A pragmatic individually randomized trial to evaluate bivalent respiratory syncytial virus (RSV) prefusion F protein–based vaccine effectiveness for preventing RSV hospitalizations in adults aged 60 years or above (DAN-RSV): Rationale and trial design
Study context
- Population
- Danish adults aged 60 and olderplanned enrolment during the 2024/2025 winter season
- Participants
- Up to 130,000 adults
- Planned comparison
- RSVpreF vs no RSV vaccine
- Primary endpoint
- vaccine effectiveness (VE) against RSV-related respiratory tract disease hospitalization
Methodological detailsnationwide registries for recruitment, electronic informed consent, data collected through national health registries, 1:1 randomization
- Nationwide registries for recruitment
- Electronic informed consent
- Data collected through national health registries
- 1:1 randomization
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
A pragmatic individually randomized trial to evaluate bivalent RSV prefusion F protein–based vaccine effectiveness for preventing RSV hospitalizations in adults aged 60 years or above (DAN-RSV): Rationale and trial design. Am Heart J. Published 28 July 2025. doi:10.
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