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NCT01204671 · ClinicalTrials.gov registry record · Phase 3
Safety and Immunogenicity Study of GSK Biologicals' Seasonal Influenza Candidate Vaccine (GSK2321138A)
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 4,659
- Enrollment target
NCT01204671: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT01204671 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 4,659 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (503% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01204671, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 4,659 participants
- Enrollment target
Study Summary
This study is designed to assess the safety and immunogenicity of a GSK Biologicals' investigational vaccine GSK2321138A in adults 18 years old and older. This study is also designed to assess the lot-to-lot consistency of vaccine GSK2321138A. The blinding will be double blind for all groups except for the GSK2604409A Group which will be open.
Primary Outcome
Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. HI antibodies assessed were antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.
Interventions
- BIOLOGICAL Influenza vaccine GSK2321138A
- BIOLOGICAL FluarixTM
- BIOLOGICAL Influenza vaccine GSK2604409A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,659 participants |
| Start Date | 2010-10-04 |
| Est. Completion | 2011-06-06 |
| Phase | Phase 3 |
What the finished NCT01204671 record still lists
NCT01204671 is an interventional study that assigns participants to a tested intervention. Its 4,659 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 (503% higher).
The record links to 0 conditions, and to 3 interventions - of which Influenza vaccine GSK2321138A is the first listed.
NCT01204671 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01204671 about?
NCT01204671 is a clinical study titled "Safety and Immunogenicity Study of GSK Biologicals' Seasonal Influenza Candidate Vaccine (GSK2321138A)". This study is designed to assess the safety and immunogenicity of a GSK Biologicals' investigational vaccine GSK2321138A in adults 18 years old and older. This study is also designed to assess the lot-to-lot consistency of vaccine GSK2321138A. The blinding will be double blind for all groups except ...
What is the current status of trial NCT01204671?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 4,659 participants. The study started on 2010-10-04. Estimated completion is 2011-06-06.
What interventions are being tested in trial NCT01204671?
The interventions under investigation include: Influenza vaccine GSK2321138A (BIOLOGICAL), FluarixTM (BIOLOGICAL), Influenza vaccine GSK2604409A (BIOLOGICAL).
Who is sponsoring clinical trial NCT01204671?
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 NCT01204671's enrollment target sits among peer trials
4,659 54th of 2000 higher than 1,947 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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