Post-marketing Safety Study of GSK Biologicals' Boostrix® Vaccine
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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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.
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)
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
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Ages Eligible for Study:
10 Years to 18 Years (Child, Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Subjects enrolled in the Northern California Kaiser-Permanente Health Care Plan
Subjects between the age of 10 and 18 years (inclusive) who received a dose of Boostrix and who have safety follow-up information available