CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 4,514 enrolled
Drug / intervention
QIVc +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/NCT03165617
NCT03165617Phase 3Completed

A Phase III/IV, Stratified, Randomized, Observer Blind, Multicenter Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of a Cell-Based Quadrivalent Subunit Influenza Virus Vaccine Compared to Non-Influenza Comparator Vaccine in Subjects ≥2 to <18 Years of Age

Seqirus·interventional·Posted May 24, 2017·Updated Oct 22, 2020

In Brief

A Phase 3 clinical trial evaluating QIVc and Non-influenza Comparator Vaccine for Influenza, Human. Completed, enrolled 4,514 participants across 40 sites in 8 countries.

Detailed Summary

This Phase 3/4, randomized, observer-blind, multi-center study, stratified study evaluated the immune (antibody) response, efficacy and safety of a cell-derived quadrivalent subunit influenza virus vaccine (Seqirus QIVc) in comparison with a non-influenza comparator, meningococcal serogroup A, C, W-135, and Y (Menveo®, GlaxoSmithKline Biologicals, S.A.) in healthy pediatric subjects ≥2 Years to \<18 Years of Age

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Estonia, Finland, Lithuania, Philippines, Poland, Spain, Thailand
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedMay 24, 2017
Enrollment StartMay 25, 2017
Primary CompletionSep 30, 2019
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 9.1 years ago

Interventions

QIVcbiological

Cell-derived Quadrivalent Influenza Vaccine for intramuscular use containing each of the 2 influenza type A strains and each of the 2 influenza type B strains

Non-influenza Comparator Vaccinebiological

Non-influenza comparator vaccine for intramuscular use