safety evaluation of a tetanus toxoid, reduced diphtheria toxoid and 3-component acellular pertussis vaccine administered to a cohort of adolescents in a United States health maintenance organization
BACKGROUND: Prelicensure clinical studies may not include sufficient numbers of subjects to assess the potential for rare postvaccination adverse events.…
Rates of autoimmune diseases in Kaiser Permanente for use in vaccine adverse event safety studies
Safety monitoring following new vaccine introduction includes assessment of potential new onset autoimmune diseases (AID). As knowledge regarding AID background…
Near real-time surveillance for influenza vaccine safety: proof-of-concept in the Vaccine Safety Datalink Project
The emergence of pandemic H1N1 influenza in 2009 has prompted public health responses, including production and licensure of new influenza…
Evidence of bias in studies of influenza vaccine effectiveness in elderly patients
Although studies have shown influenza vaccines to be effective in preventing death in the elderly population, these findings may be…
Preterm infants’ T cell responses to inactivated poliovirus vaccine
BACKGROUND: The antigen-specific T cell responses of preterm infants to immunization are not well understood. The aim of the present…
Immunogenicity and tolerability of a quadrivalent meningococcal glycoconjugate vaccine in children 2-10 years of age
Meningococcal disease incidence is highest in infants, but a significant burden of disease also occurs in children. In this Phase…
Real-time surveillance to assess risk of intussusception and other adverse events after pentavalent, bovine-derived rotavirus vaccine
BACKGROUND: A pentavalent, bovine-derived rotavirus vaccine (RotaTeq, Merck) was licensed in 2006 for use in infants. A previously licensed rotavirus…
Differential maternal responses to a newly developed vaccine information pamphlet
We compared the response to a new vaccine information pamphlet with the current CDC Vaccine Information Statements (VIS) among recently…
Compliance with multiple-dose vaccine schedules among older children, adolescents, and adults: results from a vaccine safety datalink study
OBJECTIVES: We studied compliance with multiple-dose vaccine schedules, assessed factors associated with noncompliance, and examined timeliness of series completion among…
Influenza vaccination and mortality: differentiating vaccine effects from bias
It is widely believed that influenza (flu) vaccination of the elderly reduces all-cause mortality, yet randomized trials for assessing vaccine…
Varicella vaccination and ischemic stroke in children: is there an association?
BACKGROUND: Ischemic stroke is a known complication of varicella disease. Although there have been case reports of ischemic stroke after…
Recurrent sterile abscesses following aluminium adjuvant-containing vaccines
Abscess formation following immunisation is a previously reported complication, generally associated with microbial contamination of the vaccine. Less commonly, such…
Kinrix: a new combination DTaP-IPV vaccine for children aged 4-6 years
Combination vaccines allow the administration of multiple vaccine antigens without the need for multiple injections. Recently, a combined diphtheria toxoid,…
Diphtheria-tetanus-acellular pertussis and inactivated poliovirus vaccines given separately or combined for booster dosing at 4-6 years of age
BACKGROUND: In the United States, diphtheria-tetanus-acellular pertussis (DTaP) and inactivated poliovirus (IPV) booster vaccinations are recommended for children 4-6 years…
Risk factors for developing apnea after immunization in the neonatal intensive care unit
OBJECTIVES: Among hospitalized NICU infants, preimmunization apnea is a well-recognized predictor of postimmunization apnea. However, predictors for postimmunization apnea among…
Case-control study of antibiotic use and subsequent Clostridium difficile-associated diarrhea in hospitalized patients
OBJECTIVE: To determine which antibiotics increase or decrease the risk of Clostridium difficile-associated diarrhea (CDAD). DESIGN: Retrospective case-control study. SETTING:…
Real-time vaccine safety surveillance for the early detection of adverse events
BACKGROUND: Rare but serious adverse events associated with vaccines or drugs are often nearly impossible to detect in prelicensure studies…
Surveillance for invasive pneumococcal disease during 2000-2005 in a population of children who received 7-valent pneumococcal conjugate vaccine
