At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 185 enrolled
Drug / intervention
Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A).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.
An Observer-blind, Dose Ranging Safety and Immunogenicity Study of GSK Biologicals' GSK1557484A Vaccine in Children 6 to Less Than 36 Months of Age
In Brief
A Phase 2 clinical trial evaluating Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A). for Influenza. Completed, enrolled 185 participants across 7 sites in 2 countries.
Detailed Summary
The purpose of this study is to assess the safety and immunogenicity of different formulations of GSK Biologicals' influenza candidate vaccine GSK1557484A, in children 6-35 months of age.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesTaiwan, Thailand
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 2016
Enrollment StartJul 2016
Primary CompletionFeb 2018
TodayJul 2026
First PostedMar 25, 2016
Enrollment StartJul 7, 2016
Primary CompletionFeb 13, 2018
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 10.3 years ago
Interventions
Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A).biological
All subjects will receive intramuscularly a two-dose primary series (adjuvanted) at a 21 day interval, and a booster dose (unadjuvanted) at Day 385 of GSK1557484A vaccine.