At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 50 enrolled
Drug / intervention
Arepanrix™biological
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.
Immunogenicity and Safety Study of GSK Biologicals' Influenza Vaccine Arepanrix™ (GSK2340274A) in Adults 65 Years of Age or Older
In Brief
A Phase 4 clinical trial evaluating Arepanrix™ for Influenza. Completed, enrolled 50 participants across 1 site.
Detailed Summary
The purpose of this study is to comply with the post marketing condition to the exceptional approval of Arepanrix™ in Japan and to assess the immunogenicity and safety of GSK Biologicals' H1N1 influenza vaccine healthy Japanese adults 65 years of age or older.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesJapan
Collaborators--
Timeline
Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 2010
Enrollment StartMay 2010
Primary CompletionNov 2010
Study CompletionDec 2010
TodayJul 2026
First PostedMay 3, 2010
Enrollment StartMay 17, 2010
Primary CompletionNov 5, 2010
Study CompletionDec 9, 2010
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 16.2 years ago
Interventions
Arepanrix™biological
Intramuscular administration, one dose