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.

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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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