CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 5,723 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/NCT03932682
NCT03932682Phase 3Completed

A Phase 3, Randomized, Observer-blind, Multicenter Study to Evaluate the Efficacy, Immunogenicity and Safety of Seqirus' Cell-Based Quadrivalent Subunit Influenza Virus Vaccine (QIVc) Compared to a Non-Influenza Vaccine When Administrated in Healthy Subjects Aged 6 Months Through 47 Months

Seqirus·interventional·Posted May 1, 2019·Updated Mar 4, 2025

In Brief

A Phase 3 clinical trial evaluating QIVc and Comparator for Influenza, Human. Completed, enrolled 5,723 participants across 74 sites in 15 countries.

Detailed Summary

This phase 3 clinical study is a randomized, observer-blind, multicenter study of QIVc versus a non-influenza vaccine in subjects 6 months though 47 months of age. The purpose of this study is to evaluate efficacy of QIVc in the prevention of laboratory confirmed influenza A or B disease in children 6 through 47 months of age, compared to a non-influenza vaccine.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBangladesh, Bulgaria, Czechia, Estonia, Honduras, Latvia, Malaysia, New Zealand, Pakistan, Philippines, Poland, Romania, South Africa, Thailand, Ukraine
Collaborators--

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedMay 1, 2019
Enrollment StartMay 13, 2019
Primary CompletionNov 30, 2023
Study CompletionFeb 13, 2024
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 7.2 years ago

Interventions

QIVcbiological

QIVc is a quadrivalent vaccine and contains 2 influenza type A strains and 2 influenza type B lineages recommended by World Health Organization (WHO) for inclusion in the quadrivalent vaccine formulation for the influenza season corresponding to the season of conduct of study.

Comparatorbiological

Meningococcal Group C Polysaccharide Conjugate Vaccine (NeisVac-C)