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NCT00979602 · ClinicalTrials.gov registry record · Phase 3
Safety, Immunogenicity, and Relative Efficacy of H1N1 Vaccines in Adults Aged 18 Years and Older
A Phase 3 study of Influenza, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 4,048
- Enrollment target
- 20
- Study locations
NCT00979602: Completed Phase 3 study of Influenza, sponsored by GlaxoSmithKline.
NCT00979602 is a Phase 3 study of Influenza that has completed, run by GlaxoSmithKline. The registered enrollment target is 4,048 participants, below the 36,778-participant average among 156 other Influenza trials with a reported enrollment target (89% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00979602, a Phase 3 study of Influenza, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 4,048 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to characterize the safety, immunogenicity, and relative efficacy of the H1N1 (swine) flu vaccines GSK2340273A and GSK2340274A in adults 18 years of age or older.
Primary Outcome
A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer higher than or equal to (≥)1:40 or at least a 4-fold increase of the pre-vaccination titer of ≥ 1:10. The Flu strain assessed was A/California/7/09 (H1N1)v-like (Flu A/CAL/7/09) in subjects of 18-60 years and older and 18-64 years and older, following the Committee for Medicinal Products for Human Use (CHMP) and the Center for Biologics Evaluation and Research (CBER) guidance.
Conditions Studied
Interventions
- BIOLOGICAL GSK2340274A
- BIOLOGICAL GSK2340273A
Study Locations (20)
Florida
- GSK Investigational Site - Clearwater
- GSK Investigational Site - DeLand
- GSK Investigational Site - Delray Beach
- GSK Investigational Site - Jacksonville
Arizona
- GSK Investigational Site - Mesa
- GSK Investigational Site - Phoenix
- GSK Investigational Site - Phoenix
Maryland
- GSK Investigational Site - Columbia
- GSK Investigational Site - Rockville
New York
- GSK Investigational Site - Binghamton
- GSK Investigational Site - Camillus
California
- GSK Investigational Site - Los Angeles
Illinois
- GSK Investigational Site - Chicago
Kansas
- GSK Investigational Site - Wichita
Kentucky
- GSK Investigational Site - Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,048 participants |
| Start Date | 2009-11-09 |
| Est. Completion | 2011-02-01 |
| Phase | Phase 3 |
What the finished NCT00979602 record still lists
NCT00979602 is an interventional study that assigns participants to a tested intervention. Its 4,048 participants enrollment target places it among the larger protocols in the corpus, below the 36,778-participant average among 156 other Influenza trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Influenza appearing as the primary indexed condition, and to 2 interventions - of which GSK2340274A is the first listed.
NCT00979602 names 20 study sites across 13 states, led by Florida, Arizona, Maryland.
Frequently Asked Questions
What is clinical trial NCT00979602 about?
NCT00979602 is a clinical study titled "Safety, Immunogenicity, and Relative Efficacy of H1N1 Vaccines in Adults Aged 18 Years and Older". The purpose of this study is to characterize the safety, immunogenicity, and relative efficacy of the H1N1 (swine) flu vaccines GSK2340273A and GSK2340274A in adults 18 years of age or older.
What is the current status of trial NCT00979602?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 4,048 participants. The study started on 2009-11-09. Estimated completion is 2011-02-01.
What conditions does trial NCT00979602 study?
This clinical trial studies the following conditions: Influenza.
What interventions are being tested in trial NCT00979602?
The interventions under investigation include: GSK2340274A (BIOLOGICAL), GSK2340273A (BIOLOGICAL).
Who is sponsoring clinical trial NCT00979602?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00979602 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Illinois, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Influenza
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00979602's enrollment target sits among peer trials
4,048 21st of 156 higher than 136 of 156 other Influenza trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Influenza 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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