CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 520 enrolled
Drug / intervention
Influenza vaccine GSK1562902A Formulation 1 +3 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/NCT01379937
NCT01379937Phase 3Completed
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Safety and Immunogenicity Study of a Prime-boost Schedule of GSK Biologicals' Influenza Vaccine GSK1562902A in Children Aged 3 to 17 Years

GlaxoSmithKline·interventional·Posted Jun 23, 2011·Updated Sep 7, 2018

In Brief

A Phase 3 clinical trial evaluating Influenza vaccine GSK1562902A Formulation 1, Influenza vaccine GSK1562902A Formulation 2, and 2 other interventions for Influenza. Completed, enrolled 520 participants across 2 sites.

Detailed Summary

The purpose of this study is to assess the safety and immunogenicity of a prime-boost schedule of GSK Biologicals' influenza vaccine in children aged 3 to 17 years.

Study Details

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

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 23, 2011
Enrollment StartJul 28, 2011
Primary CompletionAug 2, 2012
Study CompletionOct 5, 2012
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 15.0 years ago

Interventions

Influenza vaccine GSK1562902A Formulation 1biological

Intramuscular injection, two doses each in GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 1 - Havrix / Havrix Jr Group

Influenza vaccine GSK1562902A Formulation 2biological

Intramuscular injection, one dose each in GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group

Havrix™biological

Intramuscular injection, one dose in GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and two doses each in GSK1562902A Formulation 1 - Havrix / Havrix Jr Group, GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and Havrix / Havrix Jr Group

Havrix™ Juniorbiological

Intramuscular injection, one dose in GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and two doses each in GSK1562902A Formulation 1 - Havrix / Havrix Jr Group,GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and Havrix / Havrix Jr Group