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NCT01934127 · ClinicalTrials.gov registry record · Phase 1
Immunogenicity and Safety Study of Different Formulations of GlaxoSmithKline (GSK) Biologicals H7N1 Influenza Vaccine Administered to Adults 21 to 64 Years of Age
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 427
- Enrollment target
NCT01934127: Completed Phase 1 study, sponsored by GlaxoSmithKline.
NCT01934127 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 427 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (612% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01934127, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 427 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and immunogenicity of different formulations of GSK Biologicals H7N1 influenza vaccine in subjects 21 to 64 years of age. The study will evaluate safety related events and antibody immune responses to different formulations of study vaccine and placebo.
Primary Outcome
The following aggregate variables will be calculated: Seroconversion rates (SCR); Seroprotection rates (SPR); Mean Geometric Increase (MGI);
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Investigational H7N1 vaccine GSK2789869A
- BIOLOGICAL Investigational H7N1 vaccine GSK2789868A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 427 participants |
| Start Date | 2013-08-26 |
| Est. Completion | 2014-10-20 |
| Phase | Phase 1 |
What the finished NCT01934127 record still lists
NCT01934127 is an interventional study that assigns participants to a tested intervention. The registered 427 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 (612% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01934127 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01934127 about?
NCT01934127 is a clinical study titled "Immunogenicity and Safety Study of Different Formulations of GlaxoSmithKline (GSK) Biologicals H7N1 Influenza Vaccine Administered to Adults 21 to 64 Years of Age". The purpose of this study is to evaluate the safety and immunogenicity of different formulations of GSK Biologicals H7N1 influenza vaccine in subjects 21 to 64 years of age. The study will evaluate safety related events and antibody immune responses to different formulations of study vaccine and pla...
What is the current status of trial NCT01934127?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 427 participants. The study started on 2013-08-26. Estimated completion is 2014-10-20.
What interventions are being tested in trial NCT01934127?
The interventions under investigation include: Placebo (BIOLOGICAL), Investigational H7N1 vaccine GSK2789869A (BIOLOGICAL), Investigational H7N1 vaccine GSK2789868A (BIOLOGICAL).
Who is sponsoring clinical trial NCT01934127?
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 NCT01934127's enrollment target sits among peer trials
427 65th of 2000 higher than 1,936 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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