At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 43,695 enrolled
Drug / intervention
GSK Bio's influenza vaccine GSK2186877A +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.
Observer-blind Superior Efficacy Trial With GlaxoSmithKline Biologicals' Influenza Vaccine GSK2186877A in Elderly Subjects
In Brief
A Phase 3 clinical trial evaluating GSK Bio's influenza vaccine GSK2186877A and Fluarix TM for Influenza. Completed, enrolled 43,695 participants across 274 sites in 15 countries.
Detailed Summary
The purpose of this study is to evaluate the efficacy of GlaxoSmithKline Biologicals' influenza vaccine GSK2186877A in adults 65 year of age and older. The study design is divided in two surveillance phases: one passive phase along the study during the influenza season and one active surveillance phase during the influenza peak season.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesBelgium, Canada, Czechia, Estonia, France, Germany, Mexico, Netherlands, Norway, Poland, Romania, Russia, Taiwan, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2008
First PostedSep 2008
Primary CompletionJun 2010
Study CompletionJan 2011
TodayJul 2026
First PostedSep 16, 2008
Enrollment StartSep 15, 2008
Primary CompletionJun 18, 2010
Study CompletionJan 5, 2011
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 17.8 years ago
Interventions
GSK Bio's influenza vaccine GSK2186877Abiological
IM administration, two times one annual dose, 3 different lots will be tested
Fluarix TMbiological
IM administration, two times one annual dose