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NCT00985088 · ClinicalTrials.gov registry record · Phase 2
Safety and Immunogenicity of H1N1 Vaccines in Adults Aged 18 Years and Older
A Phase 2 study of Influenza, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 1,343
- Enrollment target
- 14
- Study locations
NCT00985088: Completed Phase 2 study of Influenza, sponsored by GlaxoSmithKline.
NCT00985088 is a Phase 2 study of Influenza that has completed, run by GlaxoSmithKline. The registered enrollment target is 1,343 participants, below the 36,795-participant average among 156 other Influenza trials with a reported enrollment target (96% lower). The trial reports 14 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00985088, a Phase 2 study of Influenza, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 1,343 participants
- Enrollment target
- 14
- Study locations
Study Summary
The purpose of this study is to characterize the safety and immunogenicity of the H1N1 (swine) flu vaccines GSK2340273A and GSK2340274A in adults 18 years of age or older. This protocol posting has been updated for sections impacted by the Protocol amendment 1, Sept 2009.
Primary Outcome
A seropositive subject against the A/California/ virus strain was defined as a subject with H1N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (≥) the seropositivity cut-off of 1:10. Results were tabulated according to age strata: subjects between 18 to 60 years (y) old and subjects older than (\>) 60 years.
Conditions Studied
Interventions
- BIOLOGICAL GSK2340274A
- BIOLOGICAL GSK2340273A
- BIOLOGICAL Saline placebo
Study Locations (14)
Florida
- GSK Investigational Site - Jacksonville
- GSK Investigational Site - Miami
Alabama
- GSK Investigational Site - Huntsville
Idaho
- GSK Investigational Site - Meridian
Kansas
- GSK Investigational Site - Lenexa
Montana
- GSK Investigational Site - Missoula
Nevada
- GSK Investigational Site - Las Vegas
New Jersey
- GSK Investigational Site - Edison
New York
- GSK Investigational Site - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,343 participants |
| Start Date | 2009-10-11 |
| Est. Completion | 2010-12-16 |
| Phase | Phase 2 |
What the finished NCT00985088 record still lists
NCT00985088 is an interventional study that assigns participants to a tested intervention. Its 1,343 participants enrollment target places it among the larger protocols in the corpus, below the 36,795-participant average among 156 other Influenza trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Influenza appearing as the primary indexed condition, and to 3 interventions - of which GSK2340274A is the first listed.
NCT00985088 lists 14 locations in 13 states (Florida, Alabama, Idaho).
Frequently Asked Questions
What is clinical trial NCT00985088 about?
NCT00985088 is a clinical study titled "Safety and Immunogenicity of H1N1 Vaccines in Adults Aged 18 Years and Older". The purpose of this study is to characterize the safety and immunogenicity of the H1N1 (swine) flu vaccines GSK2340273A and GSK2340274A in adults 18 years of age or older. This protocol posting has been updated for sections impacted by the Protocol amendment 1, Sept 2009.
What is the current status of trial NCT00985088?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 1,343 participants. The study started on 2009-10-11. Estimated completion is 2010-12-16.
What conditions does trial NCT00985088 study?
This clinical trial studies the following conditions: Influenza.
What interventions are being tested in trial NCT00985088?
The interventions under investigation include: GSK2340274A (BIOLOGICAL), GSK2340273A (BIOLOGICAL), Saline placebo (BIOLOGICAL).
Who is sponsoring clinical trial NCT00985088?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00985088 being conducted?
This trial has 14 study locations across Alabama, Florida, Idaho, Kansas, Montana. 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 NCT00985088's enrollment target sits among peer trials
1,343 32nd of 156 higher than 125 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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