CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 12,794 enrolled
Drug / intervention
Quadrivalent VLP Vaccine +1 morebiological
Likely dose
Quadrivalent VLP Vaccine 30 µgfrom 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/NCT03739112
NCT03739112Phase 3Completed
CompareCT.gov

A Randomized, Observer-blind, Active Comparator-controlled, Multicenter, Phase 3 Study to Assess the Efficacy, Safety, and Immunogenicity of a Plant-derived Quadrivalent VLP Influenza Vaccine in Adults 65 Years of Age and Older

Medicago·interventional·Posted Nov 13, 2018·Updated Jun 23, 2023

In Brief

A Phase 3 clinical trial evaluating Quadrivalent VLP Vaccine and Fluarix Quadrivalent® Comparator Vaccine for Virus Diseases and 3 related conditions. Completed, enrolled 12,794 participants across 104 sites in 5 countries.

Detailed Summary

This Phase 3 study was intended to assess the relative efficacy of the Quadrivalent VLP Influenza Vaccine during the 2018-2019 influenza season compared to a licensed vaccine in elderly adults 65 years of age and older. One dose of VLP Influenza Vaccine (30 μg/strain) or of Comparator (15 μg/strain) was to be administered to 12,738 participants.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVirus Diseases, RNA Virus Infections, Respiratory Tract Diseases, Respiratory Tract Infections
CountriesCanada, Finland, Germany, Thailand, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedNov 13, 2018
Enrollment StartSep 18, 2018
Primary CompletionMay 17, 2019
Study CompletionJul 16, 2019
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 7.6 years ago

Interventions

Quadrivalent VLP Vaccinebiological

Single dose of a 30 µg/strain of Quadrivalent VLP Vaccine

Fluarix Quadrivalent® Comparator Vaccinebiological

Single dose of a 15 μg/strain of Fluarix Quadrivalent® Comparator Vaccine