Post-marketing Safety Study of GSK Biologicals' Boostrix® Vaccine
Open, Prospective Study of the Safety of GSK Biologicals' Boostrix® (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed) Administered to a Cohort of Adolescents in a US Health Maintenance Organization (HMO)
1 other identifier
observational
10,000
1 country
1
Brief Summary
Pre-licensure studies of GSK Biologicals' Boostrix® have shown it to be generally safe and well-tolerated. This post-licensure study is designed to evaluate relatively uncommon/rare outcomes in a large population cohort. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2006
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2006
CompletedFirst Posted
Study publicly available on registry
March 1, 2006
CompletedStudy Start
First participant enrolled
March 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedJanuary 13, 2014
January 1, 2014
9 months
February 28, 2006
January 9, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Occurrence of medically-attended neurological events.
30 days following vaccination with Boostrix.
Secondary Outcomes (5)
Occurrence of medically-attended hematologic events
30 days following vaccination with Boostrix
Occurrence of allergic reactions.
30 days following vaccination with Boostrix
Occurrence of new onset chronic illnesses
6-month period following vaccination with Boostrix
Occurrence of neurological and hematological events and allergic reactions
Within the second 30-day period following vaccination with Boostrix
Occurrence of chronic illnesses in an historical control cohort of subjects vaccinated with Td vaccine
Study Arms (2)
Boostrix cohort
Historical Td cohort
Interventions
Eligibility Criteria
Subjects enrolled in the Northern California Kaiser-Permanente Health Care Plan
You may qualify if:
- Subjects between the age of 10 and 18 years (inclusive) who received a dose of Boostrix and who have safety follow-up information available
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (1)
GSK Investigational Site
Oakland, California, 94612, United States
Related Publications (1)
Klein NP, Hansen J, Lewis E, Lyon L, Nguyen B, Black S, Weston WM, Wu S, Li P, Howe B, Friedland LR. 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. Pediatr Infect Dis J. 2010 Jul;29(7):613-7. doi: 10.1097/INF.0b013e3181d581f9.
PMID: 20190673BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2006
First Posted
March 1, 2006
Study Start
March 1, 2006
Primary Completion
December 1, 2006
Study Completion
December 1, 2006
Last Updated
January 13, 2014
Record last verified: 2014-01