A pragmatic randomized trial to evaluate the vaccine effectiveness of bivalent respiratory syncytial virus (RSV) prefusion F vaccine for preventing RSV hospitalizations in adults (DAN-RSV): Trial design update
Study context
- Population
- Danish adults aged ≥60 years (2024/2025 season) and adults aged ≥18 years in Denmark and Galicia, Spain (2025/2026 season)Danish adults aged ≥60 years enrolled during the initial 2024/2025 season, planned sample size up to ≈690,000 participants across both seasons
- Participants
- 131,379 adults
- Planned comparison
- 1:1 to RSV prefusion F (RSVpreF) vaccine or no vaccine
- Primary endpoint
- RSV-related respiratory tract disease hospitalization
Methodological detailstrial design update, 1:1 randomization, intention-to-treat analyses, hierarchical testing
- Trial design update
- 1:1 randomization
- Intention-to-treat analyses
- Hierarchical testing
No results yet. This paper sets out the design of a trial; its results are to come.
Further findings
Conduct of the study
- Increase in the planned sample size to up to ≈690,000 participants across both seasons
- 690,000
- Following lower-than-expected event accrual and expansion of the EU indication to adults 18 years and older, the trial was extended to continue enrollment of adults aged ≥18 years across Denmark and Galicia, Spain during the 2025/2026 RSV season
Original publication
A pragmatic randomized trial to evaluate the vaccine effectiveness of bivalent RSV prefusion F vaccine for preventing RSV hospitalizations in adults (DAN-RSV): Trial design update. Am Heart J. Published 1 June 2026. doi:10.
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