At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 50 enrolled
Drug / intervention
Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia)biological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety and Tolerability of GSK 1557484A Vaccine in Adults at Occupational Risk for Influenza A (H5N1) Exposure
In Brief
A Phase 3 clinical trial evaluating Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) for Influenza and Influenza Vaccines. Completed, enrolled 50 participants across 3 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza, Influenza Vaccines
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 2013
Enrollment StartMar 2013
Primary CompletionMar 2014
Study CompletionFeb 2015
TodayJul 2026
First PostedFeb 11, 2013
Enrollment StartMar 22, 2013
Primary CompletionMar 27, 2014
Study CompletionFeb 25, 2015
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 13.4 years ago
Interventions
Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia)biological
2 doses administered intramuscularly (IM) in deltoid region of arm at the Day 0 and Day 21 visits.