New phase III pediatric influenza vaccine data presented

Sanofi Pasteur, the vaccines division of the global and diversified healthcare company Sanofi, announced new phase III data on Tuesday for its investigational quadrivalent influenza vaccine for children.

The study, which evaluated the immunogenicity and safety of QIV in children six months through eight years of age, found that adding a fourth influenza strain to the vaccine does not adversely affect its immunogenicity and safety profiles when compared to currently licensed Fluzone. Sanofi presented the results in Boston at the Annual Meeting of the Pediatric Academy Societies.

"Fluzone vaccine is the only influenza vaccine licensed and available in the U.S. for use in children as young as six months of age along with formulations of Fluzone vaccine available for the full spectrum of the population through the oldest adults," David Greenberg, the senior director of U.S. Scientific and Medical Affairs at Sanofi Pasteur, said. "We believe that a quadrivalent Fluzone vaccine could provide an important public health benefit for people of all ages by providing coverage against an extra B virus strain of influenza. Influenza B is responsible for a substantial burden of disease and influenza-associated complications and hospitalizations in children."

The annual trivalent inactivated influenza formulation includes one B strain and two A strains. Two distinct influenza B lineages have co-circulated with varying prevalence for more than a decade, making it difficult to guess which B-lineage strain will be prominent in a given year. The study found that the safety profiles between the QIV and the TIV formulations did not differ materially. All non-inferiority criteria were met for all four strains in QIV when compared to the two TIV control formulations for the overall study group.