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NCT01059617 · ClinicalTrials.gov registry record · Phase 1
Safety and Immune Response of Candidate H1N1 Influenza Vaccine GSK2340274A Following Seasonal Influenza Vaccination in Adults
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 133
- Enrollment target
NCT01059617: Completed Phase 1 study, sponsored by GlaxoSmithKline.
NCT01059617 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 133 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (122% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01059617, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 133 participants
- Enrollment target
Study Summary
This study is designed to characterize the safety and immunogenicity of a' pandemic influenza (H1N1) candidate vaccine GSK2340274A in adults 19 to 40 years who have never received influenza vaccination.
Primary Outcome
Seroconversion rate (SCR) was defined as the number of subjects who have either a pre-vaccination reciprocal HI titer \< 10 and a post-vaccination reciprocal titer ≥ 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.
Interventions
- BIOLOGICAL GSK Biologicals' FluLaval®
- BIOLOGICAL Placebo (saline)
- BIOLOGICAL GSK Biologicals' investigational H1N1 Influenza Vaccine - GSK2340274A
- BIOLOGICAL GSK Biologicals' investigational H1N1 Influenza Vaccine - GSK2340273A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 133 participants |
| Start Date | 2010-02-09 |
| Est. Completion | 2011-10-21 |
| Phase | Phase 1 |
What the finished NCT01059617 record still lists
NCT01059617 is an interventional study that assigns participants to a tested intervention. The registered 133 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 (122% higher).
The record links to 0 conditions, and to 4 interventions - of which GSK Biologicals' FluLaval® is the first listed.
NCT01059617 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01059617 about?
NCT01059617 is a clinical study titled "Safety and Immune Response of Candidate H1N1 Influenza Vaccine GSK2340274A Following Seasonal Influenza Vaccination in Adults". This study is designed to characterize the safety and immunogenicity of a' pandemic influenza (H1N1) candidate vaccine GSK2340274A in adults 19 to 40 years who have never received influenza vaccination.
What is the current status of trial NCT01059617?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 133 participants. The study started on 2010-02-09. Estimated completion is 2011-10-21.
What interventions are being tested in trial NCT01059617?
The interventions under investigation include: GSK Biologicals' FluLaval® (BIOLOGICAL), Placebo (saline) (BIOLOGICAL), GSK Biologicals' investigational H1N1 Influenza Vaccine - GSK2340274A (BIOLOGICAL), GSK Biologicals' investigational H1N1 Influenza Vaccine - GSK2340273A (BIOLOGICAL).
Who is sponsoring clinical trial NCT01059617?
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 NCT01059617's enrollment target sits among peer trials
133 432nd of 2000 higher than 1,569 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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