OBJECTIVES: To assess the incidence of invasive pneumococcal disease (IPD) in all children younger than 5 years of age in…
A role for genetics in the immune response to the varicella vaccine
BACKGROUND: A wide range in antibody titers has been found after immunization with the varicella vaccine, although the basis for…
Effectiveness of heptavalent pneumococcal conjugate vaccine in children younger than 5 years of age for prevention of pneumonia: updated analysis using World Health Organization standardized interpretation of chest radiographs
BACKGROUND: A World Health Organization (WHO) working group in 2001 developed a method for standardizing interpretation of chest radiographs in…
Cost-effectiveness of pneumococcal conjugate vaccine: evidence from the first 5 years of use in the United States incorporating herd effects
BACKGROUND: Pneumococcal conjugate vaccine (PCV) has been in routine use in the United States for 5 years. Prior U.S. cost-effectiveness…
Impact of the use of heptavalent pneumococcal conjugate vaccine on disease epidemiology in children and adults
Pneumococcal conjugate vaccine was introduced for routine use in infants and toddlers in the United States in March 2000. We…
Effectiveness of influenza vaccine during pregnancy in preventing hospitalizations and outpatient visits for respiratory illness in pregnant women and their infants
The Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention recommends influenza vaccination for women who…
Postlicensure surveillance for pneumococcal invasive disease after use of heptavalent pneumococcal conjugate vaccine in Northern California Kaiser Permanente
OBJECTIVE: To assess the direct and indirect effects of the introduction of routine use of pneumococcal conjugate vaccine in infants…
Impact of the pneumococcal conjugate vaccine on otitis media
CONTEXT: The heptavalent pneumococcal conjugate vaccine (PCV) is recommended for infants to protect against invasive disease, but its impact on…
Effectiveness of heptavalent pneumococcal conjugate vaccine in children younger than five years of age for prevention of pneumonia
OBJECTIVE: To determine the effectiveness of the Wyeth heptavalent pneumococcal conjugate vaccine against clinical and radiograph-confirmed pneumonia in children. METHODS:…
Lack of association between receipt of conjugate haemophilus influenzae type B vaccine (HbOC) in infancy and risk of type 1 (juvenile onset) diabetes: long term follow-up of the HbOC efficacy trial cohort
We evaluated the effect of infant vaccination with HbOC Haemophilus influenzae type b (Hib) conjugate vaccine on the risk of…
Observed costs and health care use of children in a randomized controlled trial of pneumococcal conjugate vaccine
BACKGROUND: Pneumococcal conjugate vaccine for infants has recently been found to be effective for prevention of meningitis, bacteremia, pneumonia and…
Efficacy, immunogenicity and safety of heptavalent pneumococcal conjugate vaccine in low birth weight and preterm infants
OBJECTIVE: To determine the efficacy, immunogenicity and safety of the heptavalent CRM197 pneumococcal conjugate vaccine (PCV) in low birth weight…
Use of a Staphylococcus aureus conjugate vaccine in patients receiving hemodialysis
BACKGROUND: In patients with decreased resistance to infection, Staphylococcus aureus is a major cause of bacteremia and its complications. The…
Safety and immunogenicity of heptavalent pneumococcal CRM197 conjugate vaccine in infants and toddlers
OBJECTIVES: The objectives of this study were (1) to determine the safety and immunogenicity of heptavalent pneumococcal CRM197 conjugate (PNCRM7)…
Safety and immunogenicity of oligosaccharide conjugate Haemophilus influenzae type b (HbOC) vaccine in infancy. The Northern California Kaiser Permanente Vaccine Study Center Pediatrics Group
The safety and immunogenicity of the HbOC conjugate vaccine have been evaluated in a study population of 61,080 children in…
Efficacy in infancy of oligosaccharide conjugate Haemophilus influenzae type b (HbOC) vaccine in a United States population of 61,080 children. The Northern California Kaiser Permanente Vaccine Study Center Pediatrics Group
The efficacy of the HbOC conjugate Haemophilus influenzae type b vaccine was evaluated in a study population of 61,080 infants…
Efficacy of Haemophilus influenzae type b capsular polysaccharide vaccine
The efficacy of the Haemophilus influenzae type b (Hib) polyribose phosphate vaccine was evaluated in a population of 120,000 children…
