Sanofi Pasteur announced positive results from an analysis of a large-scale, multicenter efficacy trial that evaluated patients who received a higher-dose split-virus inactivated influenza vaccine (IIV-HD; Fluzone High-Dose) vs. a standard-dose split-virus inactivated influenza vaccine (IIV-SD; Fluzone). Findings from the analysis are published in Vaccine.
In the study (n=31,989), adults aged ≥65 were randomized to IIV-HD or IIV-SD and followed for 6–8 months post-vaccination for the occurrence of influenza and serious events, including events leading to death or hospitalization, or life-threatening or medically important, or resulting in disability. Cardio-respiratory events into the following seven categories for the analysis: pneumonia, asthma, chronic obstructive pulmonary disease (COPD) or bronchial events, influenza (laboratory-confirmed influenza diagnosed outside of normal study procedures), other respiratory events, coronary artery events, congestive heart failure, and cerebrovascular events.
Results from the supplementary analysis showed that the rate of serious cardio-respiratory events possibly related to influenza was lower in the IIV-HD group vs. the IIV-SD group (17.7% vs. 32.5%). Also, serious pneumonia occurred 39.8% less among the IIV-HD group vs. the IIV-SD group. Rate of any cause hospitalization was also 6.9% less in the IIV-HD group vs. the IIV-SD group.
Fluzone High-Dose vaccine is indicated for active immunization for the prevention of influenza in patients aged ≥65.
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