Sanofi's high dose Fluzone vaccine shows superior efficacy in adults over 65

French drug major Sanofi (Euronext: SAN) has released topline results of a large-scale, multicenter efficacy trial in people 65 years of age and older showing a superior clinical benefit of Fluzone High-Dose (influenza virus vaccine) relative to the standard dose of Fluzone vaccine in preventing influenza.

The results reflect the positive findings related to the primary endpoint for the study population while further data analyses of secondary endpoints are ongoing, including an evaluation of the relative efficacy based on the match of the vaccine strains to circulating influenza virus strains.

Sanofi expects to submit the full clinical study report to the US Food and Drug Administration for review by early 2014 and will seek a modification to the label for the vaccine reflecting the superior efficacy data in that age group.