Trials / Completed
CompletedNCT00297856
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)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 10,000 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 10 Years – 18 Years
- Healthy volunteers
- Accepted
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.
Detailed description
Data collection through utilization of automated databases at the study site. The collaborator is Kaiser Permanente Vaccine Study Center.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Boostrix® | Single dose |
| BIOLOGICAL | Td (Tetanus diphtheria) vaccine | Single dose |
Timeline
- Start date
- 2006-03-01
- Primary completion
- 2006-12-01
- Completion
- 2006-12-01
- First posted
- 2006-03-01
- Last updated
- 2014-01-13
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00297856. Inclusion in this directory is not an endorsement.