At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 2,044 enrolled
Drug / intervention
aQIV +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.
A Phase 3, Randomized, Observer-blind, Controlled, Multicenter, Clinical Study to Evaluate Immunogenicity and Safety of an MF59-adjuvanted Quadrivalent Subunit Inactivated Influenza Vaccine in Comparison With a Licensed Quadrivalent Influenza Vaccine, in Adults 50 to 64 Years of Age
In Brief
A Phase 3 clinical trial evaluating aQIV and Comparator QIV for Influenza, Human. Completed, enrolled 2,044 participants across 29 sites in 3 countries.
Detailed Summary
This Phase 3 study is a randomized, observer-blind immunogenicity and safety study of aQIV (an MF59-adjuvanted quadrivalent influenza vaccine) compared with a licensed quadrivalent influenza vaccine in adults 50 to 64 years of age.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza, Human
CountriesEstonia, Germany, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20222023202420252026
First PostedSep 2021
Enrollment StartSep 2021
Primary CompletionJan 2022
Study CompletionSep 2022
TodayJul 2026
First PostedSep 14, 2021
Enrollment StartSep 30, 2021
Primary CompletionJan 18, 2022
Study CompletionSep 9, 2022
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 4.8 years ago
Interventions
aQIVbiological
Participants receive a 0.5-mL intramuscular dose of aQIV on Day 1
Comparator QIVbiological
Participants receive a 0.5-mL intramuscular dose of Comparator QIV on Day 1