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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 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00297856
The ClinicalTrials.gov registry entry for NCT00297856 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 10,000 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 1,200-participant average among 15 other Diphtheria trials with a reported enrollment target (733% higher). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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