At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 1,268 enrolled
Drug / intervention
CSL Limited Influenza Virus Vaccine (Afluria®) +1 morebiological
Likely dose
CSL Limited Influenza Virus Vaccine (Afluria®) 0.5 mLfrom 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.
A Phase IV, Randomized, Observer-Blind, Multi-Center, Non Inferiority Comparison of the Immune Response of CSL Limited's Influenza Virus Vaccine Compared to a US Licensed Inactivated Split-Virion Influenza Vaccine in Adults Aged Greater Than or Equal to 65 Years
In Brief
A Phase 4 clinical trial evaluating CSL Limited Influenza Virus Vaccine (Afluria®) and US Licensed Influenza Virus Vaccine (Fluzone®) for Influenza. Completed, enrolled 1,268 participants across 13 sites.
Detailed Summary
The purpose of this study is to determine the immunogenicity and safety profile of CSL Limited's Influenza Virus Vaccine compared to a US Licensed Comparator Influenza Virus Vaccine.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 2008
Enrollment StartOct 2008
Primary CompletionJan 2009
Study CompletionJun 2009
TodayJul 2026
First PostedAug 15, 2008
Enrollment StartOct 1, 2008
Primary CompletionJan 1, 2009
Study CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 17.9 years ago
Interventions
CSL Limited Influenza Virus Vaccine (Afluria®)biological
A single 0.5 mL, intramuscular injection in the deltoid region of the arm on day 0.
US Licensed Influenza Virus Vaccine (Fluzone®)biological
A single 0.5 mL, intramuscular injection in the deltoid region of the arm on day 0.