High-dose vs. standard-dose inactivated influenza vaccine and cardiovascular outcomes in persons with or without pre-existing atherosclerotic cardiovascular disease: the DANFLU-2 trial
Authors' conclusion
Among individuals ≥65 years, the rVE of HD-IIV vs. SD-IIV against respiratory and cardiovascular outcomes was similar among those with vs. without pre-existing ASCVD.
Study context
- Population
- Adults ≥65 years in Denmark, with or without pre-existing atherosclerotic CVD (atherosclerotic cardiovascular disease (ASCVD)), over three influenza seasons
- Comparison
- High-dose vs standard-dose inactivated influenza vaccine, by pre-existing ASCVD
- Primary endpoint
- Hospitalization for influenza or pneumonia
Methodological detailsopen-label, individually randomized, Denmark, three influenza seasons, nationwide registries, Baseline and outcome data from nationwide registries
- Open-label
- Individually randomized
- Denmark
- Three influenza seasons
- Nationwide registries
- Baseline and outcome data from nationwide registries
Primary result
As reported in the abstract
Hospitalization for influenza or pneumonia: rVE of HD-IIV vs standard-dose inactivated influenza vaccination (SD-IIV), by pre-existing ASCVD
Further findings
rVE
Without ASCVD
42.88%(95% CI 22.07–58.44)
With ASCVD
45.73%(95% CI 16.68–65.16)
- Pinteraction = .84
rVE
Without ASCVD
4.29%(95% CI −6.50–14.00)
With ASCVD
0.30%(95% CI −17.56–15.44)
- Pinteraction = .68
Original publication
High-dose vs. standard-dose inactivated influenza vaccine and cardiovascular outcomes in persons with or without pre-existing atherosclerotic cardiovascular disease: the DANFLU-2 trial. Eur Heart J. Published 30 August 2025. doi:10.
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