At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 1,006 enrolled
Drug / intervention
Influenza Vaccine GSK1247446A - 4 different formulations +1 morebiological
Likely dose
Not stated in record
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Immunogenicity, Safety and Reactogenicity of GSK Biologicals' Influenza Vaccine GSK1247446A With Various Formulations in Subjects Aged 18-64 Years
In Brief
A Phase 2 clinical trial evaluating Influenza Vaccine GSK1247446A - 4 different formulations and Fluarix™ for Influenza. Completed, enrolled 1,006 participants across 15 sites in 3 countries.
Detailed Summary
In order to find the formulation leading to a maximal increase of the immune response while maintaining an acceptable safety profile, this study is designed to evaluate the immunogenicity, safety and reactogenicity of the different formulations of GSK Biologicals' influenza vaccine administered in adults aged 18-64 years.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesFrance, Germany, Spain
Collaborators--
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 2007
Enrollment StartOct 2007
Primary CompletionMay 2008
TodayJul 2026
First PostedOct 5, 2007
Enrollment StartOct 5, 2007
Primary CompletionMay 8, 2008
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 18.7 years ago
Interventions
Influenza Vaccine GSK1247446A - 4 different formulationsbiological
Single dose, Intramuscular injection
Fluarix™biological
Single dose, Intramuscular injection