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NCT00385255 · ClinicalTrials.gov registry record · Phase 3
Immunogenicity, Safety of GSKs Tdap Vaccine Boostrix When Coadministered With GSKs Influenza Vaccine Fluarix in Adults
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,726
- Enrollment target
NCT00385255: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT00385255 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 1,726 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (124% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00385255, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,726 participants
- Enrollment target
Study Summary
The current study will provide information for the use of Boostrix concomitantly with influenza vaccine in adults aged 19-64 years. This study will also provide safety and immunogenicity data in a cohort of adults aged greater than or equal to 65 years.
Primary Outcome
A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations equal to or above (≥) 0.1 International Units per milliliter (IU/mL), respectively.
Interventions
- BIOLOGICAL Boostrix®
- BIOLOGICAL Fluarix®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,726 participants |
| Start Date | 2006-10-23 |
| Est. Completion | 2007-02-28 |
| Phase | Phase 3 |
What the finished NCT00385255 record still lists
NCT00385255 is an interventional study that assigns participants to a tested intervention. Its 1,726 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 (124% higher).
The record links to 0 conditions, and to 2 interventions - of which Boostrix® is the first listed.
NCT00385255 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00385255 about?
NCT00385255 is a clinical study titled "Immunogenicity, Safety of GSKs Tdap Vaccine Boostrix When Coadministered With GSKs Influenza Vaccine Fluarix in Adults". The current study will provide information for the use of Boostrix concomitantly with influenza vaccine in adults aged 19-64 years. This study will also provide safety and immunogenicity data in a cohort of adults aged greater than or equal to 65 years.
What is the current status of trial NCT00385255?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,726 participants. The study started on 2006-10-23. Estimated completion is 2007-02-28.
What interventions are being tested in trial NCT00385255?
The interventions under investigation include: Boostrix® (BIOLOGICAL), Fluarix® (BIOLOGICAL).
Who is sponsoring clinical trial NCT00385255?
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 NCT00385255's enrollment target sits among peer trials
1,726 130th of 2000 higher than 1,871 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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