CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 3,109 enrolled
Drug / intervention
Quadrivalent seasonal influenza vaccine GSK2282512A +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/NCT01198756
NCT01198756Phase 3Completed
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Immunogenicity and Safety Study of GSK Biologicals' Quadrivalent Influenza Vaccine (GSK2282512A) When Administered in Children

GlaxoSmithKline·interventional·Posted Sep 10, 2010·Updated Sep 21, 2018

In Brief

A Phase 3 clinical trial evaluating Quadrivalent seasonal influenza vaccine GSK2282512A, Fluarix™ VB, and 1 other intervention for Influenza. Completed, enrolled 3,109 participants across 33 sites in 5 countries.

Detailed Summary

This study is designed to test the immunogenicity and safety of an investigational influenza vaccine, in children compared to two other influenza vaccines.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesCanada, Mexico, Spain, Taiwan, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 10, 2010
Enrollment StartOct 1, 2010
Primary CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 15.8 years ago

Interventions

Quadrivalent seasonal influenza vaccine GSK2282512Abiological

For subject 3 to 8 years of age, single intramuscular dose for primed subjects, two doses for unprimed subjects. For subjects 9 to 17 years of age, single intramuscular dose.

Fluarix™ VBbiological

For subject 3 to 8 years of age, single intramuscular dose for primed subjects, two doses for unprimed subjects. For subjects of 9 to 17 years of age, single intramuscular dose.

Fluarix™ YBbiological

For subject 3 to 8 years of age, single intramuscular dose for primed subjects, two doses for unprimed subjects. For subjects of 9 to 17 years of age, single intramuscular dose

Quadrivalent seasonal influenza vaccine GSK2282512Abiological

Single intramuscular dose for primed subjects, two doses for unprimed subjects.