CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,432 enrolled
Drug / intervention
FluLaval™ Quadrivalent +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/NCT02242643
NCT02242643Phase 3Completed
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Immunogenicity and Safety Study of GSK Biologicals' Quadrivalent Influenza Vaccine (GSK2282512A) Compared to Fluzone® Quadrivalent in Children 6 to 35 Months of Age

GlaxoSmithKline·interventional·Posted Sep 17, 2014·Updated Sep 7, 2018

In Brief

A Phase 3 clinical trial evaluating FluLaval™ Quadrivalent and Fluzone® Quadrivalent for Influenza. Completed, enrolled 2,432 participants across 66 sites in 2 countries.

Detailed Summary

The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals' quadrivalent influenza vaccine (GSK2282512A) compared to Sanofi Pasteur's Fluzone® Quadrivalent in children 6 to 35 months of age.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesMexico, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 17, 2014
Enrollment StartOct 1, 2014
Primary CompletionMar 16, 2015
Study CompletionJun 23, 2015
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 11.8 years ago

Interventions

FluLaval™ Quadrivalentbiological

1 or 2 doses administered intramusculary (IM) in deltoid region of non-dominant arm (for subjects ≥12 months of age) or anterolateral region of left thigh (for subjects \<12 months of age) on Day 0 (primed subjects) and on Day 0 and Day 28 (unprimed subjects), respectively

Fluzone® Quadrivalentbiological

1 or 2 doses administered IM in deltoid region of non-dominant arm (for subjects ≥12 months of age) or anterolateral region of left thigh (for subjects \<12 months of age) on Day 0 (primed subjects) and on Day 0 and Day 28 (unprimed subjects), respectively