CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 3,027 enrolled
Drug / intervention
Influenza vaccine GSK2321138A +2 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/NCT01196988
NCT01196988Phase 3Completed
CompareCT.gov

Immunogenicity and Safety Study of GSK Biologicals' Influenza Vaccine GSK2321138A When Administered in Children

GlaxoSmithKline·interventional·Posted Sep 9, 2010·Updated Sep 21, 2018

In Brief

A Phase 3 clinical trial evaluating Influenza vaccine GSK2321138A, FluarixTM, and 1 other intervention for Influenza. Completed, enrolled 3,027 participants across 59 sites in 5 countries.

Detailed Summary

This study is designed to assess the safety and immunogenicity of GlaxoSmithKline (GSK) Biologicals' investigational vaccine GSK2321138A in children aged 3 to 17 years, and to describe safety and immunogenicity of the GSK Biologicals' investigational vaccine GSK2321138A in children aged 6 to 35 months.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesCzechia, France, Germany, Philippines, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 9, 2010
Enrollment StartOct 4, 2010
Primary CompletionJun 15, 2011
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 15.8 years ago

Interventions

Influenza vaccine GSK2321138Abiological

intramuscular injections

FluarixTMbiological

intramuscular injections

Influenza vaccine GSK2604409Abiological

intramuscular injections