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.
Data collection through utilization of automated databases at the study site. The collaborator is Kaiser Permanente Vaccine Study Center.
Study Type
OBSERVATIONAL
Enrollment
10,000
Single dose
Single dose
GSK Investigational Site
Oakland, California, United States
Occurrence of medically-attended neurological events.
Time frame: 30 days following vaccination with Boostrix.
Occurrence of medically-attended hematologic events
Time frame: 30 days following vaccination with Boostrix
Occurrence of allergic reactions.
Time frame: 30 days following vaccination with Boostrix
Occurrence of new onset chronic illnesses
Time frame: 6-month period following vaccination with Boostrix
Occurrence of neurological and hematological events and allergic reactions
Time frame: 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
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