CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 6,154 enrolled
Drug / intervention
GSK Biologicals' investigational vaccine GSK2340274A (alternative formulations) +2 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/NCT01051661
NCT01051661Phase 3Completed
CompareCT.gov

A Study to Evaluate the Safety and Efficacy of A/California/7/2009 (H1N1)V-like Vaccines GSK2340274A and GSK2340273A in Children Aged 6 Months to Less Than 10 Years of Age

GlaxoSmithKline·interventional·Posted Jan 18, 2010·Updated Feb 26, 2021

In Brief

A Phase 3 clinical trial evaluating GSK Biologicals' investigational vaccine GSK2340274A (alternative formulations), GSK Biologicals' investigational vaccine GSK2340273A (alternative formulations), and 1 other intervention for Influenza. Completed, enrolled 6,154 participants across 17 sites in 8 countries.

Detailed Summary

The purpose of this study is to characterize the safety and efficacy of GSK Biologicals' H1N1 flu candidate vaccines GSK2340274A and GSK2340273A in children 6 months to less than 10 years of age.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesAustralia, Brazil, Colombia, Costa Rica, Mexico, Philippines, Singapore, Thailand
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 18, 2010
Enrollment StartFeb 12, 2010
Primary CompletionAug 31, 2011
Study CompletionSep 9, 2011
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 16.5 years ago

Interventions

GSK Biologicals' investigational vaccine GSK2340274A (alternative formulations)biological

Intramuscular injection, one or two doses

GSK Biologicals' investigational vaccine GSK2340273A (alternative formulations)biological

Intramuscular injection, two doses

Placebobiological

Intramuscular injection, one dose