At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 3,124 enrolled
Drug / intervention
Candidate Influenza Vaccine GSK1247446A - 3 different formulations +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.
Demonstrate the Lot-to-lot Consistency of 3 Consecutive Production Lots of an Adjuvanted Influenza Vaccine Candidate and Evaluate the Safety of an Adjuvanted Influenza Vaccine Candidate Versus Fluarix™ Administered Intramuscularly in Elderly
In Brief
A Phase 2 clinical trial evaluating Candidate Influenza Vaccine GSK1247446A - 3 different formulations and Fluarix TM for Influenza. Completed, enrolled 3,124 participants across 46 sites in 7 countries.
Detailed Summary
The purpose of this phase IIb study is to demonstrate the consistency of three lots of an adjuvanted influenza vaccine candidate and to evaluate the safety of this vaccine compared to Fluarix™ administered intramuscularly in elderly aged 60 years old and above.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesEstonia, France, Germany, Greece, Norway, Russia, United Kingdom
Collaborators--
Timeline
Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2006
First PostedMay 2006
Primary CompletionJul 2006
Study CompletionJul 2006
TodayJul 2026
First PostedMay 4, 2006
Enrollment StartApr 27, 2006
Primary CompletionJul 1, 2006
Study CompletionJul 7, 2006
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 20.2 years ago
Interventions
Candidate Influenza Vaccine GSK1247446A - 3 different formulationsbiological
Single dose, Intramuscular injection
Fluarix TMbiological
Single dose, Intramuscular injection