CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,350 enrolled
Drug / intervention
Flublok Quadrivalent +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.

Search/NCT02290509
NCT02290509Phase 3Completed
CompareCT.gov

Double-Blind, Randomized, Active-Controlled Comparison of the Immunogenicity and Safety of Flublok® Quadrivalent Versus IIV4 in Healthy, Medically Stable Adults 18-49 Years of Age

Protein Sciences Corporation·interventional·Posted Nov 14, 2014·Updated Oct 27, 2016

In Brief

A Phase 3 clinical trial evaluating Flublok Quadrivalent and Inactivated Influenza Vaccine (IIV4) for Influenza. Completed, enrolled 1,350 participants across 10 sites.

Detailed Summary

Randomized, double-blind trial of safety and immunogenicity of Flublok Quadrivalent versus Inactivated Influenza Vaccine (IIV4) in 1350 healthy, medically stable adults 18-49 years of age. Serum samples for Hemagglutinin Inhibition titers will be determined pre- and 28 days post-vaccination. Subjects will be followed for 6 months after vaccination for serious and/or medically-attended adverse events.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesUnited States
CollaboratorsSyneos Health, Department of Health and Human Services

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 14, 2014
Enrollment StartOct 1, 2014
Primary CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 11.6 years ago

Interventions

Flublok Quadrivalentbiological

Intramuscular injection of study vaccine

Inactivated Influenza Vaccine (IIV4)biological

Intramuscular injection of study vaccine