SWIFTWATER, Pa. — Sanofi Pasteur, the vaccines division of Sanofi, released data from a new study examining the ability of its Fluzone High-Dose vaccine to provoke an immune response in elderly and younger adults, compared with a standard dose of Fluzone vaccine.
"The results further support the immunogenicity advantages of Fluzone High-Dose vaccine as compared to Fluzone vaccine, the standard dose comparator, in seniors 65 years of age and older," stated Peter Tsang, director clinical development, Sanofi Pasteur.
Fluzone High-Dose vaccine was licensed by the Food and Drug Administration in December 2009 for adults ages 65 years and older because the vaccine addressed an unmet medical need. People older than 65 years of age have the highest rates of hospitalization and death from influenza and its complications, despite having among the highest immunization rates against influenza. The immune response of people ages 65 years and older to the traditional flu shot is substantially lower than that of younger people. Thus, Fluzone High-Dose vaccine was developed to generate a more robust immune response in the senior population.
In the multicenter trial, 639 subjects between the ages of 65 and 96 were randomized to receive one standard dose of Fluzone vaccine or Fluzone High-Dose vaccine and 186 younger adults ages 18 through 49 years received Fluzone vaccine. Both influenza vaccines were formulated with the influenza virus strains for the 2007-2008 season and contained A/Solomon (H1N1), A/Wisconsin (H3N2) and B/Malaysia.
Hemagglutination Immunization antibody titers were measured before and 28 days post-vaccination.
Among those ages 65 years and older, statistically significantly higher antibody responses were induced by Fluzone High-Dose vaccine compared to Fluzone vaccine. Administration of Fluzone High-Dose vaccine in people over the age of 65 years enhanced the antibody response to levels similar to, and for some parameters higher than, those observed in younger adults receiving the standard dose of Fluzone vaccine.
The data were presented at the 49th Annual Meeting of the Infectious Diseases Society of America.