A Pragmatic Randomized Trial to Evaluate the Vaccine Effectiveness of Abrysvo® for Preventing RSV Hospitalizations in Adults Aged 18 Years or Above (DAN-RSV)

NCT06684743 Phase 4 RECRUITING

The purpose of this pragmatic randomized trial is to evaluate the vaccine effectiveness of bivalent RSV prefusion F vaccine (RSV vaccine) in adults. Participants will be randomized 1:1 to either RSV vaccine or no RSV vaccine.

Details

Lead sponsor	Tor Biering-Sørensen
Phase	Phase 4
Status	RECRUITING
Enrolment	690000
Start date	2024-11-18
Completion	2028-08

Conditions

• RSV

Interventions

• RSV prefusion F protein-based vaccine

Primary outcomes

• Hospitalization for RSV-related respiratory tract disease — ≥14 days after initially booked vaccination/ information visit date up to 8 months

Countries

Denmark, Spain