At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 3,317 enrolled
Drug / intervention
Fluarix +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.
Immunogenicity and Safety of GSK Biologicals' Thimerosal-free TIV Flu Vaccine Versus a Licensed Comparator in Children
In Brief
A Phase 3 clinical trial evaluating Fluarix and Fluzone for Influenza. Completed, enrolled 3,317 participants across 69 sites in 5 countries.
Detailed Summary
The purpose of this study is to evaluate the immunogenicity and the safety of GlaxoSmithKline Biologicals' seasonal influenza vaccine, Fluarix, compared to Fluzone (a US-licensed vaccine) in children, 6 to 35 months of age.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesHong Kong, Mexico, Taiwan, Thailand, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2008
First PostedOct 2008
Primary CompletionMar 2009
Study CompletionJun 2009
TodayJul 2026
First PostedOct 2, 2008
Enrollment StartOct 1, 2008
Primary CompletionMar 5, 2009
Study CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 17.8 years ago
Interventions
Fluarixbiological
One (Day 0) or two (Day 0 and Day 28) doses by intramuscular injection. Two different doses are tested.
Fluzonebiological
One (Day 0) or two (Day 0 and Day 28) doses by intramuscular injection.