The purpose of this pragmatic randomized trial is to evaluate the vaccine effectiveness of bivalent RSV prefusion F vaccine (RSV vaccine) in adults. Participants will be randomized 1:1 to either RSV vaccine or no RSV vaccine.
The study is a pragmatic, registry-based, open-label, individually randomized trial. Administrative health registries will be used for data collection including baseline information, follow-up data, and safety monitoring. The study aims to randomize a total of 690,000 participants. Participants will be individually randomized 1:1 to receive either a bivalent RSV prefusion F vaccine (RSV vaccine) or no RSV vaccine. The trial is designed to assess the vaccine effectiveness of the RSV vaccine vs. no RSV vaccine on RSV-related and all-cause cardio-respiratory outcomes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
690,000
For this arm, the RSV prefusion F protein-based vaccine Abrysvo® will be used
Center for Translational Cardiology and Pragmatic Randomized Trials Department of Cardiology Copenhagen University Hospital - Herlev and Gentofte
Copenhagen, Denmark
Danske Lægers Vaccinations Service
Søborg, Denmark
General Public Health Directorate of Galician Health Service
Santiago de Compostela, A Coruña, Spain
Hospitalization for RSV-related respiratory tract disease
Time frame: ≥14 days after initially booked vaccination/ information visit date up to 8 months
RSV-related respiratory tract disease hospitalization (as-treated)
Among the as-treated study population with balanced follow up time between study arms
Time frame: ≥14 days after initially booked vaccination/ information visit date up to 8 months
RSV-related respiratory tract disease hospitalization
Primary outcome evaluated among the as-treated study population with balanced follow up time between study arms
Time frame: ≥14 days after actual vaccination date/ booked information visit date up to 8 months
Hospitalization for RSV-related lower respiratory tract disease
Time frame: ≥14 days after initially booked vaccination/ information visit date up to 8 months
Hospitalization for RSV-related respiratory tract disease by age groups
Stratified by age groups (18-59, 60-74 years and 75+ years)
Time frame: ≥14 days after initially booked vaccination/ information visit date up to 8 months
Hospitalization for RSV-related respiratory tract disease in subsequent seasons
Subsequent seasons (2025/2026 and 2026/2027 RSV seasons)
Time frame: From June 1, 2025 up to 12 months (2025/2026 season) and June 1, 2026 up to 12 months (2026/2027 season)
RSV-related hospitalization
Time frame: ≥14 days after initially booked vaccination/ information visit date up to 8 months
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All-cause respiratory tract disease hospitalization
Time frame: ≥14 days after initially booked vaccination/ information visit date up to 8 months
RSV-related cardio-respiratory hospitalization
Time frame: ≥14 days after initially booked vaccination/ information visit date up to 8 months
All-cause cardio-respiratory hospitalization
Time frame: ≥14 days after initially booked vaccination/ information visit date up to 8 months
All-cause lower respiratory tract disease hospitalization
Time frame: ≥14 days after initially booked vaccination/ information visit date up to 8 months
All-cause hospitalization
Time frame: ≥14 days after initially booked vaccination/ information visit date up to 8 months
All-cause mortality
Time frame: ≥14 days after initially booked vaccination/ information visit date up to 8 months