At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 5,220 enrolled
Drug / intervention
FluLaval® Quadrivalent +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.
Efficacy Study of GSK Biologicals' Quadrivalent Influenza Vaccine, GSK2282512A, (FLU Q-QIV) When Administered in Children
In Brief
A Phase 3 clinical trial evaluating FluLaval® Quadrivalent and Havrix™ for Influenza. Completed, enrolled 5,220 participants across 12 sites in 8 countries.
Detailed Summary
This study is designed to test the efficacy of an investigational influenza vaccine, in children compared to Havrix®, a licensed Hepatitis A virus vaccine. This study will also evaluate the immunogenicity and safety of the investigational vaccine.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesBangladesh, Dominican Republic, Honduras, Lebanon, Panama, Philippines, Thailand, Turkey (Türkiye)
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 2010
Enrollment StartDec 2010
Primary CompletionJan 2012
TodayJul 2026
First PostedOct 11, 2010
Enrollment StartDec 9, 2010
Primary CompletionJan 9, 2012
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 15.7 years ago
Interventions
FluLaval® Quadrivalentbiological
One intramuscular dose for primed subjects. Two intramuscular doses for unprimed subjects.
Havrix™biological
Two intramuscular doses for primed subjects. Three intramuscular doses for unprimed subjects.