Three studies of Fluad (MF59-adjuvanted seasonal trivalent vaccine) reinforce safety and immunogenicity profiles in influenza prevention- Seqirus

Seqirus has announced results from three analyses of a total of 42 clinical trials that evaluated the safety and immunogenicity of Fluad (MF59-adjuvanted seasonal trivalent influenza vaccine) in adults 65 years of age and older. The first integrated analysis of safety data from 36 clinical trials assessed the risk of less common but serious adverse events with MF59-adjuvanted seasonal trivalent influenza vaccine in adults aged 65 years and older compared to non-adjuvanted trivalent influenza vaccines. Results showed vaccination with MF59-adjuvanted seasonal trivalent influenza vaccine resulted in an increase in mild to moderate solicited adverse events (AEs) as compared to non-adjuvanted trivalent vaccines, but no increased risk of unsolicited AEs, including serious AE or deaths. Results also suggested that revaccination with MF59-adjuvanted seasonal trivalent influenza vaccine in subsequent influenza seasons was well tolerated in older adults 65 and older.

In a second analysis of data from four clinical trials, the immunogenicity of MF59-adjuvanted seasonal trivalent influenza vaccine against heterologous seasonal influenza virus strains was evaluated among adults aged 65 years and older immunized with either MF59-adjuvanted seasonal trivalent influenza vaccine or a non-adjuvanted trivalent vaccine comparator. The MF59-adjuvanted seasonal trivalent influenza vaccine demonstrated increased breadth of antibody responses in comparison to non-adjuvanted comparators.

The third analysis, using samples of two seasonal licensure Phase II trials in adults aged 61 years and older, evaluated the heterologous antibody response against the antigenically drifted H3N2 strain during the 2014-2015 season in individuals vaccinated with either MF59-adjuvanted seasonal trivalent influenza or non-adjuvanted trivalent vaccine comparator. The data from the clinical trials and post licensure studies suggest that MF59-adjuvanted seasonal trivalent influenza vaccine generated a higher percentage of significant antibody titer increase against both vaccine strain-specific and heterologous influenza virus strains. The analyses, which add to the body of evidence of benefit in using adjuvanted influenza vaccines among elderly patient populations were presented at the Options IX for the Control of Influenza conference (Options IX).