At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 9,003 enrolled
Drug / intervention
Flublok Quadrivalent Influenza Vaccine +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.
Comparison of the Protective Efficacy of Flublok® Quadrivalent Versus Licensed Inactivated Influenza Vaccine (IIV4) in Healthy, Medically Stable Adults ≥50 Years of Age
In Brief
A Phase 3 clinical trial evaluating Flublok Quadrivalent Influenza Vaccine and Inactivated Influenza Vaccine for Influenza. Completed, enrolled 9,003 participants across 38 sites.
Detailed Summary
The goal of this study is to establish that Flublok Quadrivalent is non-inferior to fully licensed (traditional approval status) quadrivalent inactivated influenza vaccine (IIV4) in protecting against laboratory-confirmed clinical influenza disease in the ≥50 year age population.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartOct 2014
First PostedNov 2014
Primary CompletionMay 2015
TodayJul 2026
First PostedNov 7, 2014
Enrollment StartOct 1, 2014
Primary CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 11.7 years ago
Interventions
Flublok Quadrivalent Influenza Vaccinebiological
Intramuscular injection of vaccine
Inactivated Influenza Vaccinebiological
Intramuscular injection of vaccine