At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 470 enrolled
Drug / intervention
Fluarix Quadrivalentbiological
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, Safety and Reactogenicity Study of GSK Biologicals' Quadrivalent Seasonal Influenza Candidate Vaccine GSK2321138A, Administered to Children Who Previously Participated in Study 115345
In Brief
A Phase 3 clinical trial evaluating Fluarix Quadrivalent for Influenza. Completed, enrolled 470 participants across 33 sites in 4 countries.
Detailed Summary
The purpose of this study is to assess the safety and immunogenicity of GSK Biologicals' investigational vaccine GSK2321138A in children who previously participated in study 115345 (FLU D-QIV-004 PRI) (NCT01439360).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesCzechia, Poland, Spain, United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2012
First PostedOct 2012
Primary CompletionMay 2013
Study CompletionJun 2013
TodayJul 2026
First PostedOct 8, 2012
Enrollment StartOct 6, 2012
Primary CompletionMay 6, 2013
Study CompletionJun 5, 2013
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 13.7 years ago
Interventions
Fluarix Quadrivalentbiological
1 or 2 doses administered intramuscularly (IM) in deltoid region depending on the priming status