French drugmaker Sanofi (SNYNF, SNY) Monday said its multi-center efficacy trial of Fluzone High-Dose Influenza Virus Vaccine in people 65 years of age and older met primary endpoint of superior efficacy.
Sanofi Pasteur, the company's vaccines division, said topline results of a large-scale, multi-center efficacy trial showed a superior clinical benefit of Fluzone High-Dose relative to the standard dose of Fluzone vaccine in preventing influenza.
Further data analyses of secondary endpoints are in progress, including an evaluation of the relative efficacy based on the match of the vaccine strains to circulating influenza virus strains.
David Greenberg, M.D., Vice President, U.S. Scientific and Medical Affairs, Sanofi Pasteur, said, "This efficacy trial complements the previous evidence of superior immune responses for Fluzone High-Dose vaccine compared to Fluzone vaccine and reaffirms the Phase III safety data in this population that were the basis for FDA licensure of Fluzone High-Dose vaccine in 2009."
According to the company, influenza vaccines have been shown to offer public health benefits in preventing influenza and its complications in all age groups. But, older adults still have the highest rates of influenza-related hospitalization and death despite high immunization rates.
Sanofi Pasteur expects to submit the full clinical study report to the FDA for review by early 2014. The drugmaker will seek a modification to the label for Fluzone High-Dose vaccine reflecting the superior efficacy data in adults 65 years of age and older.
Fluzone High-Dose vaccine was found 24.2 percent more effective in preventing influenza in adults 65 years of age and older than Fluzone vaccine. Additionally, the study results suggested consistent clinical benefit across the study years, influenza virus types, clinical illness definitions, and laboratory methods of influenza confirmation.
This trial also reaffirmed the safety of Fluzone High-Dose vaccine as demonstrated in previous studies. Fluzone High-Dose vaccine was licensed in the U.S. by the Food and Drug Administration in December 2009 based on the vaccine's safety profile and superior immunogenicity compared to Fluzone vaccine.
Sanofi is up 1.2 percent in early morning trade at 75.85 euros.
For comments and feedback: editorial@rttnews.com