Post-marketing Safety Study of GSK Biologicals' Boostrix® Vaccine

Completed

Conditions studied: Diphtheria, Tetanus, Acellular Pertussis

In brief

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.

Key facts

Study ID

NCT00297856

Run by

GlaxoSmithKline

People needed

10000

Starts

2006-03-01

Expected to finish

2006-12-01

Last updated by the study team

2014-01-13

Who can join

Age: 10 and older, up to 18. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• GSK Investigational Site — Oakland, California, United States

Full record on ClinicalTrials.gov

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