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

NCT00297856 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 10000

Last updated 2014-01-13

No results posted yet for this study

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.

Conditions

  • Diphtheria
  • Tetanus
  • Acellular Pertussis

Interventions

BIOLOGICAL

Boostrix®

Single dose

BIOLOGICAL

Td (Tetanus diphtheria) vaccine

Single dose

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Eligibility

Min Age
10 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2006-12-31
Completion
2006-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00297856 on ClinicalTrials.gov