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NCT00510874 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Safety and Immune Response of Two-Doses of Candidate Influenza Vaccine GSK 1557484A in Adults
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 780
- Enrollment target
NCT00510874: Completed Phase 1 study, sponsored by GlaxoSmithKline.
NCT00510874 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 780 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (1200% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00510874, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 780 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and immune response of two-doses of GSK Biologicals' candidate influenza vaccine GSK 1557484A with or without adjuvant in adults. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Primary Outcome
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (\<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer on the specified day.
Interventions
- BIOLOGICAL Pumarix™
- BIOLOGICAL Pandemrix ™
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 780 participants |
| Start Date | 2007-07-28 |
| Est. Completion | 2008-10-24 |
| Phase | Phase 1 |
What the finished NCT00510874 record still lists
NCT00510874 is an interventional study that assigns participants to a tested intervention. The registered 780 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (1200% higher).
The record links to 0 conditions, and to 2 interventions - of which Pumarix™ is the first listed.
NCT00510874 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00510874 about?
NCT00510874 is a clinical study titled "Study to Evaluate the Safety and Immune Response of Two-Doses of Candidate Influenza Vaccine GSK 1557484A in Adults". The purpose of this study is to evaluate the safety and immune response of two-doses of GSK Biologicals' candidate influenza vaccine GSK 1557484A with or without adjuvant in adults. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
What is the current status of trial NCT00510874?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 780 participants. The study started on 2007-07-28. Estimated completion is 2008-10-24.
What interventions are being tested in trial NCT00510874?
The interventions under investigation include: Pumarix™ (BIOLOGICAL), Pandemrix ™ (BIOLOGICAL).
Who is sponsoring clinical trial NCT00510874?
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 NCT00510874's enrollment target sits among peer trials
780 14th of 2000 higher than 1,986 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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