drugset / Trial / NCT00985790

Immunogenicity and Safety Study of a GlaxoSmithKline Biologicals' Candidate Influenza Vaccine in Healthy Children

NCT00985790 ↗

Phase 2 Completed 599 enrolled GlaxoSmithKline
RandomizedParallel-groupTriple-blindPrevention

Summary

The purpose of the present study is to assess the immunogenicity and safety of vaccine GSK2321138A in children.

Timeline

Start
2009-10-08
Primary completion
2010-05-21
Completion
2010-05-21

Outcome

Met primary endpoint

paper Non-inferiority for shared strains and superiority for the alternate-lineage B strain unique to QIV was demonstrated for QIV versus TIV. PMID 25386965 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Fluarix Vaccine — Intramuscular
Subject GSK2321138A Vaccine — Intramuscular

Indications