CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 316 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/NCT01974895
NCT01974895Phase 2Completed
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Immunogenicity and Safety Study of GSK Biologicals' Quadrivalent Influenza Vaccine (GSK2282512A) in Children 6 to 35 Months of Age

GlaxoSmithKline·interventional·Posted Nov 4, 2013·Updated Sep 7, 2018

In Brief

A Phase 2 clinical trial evaluating FluLaval® Quadrivalent and Fluzone® for Influenza. Completed, enrolled 316 participants across 12 sites.

Detailed Summary

The purpose of this study is to evaluate the immunogenicity and safety of the new influenza vaccine GSK2282512A (FLU Q-QIV) and compare its activity to Sanofi Pasteur's Fluzone® (TIV) in children 6 to 35 months of age.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 4, 2013
Enrollment StartOct 23, 2013
Primary CompletionFeb 27, 2014
Study CompletionJul 3, 2014
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 12.7 years ago

Interventions

FluLaval® Quadrivalentbiological

1 or 2 doses administered intramuscularly (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®biological

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.