At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 6,790 enrolled
Drug / intervention
MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV) +1 morebiological
Likely dose
MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV) 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 III, Randomized, Observer-Blind, Controlled, Multicenter Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Influenza Vaccine Compared to Non-influenza Vaccine Comparator in Adults ≥ 65 Years of Age
In Brief
A Phase 3 clinical trial evaluating MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV) and Non-Influenza Comparator (Boostrix) for Influenza. Completed, enrolled 6,790 participants across 89 sites in 12 countries.
Detailed Summary
A Phase III, Randomized, Observer-Blind, Controlled, Multicenter Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Influenza Vaccine Compared to Non-influenza Vaccine Comparator in Adults ≥ 65 Years of Age.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesBulgaria, Colombia, Czechia, Estonia, Latvia, Lithuania, Malaysia, Philippines, Poland, Romania, Thailand, Turkey (Türkiye)
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 2015
Enrollment StartSep 2016
Primary CompletionJul 2018
TodayJul 2026
First PostedOct 27, 2015
Enrollment StartSep 30, 2016
Primary CompletionJul 23, 2018
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 10.7 years ago
Interventions
MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV)biological
1 dose approximately 0.5 mL of aQIV
Non-Influenza Comparator (Boostrix)biological
1 dose approximately 0.5 mL dose of Non-influenza comparator vaccine (Boostrix)