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NCT01949090 · ClinicalTrials.gov registry record · Phase 2
Immunogenicity and Safety Study of Different Formulations of GlaxoSmithKline (GSK) Biologicals H7N1 Influenza Vaccine Administered to Adults 65 Years of Age and Older
A Phase 2 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 363
- Enrollment target
NCT01949090: Completed Phase 2 study, sponsored by GlaxoSmithKline.
NCT01949090 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 363 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (173% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01949090, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 363 participants
- Enrollment target
Study Summary
The purpose of this placebo controlled study is to evaluate the safety and immunogenicity of different formulations of GSK Biologicals H7N1 influenza vaccine in subjects 65 years of age and older. The study will evaluate safety related events and antibody immune responses to different formulations of study vaccine.
Primary Outcome
Seroconversion was defined as: For initially seronegative subjects \[antibody titer below (\<) 10 post-vaccination\], antibody titer greater than or equal to (≥) 40 after vaccination; For initially seropositive subjects (antibody titer ≥ 10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/mallard/Netherlands/12/2000 NIBRG-63 (H7N1) (Flu A/mallard/NL/12/2000 H7N1).
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Investigational H7N1 vaccine GSK2789869A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 363 participants |
| Start Date | 2013-09-25 |
| Est. Completion | 2014-10-23 |
| Phase | Phase 2 |
What the finished NCT01949090 record still lists
NCT01949090 is an interventional study that assigns participants to a tested intervention. The registered 363 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (173% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01949090 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01949090 about?
NCT01949090 is a clinical study titled "Immunogenicity and Safety Study of Different Formulations of GlaxoSmithKline (GSK) Biologicals H7N1 Influenza Vaccine Administered to Adults 65 Years of Age and Older". The purpose of this placebo controlled study is to evaluate the safety and immunogenicity of different formulations of GSK Biologicals H7N1 influenza vaccine in subjects 65 years of age and older. The study will evaluate safety related events and antibody immune responses to different formulations o...
What is the current status of trial NCT01949090?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 363 participants. The study started on 2013-09-25. Estimated completion is 2014-10-23.
What interventions are being tested in trial NCT01949090?
The interventions under investigation include: Placebo (BIOLOGICAL), Investigational H7N1 vaccine GSK2789869A (BIOLOGICAL).
Who is sponsoring clinical trial NCT01949090?
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 NCT01949090's enrollment target sits among peer trials
363 122nd of 2000 higher than 1,879 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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