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NCT01738477 · ClinicalTrials.gov registry record · Phase 3
Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Boostrix™ Vaccine in Previously Boosted Young Adults
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 165
- Enrollment target
NCT01738477: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT01738477 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 165 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01738477, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 165 participants
- Enrollment target
Study Summary
The purpose of this follow-up study is to evaluate the persistence of antibodies against all the vaccine antigens 10 years after booster vaccination with either Tdap or Td, and also to assess immunogenicity and safety of another dose of Boostrix, administered in this study. This protocol posting deals with objectives and outcome measures of the extension phase. The objectives and outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00109330).
Primary Outcome
A seroprotected subject was defined as a subject with anti-D/anti-T antibody concentrations above or equal (≥) to 0.1 IU/mL (international units per milliliter)
Interventions
- BIOLOGICAL Boostrix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 165 participants |
| Start Date | 2013-01-31 |
| Est. Completion | 2014-04-02 |
| Phase | Phase 3 |
What the finished NCT01738477 record still lists
NCT01738477 is an interventional study that assigns participants to a tested intervention. The registered 165 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (79% lower).
The record links to 0 conditions, and to 1 intervention - of which Boostrix is the first listed.
NCT01738477 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01738477 about?
NCT01738477 is a clinical study titled "Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Boostrix™ Vaccine in Previously Boosted Young Adults". The purpose of this follow-up study is to evaluate the persistence of antibodies against all the vaccine antigens 10 years after booster vaccination with either Tdap or Td, and also to assess immunogenicity and safety of another dose of Boostrix, administered in this study. This protocol posting dea...
What is the current status of trial NCT01738477?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 165 participants. The study started on 2013-01-31. Estimated completion is 2014-04-02.
What interventions are being tested in trial NCT01738477?
The interventions under investigation include: Boostrix (BIOLOGICAL).
Who is sponsoring clinical trial NCT01738477?
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 NCT01738477's enrollment target sits among peer trials
165 1465th of 2000 higher than 531 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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