At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 526 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 Safety and Immunogenicity Study of GlaxoSmithKline Biologicals' Influenza Vaccine GSK2186877A When Administered to Elderly Subjects.
In Brief
A Phase 3 clinical trial evaluating GSK Bio's influenza vaccine GSK2186877A and Fluarix for Influenza. Completed, enrolled 526 participants across 25 sites in 3 countries.
Detailed Summary
The purpose of this study is to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' influenza vaccine GSK2186877A in adults 65 year of age and older. This protocol posting deals with objectives \& outcome measures of the extension phase at year 1. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = 00540592).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesGermany, Netherlands, Sweden
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 2008
Enrollment StartOct 2008
Primary CompletionMay 2009
TodayJul 2026
First PostedSep 26, 2008
Enrollment StartOct 6, 2008
Primary CompletionMay 15, 2009
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 17.8 years ago
Interventions
GSK Bio's influenza vaccine GSK2186877Abiological
Intramuscular (IM) administration, 1 dose
Fluarixbiological
Intramuscular (IM) administration, 1 dose