Sanofi registers alirocumab cardiovascular outcomes study; RSV+HMPV vaccine trial recruiting

This week brings one newly posted Sanofi study alongside two carried-over items.

• Sanofi has registered a new observational study, "OPTIMUS-EPIC," using target trial emulation to estimate the effect of alirocumab versus no PCSK9 inhibitor on major cardiovascular events in individuals with established ASCVD and no prior ischemic events, using routine clinical practice data from the Netherlands.¹ The study enrolled 4006 participants (actual)¹ and its primary outcome is Composite of Nonfatal Myocardial Infarction, Nonfatal Ischemic Stroke, or All-Cause Mortality, tracked from index up to 5 years follow up.¹
• Sanofi's Phase 1/2 trial of a bivalent RSV+HMPV vaccine candidate in adults 60 and older is recruiting, with a start date of 2026-07-22. The study aims to evaluate the immunogenicity and safety of an RSV+HMPV vaccine candidate for the prevention of RSV and HMPV disease among adults 60 years of age and older² and plans to enroll approximately 2400 adults 60 years of age and older².
• Previously reported: the HealthPartners-led Tdap lactation study, on which Sanofi is a collaborator, remains completed. The retrospective cohort study assesses the association between antenatal and postpartum maternal Tdap vaccination and select infant and lactation-related outcomes³, with enrollment of 36245 participants (actual)³.