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NCT00346073 · ClinicalTrials.gov registry record · Phase 3
Safety and Immunogenicity of GSK's Tdap Vaccine (Boostrix) in Adults Aged 19 to 64 Years
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,337
- Enrollment target
NCT00346073: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT00346073 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 2,337 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (203% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00346073, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,337 participants
- Enrollment target
Study Summary
GSK Biologicals' dTpa vaccine has recently been approved by the US Food and Drug Administration (FDA) for booster vaccination of adolescents aged 10 to 18 years. The ACIP has recently issued provisional recommendations for universal adult Tdap vaccination. The current study will provide pivotal data in support of extending the age range for Boostrix vaccine to include adults 19-64 years of age.
Primary Outcome
A seroprotected subject is defined as a vaccinated subject with anti-D and anti-T antibody concentration greater than or equal to ( ≥) 0.1 international units per milliliter (IU/mL).
Interventions
- BIOLOGICAL Boostrix™
- BIOLOGICAL ADACEL®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,337 participants |
| Start Date | 2006-07-13 |
| Est. Completion | 2007-03-07 |
| Phase | Phase 3 |
What the finished NCT00346073 record still lists
NCT00346073 is an interventional study that assigns participants to a tested intervention. Its 2,337 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (203% higher).
The record links to 0 conditions, and to 2 interventions - of which Boostrix™ is the first listed.
NCT00346073 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00346073 about?
NCT00346073 is a clinical study titled "Safety and Immunogenicity of GSK's Tdap Vaccine (Boostrix) in Adults Aged 19 to 64 Years". GSK Biologicals' dTpa vaccine has recently been approved by the US Food and Drug Administration (FDA) for booster vaccination of adolescents aged 10 to 18 years. The ACIP has recently issued provisional recommendations for universal adult Tdap vaccination. The current study will provide pivotal data...
What is the current status of trial NCT00346073?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,337 participants. The study started on 2006-07-13. Estimated completion is 2007-03-07.
What interventions are being tested in trial NCT00346073?
The interventions under investigation include: Boostrix™ (BIOLOGICAL), ADACEL® (BIOLOGICAL).
Who is sponsoring clinical trial NCT00346073?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00346073's enrollment target sits among peer trials
2,337 92nd of 2000 higher than 1,909 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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