CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 12,046 enrolled
Drug / intervention
Quadrivalent seasonal influenza vaccine(Flu D-QIV) GSK2321138A +4 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/NCT01439360
NCT01439360Phase 3Completed
CompareCT.gov

An Efficacy Study of GSK Biologicals' Quadrivalent Influenza Vaccine GSK2321138A (FLU D-QIV) When Administered in Children

GlaxoSmithKline·interventional·Posted Sep 23, 2011·Updated Sep 26, 2018

In Brief

A Phase 3 clinical trial evaluating Quadrivalent seasonal influenza vaccine(Flu D-QIV) GSK2321138A, Havrix Junior, and 3 other interventions for Influenza. Completed, enrolled 12,046 participants across 103 sites in 13 countries.

Detailed Summary

The purpose of this study is to evaluate the efficacy, immunogenicity and safety of GSK Biologicals' influenza candidate vaccine GSK2321138A when compared to non-influenza vaccine comparators in children 6 to 35 months of age. Recruitment will encompass at least 4 independent cohorts: a first cohort in the Northern Hemisphere (2011-2012), a second cohort in subtropical countries (2012), third cohort in the Northern Hemisphere (2012-2013) and a fourth cohort and additional independent cohorts possibly in NH countries (end 2013) and subtropical countries (beginning 2014).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesBangladesh, Belgium, Czechia, Dominican Republic, Honduras, India, Lebanon, Philippines, Poland, Spain, Thailand, Turkey (Türkiye), United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 23, 2011
Enrollment StartOct 1, 2011
Primary CompletionOct 31, 2014
Study CompletionDec 31, 2014
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 14.8 years ago

Interventions

Quadrivalent seasonal influenza vaccine(Flu D-QIV) GSK2321138Abiological

Intramuscular injection

Havrix Juniorbiological

Intramuscular injection administered to subjects aged 12 months or older

Prevenar 13biological

Intramuscular injection administered to subjects less than 12 months of age

Varivax/ProVarivaxbiological

Intramuscular injection administered to subjects more than 12 months of age

Varilrixbiological

Subcutaneous injection administered to subjects more than 12 months of age