Phase 3 Study Update of Quadrivalent Influenza Vaccine in Pediatric Population

Sanofi Pasteur, the vaccines division of Sanofi Aventis, announced new Phase 3 data for its investigational quadrivalent influenza vaccine (QIV) in children. This pediatric study evaluated the safety and immunogenicity of QIV compared to currently licensed Fluzone(Influenza Virus Vaccine; Sanofi Pasteur); QIV contains the addition of a fourth influenza strain (a second B strain).

In this randomized, observer-blinded, active-controlled, three-arm, multicenter study, more than 4,300 children 6 months through 8 years of age were randomized approximately 4:1:1 to receive investigational QIV containing the two licensed influenza A strains plus strains from both B lineages, the 2010-2011 licensed trivalent inactivated influenza vaccine (TIV; Fluzone vaccine, containing a Victoria-lineage B strain) or TIV containing the two licensed influenza A strains plus the alternate (Yamagata) B lineage strains.

The objectives of the study included demonstration of non-inferiority of antibody responses to each influenza strain in QIV compared with responses to each respective strain in the TIV comparators. Non-inferiority was measured in children 6 months through 8 years of age for the study population overall and separately for the youngest children 6 months through 35 months of age and older children 3 years through 8 years of age. Additional objectives of the study were to demonstrate superiority of antibody responses to each B strain in QIV compared with antibody titers following vaccination with the TIV that did not contain the corresponding B strain. Immunogenicity was assessed before and 28 days post-vaccination. Safety was assessed throughout the duration of the study.

All non-inferiority criteria were met for all four strains in QIV compared with the two control TIV formulations for the study group overall and separately for children in the sub-groups 6 months through 35 months of age and 3 years through 8 years of age. Superiority criteria were met for each B strain in QIV compared with each TIV that did not contain the corresponding B strain. The safety profiles of the QIV and the TIV formulations in the study did not materially differ. Rates of unsolicited adverse events and serious adverse events were similar among the study groups.

QIV is an inactivated influenza virus vaccine being evaluated for active immunization against influenza disease caused by influenza virus subtypes A and B.

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