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NCT00985673 · ClinicalTrials.gov registry record · Phase 2
Safety and Immunogenicity of H1N1 Vaccine With Trivalent Inactivated Seasonal Influenza Vaccine in Adults
A Phase 2 study of Influenza, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 611
- Enrollment target
- 7
- Study locations
NCT00985673: Completed Phase 2 study of Influenza, sponsored by GlaxoSmithKline.
NCT00985673 is a Phase 2 study of Influenza that has completed, run by GlaxoSmithKline. The registered enrollment target is 611 participants, below the 36,800-participant average among 156 other Influenza trials with a reported enrollment target (98% lower). The trial reports 7 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00985673, a Phase 2 study of Influenza, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 611 participants
- Enrollment target
- 7
- Study locations
Study Summary
The purpose of this study is to characterize the safety and immunogenicity of the H1N1 (swine) flu vaccines GSK2340274A and GSK2340273A when co-administered with the seasonal flu vaccine in adults 19 to 40 years of age.
Primary Outcome
The A/California vaccine virus-homologous antibody response was measured in subjects having received Flulaval vaccine co-administered with the first dose of Arepanrix vaccine, and in subjects having received two doses of Arepanrix vaccine alone. Titers were expressed as geometric mean antibody titers (GMTs).
Conditions Studied
Interventions
- BIOLOGICAL GSK2340274A
- BIOLOGICAL GSK2340273A
- BIOLOGICAL Seasonal trivalent influenza vaccine (TIV)
- BIOLOGICAL Saline placebo
Study Locations (7)
Texas
- GSK Investigational Site - Austin
- GSK Investigational Site - Fort Worth
Quebec
- GSK Investigational Site - Montreal
- GSK Investigational Site - Sherbrooke
Georgia
- GSK Investigational Site - Stockbridge
North Carolina
- GSK Investigational Site - Raleigh
Nova Scotia
- GSK Investigational Site - Halifax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 611 participants |
| Start Date | 2009-10-01 |
| Est. Completion | 2010-12-29 |
| Phase | Phase 2 |
What the finished NCT00985673 record still lists
NCT00985673 is an interventional study that assigns participants to a tested intervention. The registered 611 participants enrollment target is mid-sized for trials with a published cap, below the 36,800-participant average among 156 other Influenza trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Influenza appearing as the primary indexed condition, and to 4 interventions - of which GSK2340274A is the first listed.
NCT00985673 lists 7 locations in 5 states (Texas, Quebec, Georgia).
Frequently Asked Questions
What is clinical trial NCT00985673 about?
NCT00985673 is a clinical study titled "Safety and Immunogenicity of H1N1 Vaccine With Trivalent Inactivated Seasonal Influenza Vaccine in Adults". The purpose of this study is to characterize the safety and immunogenicity of the H1N1 (swine) flu vaccines GSK2340274A and GSK2340273A when co-administered with the seasonal flu vaccine in adults 19 to 40 years of age.
What is the current status of trial NCT00985673?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 611 participants. The study started on 2009-10-01. Estimated completion is 2010-12-29.
What conditions does trial NCT00985673 study?
This clinical trial studies the following conditions: Influenza.
What interventions are being tested in trial NCT00985673?
The interventions under investigation include: GSK2340274A (BIOLOGICAL), GSK2340273A (BIOLOGICAL), Seasonal trivalent influenza vaccine (TIV) (BIOLOGICAL), Saline placebo (BIOLOGICAL).
Who is sponsoring clinical trial NCT00985673?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00985673 being conducted?
This trial has 7 study locations across Georgia, North Carolina, Texas, Nova Scotia, Quebec. 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 NCT00985673's enrollment target sits among peer trials
611 42nd of 156 higher than 115 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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