This Phase 3 study is designed to assess the safety and immunogenicity of GlaxoSmithKline (GSK) Biologicals' investigational vaccine (Fluarix) GSK2321138A in children aged 3 to 17 years and to describe the safety and immunogenicity of the GSK Biologicals' investigational vaccine in 3,027 children aged 6 to 35 months.

Results

The Journal of Infectious Disease published the results of this clinical trial on June 15, 2013.

Results: Noninferiority against shared strains and superiority against alternate-lineage B strains was demonstrated for QIV vs TIV. QIV was highly immunogenic; seroconversion rates were 91.4%, 72.3%, 70.0%, and 72.5% against A/H1N1, A/H3N2, B/Victoria, and B/Yamagata, respectively. Reactogenicity and safety of QIV was consistent with TIV.

Conclusions: QIV vs TIV showed superior immunogenicity for the additional B strain without interfering with immune responses to shared strains. QIV may offer improved protection against influenza B in children compared with current trivalent vaccines.