A Pragmatic Randomized Trial to Evaluate the Vaccine Effectiveness of Abrysvo® for Preventing RSV Hospitalizations in Adults Aged 18 Years or Above (DAN-RSV)

Conditions

RSV-infection

Brief summary

Hospitalization for RSV-related respiratory tract disease

Detailed description

Hospitalization for RSV-related respiratory tract disease evaluated among the as-treated study population with balanced follow up time between study arms (key secondary), RSV-related lower respiratory tract disease hospitalization (key secondary), Stratifications of the primary endpoint by a. Age group (60-74 and 75+) b. Subsequent seasons (2025/2026 and 2026/2027 RSV seasons), RSV-related hospitalization, All-cause respiratory tract disease hospitalization (key secondary), RSV-related cardio-respiratory hospitalizations, All-cause cardio-respiratory hospitalizations, All-cause lower respiratory tract disease hospitalization, All-cause hospitalization, All-cause death

Mats Christian Højbjerg Lassen, Niklas Dyrby Johansen, Sarah Louise Christensen, Negar Aliabadi, Kristoffer Grundtvig Skaarup et al. (35 authors)

New England Journal of Medicine2025-08-309 citations

10.1056/nejmoa2509810

Interventions

DRUGAbrysvo powder and solvent for solution for injection Respiratory syncytial virus vaccine (bivalent

DRUGrecombinant)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Hospitalization for RSV-related respiratory tract disease	—

Secondary

Measure	Time frame
Hospitalization for RSV-related respiratory tract disease evaluated among the as-treated study population with balanced follow up time between study arms (key secondary), RSV-related lower respiratory tract disease hospitalization (key secondary), Stratifications of the primary endpoint by a. Age group (60-74 and 75+) b. Subsequent seasons (2025/2026 and 2026/2027 RSV seasons), RSV-related hospitalization, All-cause respiratory tract disease hospitalization (key secondary), RSV-related cardio-respiratory hospitalizations, All-cause cardio-respiratory hospitalizations, All-cause lower respiratory tract disease hospitalization, All-cause hospitalization, All-cause death	—

Measure

Time frame

Hospitalization for RSV-related respiratory tract disease evaluated among the as-treated study population with balanced follow up time between study arms (key secondary), RSV-related lower respiratory tract disease hospitalization (key secondary), Stratifications of the primary endpoint by a. Age group (60-74 and 75+) b. Subsequent seasons (2025/2026 and 2026/2027 RSV seasons), RSV-related hospitalization, All-cause respiratory tract disease hospitalization (key secondary), RSV-related cardio-respiratory hospitalizations, All-cause cardio-respiratory hospitalizations, All-cause lower respiratory tract disease hospitalization, All-cause hospitalization, All-cause death

—

Countries

Denmark, Spain

Outcome results

None listed