PARIS Sanofi said on Monday that a large clinical trial showed its Fluzone High-Dose vaccine to be more effective at preventing influenza in adults aged 65 and older than a standard dose of Fluzone.
Sanofi said it plans to submit the full clinical study report to the U.S. Food and Drug Administration for review by early 2014 and will seek to modify to the label for Fluzone High-Dose vaccine to reflect the superior efficacy data in this age group.
In the study, which included roughly 30,000 participants, Fluzone High-Dose vaccine was 24.2 percent more effective in preventing influenza in adults 65 years of age and older than Fluzone vaccine.
Fluzone High-Dose vaccine was licensed for sale by the FDA in 2009 under an accelerated approval process that included a requirement that Sanofi complete a large-scale confirmatory study.
(Reporting by Leila Abboud)