CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,202 enrolled
Drug / intervention
Quadrivalent VLP Influenza Vaccinebiological
Likely dose
Quadrivalent VLP Influenza 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/NCT03321968
NCT03321968Phase 3Completed
CompareCT.gov

A Randomized, Observer-blind, Multicenter, Phase 3 Study to Evaluate the Lot Consistency, Immunogenicity, and Safety of a Plant-Derived Quadrivalent VLP Influenza Vaccine in Healthy Adults 18-49 Years of Age

Medicago·interventional·Posted Oct 26, 2017·Updated Aug 4, 2023

In Brief

A Phase 3 clinical trial evaluating Quadrivalent VLP Influenza Vaccine for Virus Diseases and 4 related conditions. Completed, enrolled 1,202 participants across 10 sites.

Detailed Summary

This Phase 3 study is intended to assess the clinical lot-to-lot consistency in manufacturing by evaluating and comparing the immunogenicity of three consecutively manufactured lots of the Quadrivalent Virus-Like Particles (VLP) Influenza Vaccine, during the 2016-2017 influenza season, in healthy adults 18-49 years of age. A single dose of one of three consecutive lots of Quadrivalent VLP Influenza Vaccine (30 µg/strain) will be administered to 1,200 participants.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVirus Diseases, RNA Virus Infections, Respiratory Tract Infections, Respiratory Tract Disease, Influenza
CountriesCanada
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedOct 26, 2017
Enrollment StartSep 29, 2017
Primary CompletionDec 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 8.7 years ago

Interventions

Quadrivalent VLP Influenza Vaccinebiological

Single dose of 30 µg/strain Quadrivalent VLP Influenza Vaccine