A pragmatic individually randomized trial to evaluate the effectiveness of high-dose vs standard-dose influenza vaccine in older adults: Rationale and design of the DANFLU-2 trial
Study context
- Population
- Older adults ≥65 years in Denmarkenrolled, enrollment completed in October 2024
- Participants
- 332,438 adults
- Planned comparison
- High-dose inactivated influenza vaccine (HD-IIV) vs standard-dose inactivated influenza vaccine (SD-IIV)
- Primary endpoint
- Hospitalization for influenza or pneumonia
Methodological detailsongoing, conducted in Denmark during the 2022/2023, 2023/2024, and 2024/2025 influenza seasons, electronic recruitment strategies and an online informed consent process, 1:1 randomization, data primarily obtained from the nationwide Danish administrative health registries, rationale and design report
- Ongoing
- Conducted in Denmark during the 2022/2023, 2023/2024, and 2024/2025 influenza seasons
- Electronic recruitment strategies and an online informed consent process
- 1:1 randomization
- Data primarily obtained from the nationwide Danish administrative health registries
- Rationale and design report
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 the effectiveness of high-dose vs standard-dose influenza vaccine in older adults: Rationale and design of the DANFLU-2 trial. Am Heart J. Published 30 July 2025. doi:10.
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