DAN-RSV
A Pragmatic Randomized Trial to Evaluate the Vaccine Effectiveness of Bivalent RSV Prefusion F Vaccine (Abrysvo) for Preventing RSV Hospitalizations in Adults
Patient / Population Intervention / Exposure Comparison Outcome
In about 690,000 adults across two RSV seasons in Denmark and Galicia, a single dose of RSVpreF vaccine was compared with no vaccine on hospitalisation for RSV-related respiratory disease.
N
690,000
Design
Pragmatic, registry-based, open-label, individually randomised trial, 1:1 RSVpreF vs no RSV vaccine; recruitment by nationwide electronic invitation with remote e-consent, baseline and outcome data from national health registries; outcomes counted from 14 days after vaccination through the RSV season (up to 8 months), with subsequent-season outcomes prespecified
Endpoint
Hospitalisation for RSV-related respiratory tract disease