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NCT00297856 · ClinicalTrials.gov registry record
Post-marketing Safety Study of GSK Biologicals' Boostrix® Vaccine
A clinical trial of Diphtheria and Tetanus, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- 10,000
- Enrollment target
- 1
- Study location
NCT00297856: Completed study of Diphtheria and Tetanus, sponsored by GlaxoSmithKline.
NCT00297856 is a study of Diphtheria and Tetanus that has completed, run by GlaxoSmithKline. The registered enrollment target is 10,000 participants, above the 1,200-participant average among 15 other Diphtheria trials with a reported enrollment target (733% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00297856, a study of Diphtheria and Tetanus, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- 10,000 participants
- Enrollment target
- 1
- Study location
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 Studied
Interventions
- BIOLOGICAL Boostrix®
- BIOLOGICAL Td (Tetanus diphtheria) vaccine
Study Locations (1)
California
- GSK Investigational Site - Oakland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10,000 participants |
| Start Date | 2006-03 |
| Est. Completion | 2006-12 |
What the finished NCT00297856 record still lists
NCT00297856 is an observational study that tracks outcomes without assigning an intervention. Its 10,000 participants enrollment target places it among the larger protocols in the corpus, above the 1,200-participant average among 15 other Diphtheria trials with a reported enrollment target (733% higher).
The record links to 3 conditions, with Diphtheria appearing as the primary indexed condition, and to 2 interventions - of which Boostrix® is the first listed.
NCT00297856 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT00297856 about?
NCT00297856 is a clinical study titled "Post-marketing Safety Study of GSK Biologicals' Boostrix® Vaccine". 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...
What is the current status of trial NCT00297856?
This trial is currently completed. The enrollment target is 10,000 participants. The study started on 2006-03. Estimated completion is 2006-12.
What conditions does trial NCT00297856 study?
This clinical trial studies the following conditions: Diphtheria, Tetanus, Acellular Pertussis.
What interventions are being tested in trial NCT00297856?
The interventions under investigation include: Boostrix® (BIOLOGICAL), Td (Tetanus diphtheria) vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00297856?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00297856 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diphtheria
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00297856's enrollment target sits among peer trials
10,000 1st of 15 higher than 15 of 15 other Diphtheria trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diphtheria trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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