At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 4,659 enrolled
Drug / intervention
Influenza vaccine GSK2321138A +2 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.
Partially-blind Immunogenicity and Safety Study of GSK Biologicals' Seasonal Influenza Vaccine GSK2321138A in Adults.
In Brief
A Phase 3 clinical trial evaluating Influenza vaccine GSK2321138A, FluarixTM, and 1 other intervention for Influenza. Completed, enrolled 4,659 participants across 42 sites in 6 countries.
Detailed Summary
This study is designed to assess the safety and immunogenicity of a GSK Biologicals' investigational vaccine GSK2321138A in adults 18 years old and older. This study is also designed to assess the lot-to-lot consistency of vaccine GSK2321138A. The blinding will be double blind for all groups except for the GSK2604409A Group which will be open.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesGermany, Romania, South Korea, Spain, Taiwan, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 2010
Enrollment StartOct 2010
Primary CompletionJun 2011
TodayJul 2026
First PostedSep 17, 2010
Enrollment StartOct 4, 2010
Primary CompletionJun 6, 2011
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 15.8 years ago
Interventions
Influenza vaccine GSK2321138Abiological
One intramuscular injection
FluarixTMbiological
One intramuscular injection
Influenza vaccine GSK2604409Abiological
One intramuscular injection