CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 390 enrolled
Drug / intervention
GSK Biologicals' influenza vaccine GSK1557482A +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/NCT00778895
NCT00778895Phase 2Completed
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Clinical Study in Children, 6 Months to 3 Years of Age, to Assess the Immunogenicity and Safety of Two Dose Levels of Thimerosal-free Fluviral® Vaccine, Using a Licensed Influenza Virus Vaccine, Vaxigrip® as the Control

GlaxoSmithKline·interventional·Posted Oct 24, 2008·Updated Aug 17, 2018

In Brief

A Phase 2 clinical trial evaluating GSK Biologicals' influenza vaccine GSK1557482A and Vaxigrip for Influenza. Completed, enrolled 390 participants across 18 sites.

Detailed Summary

Children younger than 5 years of age are at high risk for severe influenza disease (flu) and hospitalization due to flu. Scientists are in the process of re-evaluating the dosing initially based on whole virus vaccines to improve their efficacy in infants. In this study, we will compare two different dose levels of GSK1557482A flu vaccine. Another already approved flu vaccine made by a different company will be used as a control.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesCanada
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 24, 2008
Enrollment StartNov 10, 2008
Primary CompletionAug 19, 2009
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 17.7 years ago

Interventions

GSK Biologicals' influenza vaccine GSK1557482Abiological

one IM injection at Day 0 for primed subjects (defined as subjects who had a prior 2-dose priming influenza immunization) or two IM injections at Day 0 and approximately Day 28 for un-primed subjects (defined as subjects who have not previously received a complete 2-dose priming influenza immunization).

Vaxigripbiological

one IM injection at Day 0 for primed subjects (defined as subjects who had a prior 2-dose priming influenza immunization) or two IM injections at Day 0 and approximately Day 28 for un-primed subjects (defined as subjects who have not previously received a complete 2-dose priming influenza immunization).