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

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.

Timeline

Start

2010-10-04

Primary completion

2011-06-15

Completion

2011-06-15

Outcome

Met primary endpoint

paper Noninferiority against shared strains and superiority against alternate-lineage B strains was demonstrated for QIV vs TIV. PMID 23470848 ↗

Publications

• Domachowske JB, Pankow-Culot H, Bautista M, Feng Y, Claeys C, Peeters M, Innis BL, Jain V. A randomized trial of candidate inactivated quadrivalent influenza vaccine versus trivalent influenza vaccines in children aged 3-17 years. J Infect Dis. 2013 Jun 15;207(12):1878-87. doi: 10.1093/infdis/jit091. Epub 2013 Mar 7.

Drugs

Indications