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May 2, 2012

Sanofi Pasteur’s Quadrivalent Flu Vaccine Succeeds in Phase III Pediatric Study

  • Sanofi Pasteur reported positive data from a Phase III study comparing its quadrivalent influenza vaccine (QIV) to the firm’s approved trivalent vaccine Fluzone®, in infants and children aged 6 months to 8 years. The trial included over 4,300 children, and demonstrated the noninferiority of QIV when compared with vaccination using either the licensed trivalent inactivated vaccine (TIV) Fluzone, which contains two influenza A strains and the Victoria-lineage B strain, or a TIV containing the two licensed A strains plus the alternate (Yamagata) B lineage strain.

    Seasonal trivalent influenza vaccines currently contain two A strains and one B strain, but two distinct B lineage strains have co-circulated over the last decade with varying prevlance, which makes it hard to predict which will predominate in a given year, Sanofi Pasteur explains. Moreover, the firm claims, about 50% of the time the B-lineage strain selected for the annual vaccine hasn’t matched the strain predominating during that season.

    “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,” comments David Greenberg, M.D., senior director for U.S. scientific and medical affairs at Sanofi Pasteur. “Influenza B is responsible for a substantial burden of disease and influenza-associated complications and hospitalizations in children.” 



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