At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 842 enrolled
Drug / intervention
Influenza A (H5N1) Virus monovalent vaccine +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.
Safety and Immunogenicity of Monovalent H5N1 Vaccine GSK1557484A in Children 6 Months to < 18 Years of Age
In Brief
A Phase 3 clinical trial evaluating Influenza A (H5N1) Virus monovalent vaccine and Saline placebo for Influenza and Influenza Vaccines. Completed, enrolled 842 participants across 17 sites in 3 countries.
Detailed Summary
This study will assess safety and immunogenicity of GSK Biologicals' H5N1 flu candidate vaccine GSK1557484A in children 6 months to \< 18 years of age.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza, Influenza Vaccines
CountriesCanada, Thailand, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2011
First PostedMar 2011
Primary CompletionJul 2011
Study CompletionJan 2014
TodayJul 2026
First PostedMar 8, 2011
Enrollment StartMar 7, 2011
Primary CompletionJul 21, 2011
Study CompletionJan 26, 2014
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 15.3 years ago
Interventions
Influenza A (H5N1) Virus monovalent vaccinebiological
All subjects will receive 2 doses administered as an intramuscular (IM) injection.
Saline placebobiological
All subjects will receive 2 doses administered as an intramuscular (IM) injection.