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NCT01788228 · ClinicalTrials.gov registry record · Phase 3
Safety and Tolerability Study of GlaxoSmithKline (GSK)1557484A Vaccine in Adults at Occupational Risk for Influenza A (H5N1) Exposure
A Phase 3 study of Influenza and Influenza Vaccines, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 50
- Enrollment target
- 3
- Study locations
NCT01788228: Completed Phase 3 study of Influenza and Influenza Vaccines, sponsored by GlaxoSmithKline.
NCT01788228 is a Phase 3 study of Influenza and Influenza Vaccines that has completed, run by GlaxoSmithKline. The registered enrollment target is 50 participants, below the 36,804-participant average among 156 other Influenza trials with a reported enrollment target (100% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01788228, a Phase 3 study of Influenza and Influenza Vaccines, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 50 participants
- Enrollment target
- 3
- Study locations
Study Summary
The purpose of this study is to evaluate the safety and tolerability of GSK Biologicals' vaccine GSK1557484A against pandemic avian (H5N1) influenza in adults at occupational risk of exposure to the virus.
Primary Outcome
Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as significant pain at rest that prevented normal everyday activities. Grade 3 redness and swelling was greater than 100 millimeters (mm) i.e. \>100mm.
Conditions Studied
Interventions
- BIOLOGICAL Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia)
Study Locations (3)
Georgia
- GSK Investigational Site - Stockbridge
Maryland
- GSK Investigational Site - Rockville
Wisconsin
- GSK Investigational Site - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2013-03-22 |
| Est. Completion | 2015-02-25 |
| Phase | Phase 3 |
What the finished NCT01788228 record still lists
NCT01788228 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 36,804-participant average among 156 other Influenza trials with a reported enrollment target (100% lower).
The record links to 2 conditions, with Influenza appearing as the primary indexed condition, and to 1 intervention - of which Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) is the first listed.
NCT01788228 reports a single indexed study location in Georgia, Maryland, Wisconsin.
Frequently Asked Questions
What is clinical trial NCT01788228 about?
NCT01788228 is a clinical study titled "Safety and Tolerability Study of GlaxoSmithKline (GSK)1557484A Vaccine in Adults at Occupational Risk for Influenza A (H5N1) Exposure". The purpose of this study is to evaluate the safety and tolerability of GSK Biologicals' vaccine GSK1557484A against pandemic avian (H5N1) influenza in adults at occupational risk of exposure to the virus.
What is the current status of trial NCT01788228?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 50 participants. The study started on 2013-03-22. Estimated completion is 2015-02-25.
What conditions does trial NCT01788228 study?
This clinical trial studies the following conditions: Influenza, Influenza Vaccines.
What interventions are being tested in trial NCT01788228?
The interventions under investigation include: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01788228?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01788228 being conducted?
This trial has 3 study locations across Georgia, Maryland, Wisconsin. 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 NCT01788228's enrollment target sits among peer trials
50 129th of 156 higher than 25 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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