At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 4,561 enrolled
Drug / intervention
Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted +1 morebiological
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.
A Trial to Evaluate the Safety and Immunogenicity of an Investigational Vaccination Regimen in Adults Aged ≥18 Years
In Brief
A Phase 3 clinical trial evaluating Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted and Placebo for Influenza. Completed, enrolled 4,561 participants across 40 sites in 2 countries.
Detailed Summary
The purpose of this Phase 3, observer-blind, placebo-controlled, multi-center study is to characterize the immunogenicity \& safety of the investigation vaccination regimen of GSK 1557484A vaccine given to adults aged ≥18 years.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesCanada, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2008
First PostedFeb 2008
Primary CompletionOct 2008
Study CompletionMar 2009
TodayJul 2026
First PostedFeb 15, 2008
Enrollment StartJan 23, 2008
Primary CompletionOct 15, 2008
Study CompletionMar 19, 2009
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 18.4 years ago
Interventions
Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvantedbiological
Two intramuscular injections at Days 0 and 21.
Placebobiological
Two intramuscular injections at Days 0 and 21.