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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 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 165 participants.
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).
Interventions
- BIOLOGICAL Boostrix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 165 participants |
| Start Date | 2013-01-31 |
| Est. Completion | 2014-04-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01738477
The ClinicalTrials.gov registry entry for NCT01738477 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 165 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Boostrix is the first listed.
NCT01738477 reports 0 study locations.
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.
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