CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 606 enrolled
Drug / intervention
Quadrivalent influenza GSK2282512A vaccine +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/NCT01711736
NCT01711736Phase 3Completed
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Immunogenicity and Safety Study of GSK Biologicals' Quadrivalent Influenza Vaccine (GSK2282512A) When Administered in Children

GlaxoSmithKline·interventional·Posted Oct 22, 2012·Updated Nov 1, 2021

In Brief

A Phase 3 clinical trial evaluating Quadrivalent influenza GSK2282512A vaccine and Fluarix for Influenza. Completed, enrolled 606 participants across 8 sites in 3 countries.

Detailed Summary

The purpose of this study is to investigate the immunogenicity, reactogenicity and safety of the new influenza vaccine GSK2282512A (FLU-Q-QIV) and compare its activity to the marketed vaccine Fluarix® (TIV) in young children 6 to 35 months of age.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesCanada, Dominican Republic, Honduras
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 22, 2012
Enrollment StartNov 1, 2012
Primary CompletionFeb 21, 2013
Study CompletionJun 19, 2013
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 13.7 years ago

Interventions

Quadrivalent influenza GSK2282512A vaccinebiological

1 or 2 doses administered intramuscularly (IM) in deltoid muscle or anterolateral thigh on Day 0 (primed subjects) and on Day 0 and Day 28 (unprimed subjects) respectively.

Fluarixbiological

1 or 2 doses administered IM in deltoid muscle or anterolateral thigh, on Day 0 (primed subjects) and on Day 0 and Day 28 (unprimed subjects) respectively.