Fluzone vac for adults above 65 years in USJanuary 6, 2020
Fluzone High-Dose Quadrivalent has been granted for use in adults 65 years of age and older in the US. The quadrivalent vaccine is given to people 65 years of age and older to help prevent influenza disease caused by influenza A and B strains contained in the vaccine.
FDA approval was based on data from a phase 3 immunogenicity and safety study, in which Fluzone High-Dose Quadrivalent achieved the primary endpoint of non-inferior immunogenicity compared to two trivalent formulations of Fluzone High-Dose, each containing one of the two influenza B strains recommended for inclusion in the vaccine for the 2017-2018 influenza season.
In a secondary endpoint of the trial, each B strain in Fluzone High-Dose Quadrivalent induced a superior immune response compared to the trivalent formulation not containing the corresponding B strain.
Rates of local and systemic reactions that occurred following immunization with Fluzone High-Dose Quadrivalent were similar to those induced by trivalent formulations of Fluzone High-Dose.
Fluzone High-Dose is the first and only influenza vaccine proven to provide superior efficacy compared to Fluzone in adults 65 years of age and older, based on results in a randomised controlled trial.
This study evaluated nearly 32,000 adults 65 years of age and older over two influenza seasons in the US and Canada. Results showed that Fluzone High-Dose prevented 24 percent more cases of influenza caused by any circulating influenza strain and 51 percent more cases of influenza caused by strains similar to those contained in the vaccine compared to Fluzone, Sanofi said.