A Pragmatic Randomized Trial to Evaluate the Vaccine Effectiveness of Abrysvo® for Preventing RSV Hospitalizations in Adults Aged 18 Years or Above
Overview
- Phase
- Phase 4
- Intervention
- RSV prefusion F protein-based vaccine
- Conditions
- RSV
- Sponsor
- Tor Biering-Sørensen
- Enrollment
- 690000
- Locations
- 3
- Primary Endpoint
- Hospitalization for RSV-related respiratory tract disease
- Status
- Recruiting
- Last Updated
- 5 months ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Tor Biering-Sørensen
Professor
Herlev and Gentofte Hospital
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •There are no specific exclusion criteria for this study
Arms & Interventions
RSV prefusion F protein-based vaccine (RSV vaccine)
RSV vaccine single injection at day 0
Intervention: RSV prefusion F protein-based vaccine
Outcomes
Primary Outcomes
Hospitalization for RSV-related respiratory tract disease
Time Frame: ≥14 days after initially booked vaccination/ information visit date up to 8 months
Secondary Outcomes
- RSV-related respiratory tract disease hospitalization(≥14 days after actual vaccination date/ booked information visit date up to 8 months)
- Hospitalization for RSV-related lower respiratory tract disease(≥14 days after initially booked vaccination/ information visit date up to 8 months)
- Hospitalization for RSV-related respiratory tract disease by age groups(≥14 days after initially booked vaccination/ information visit date up to 8 months)
- Hospitalization for RSV-related respiratory tract disease in subsequent seasons(From September 1, 2025 up to 9 months (2025/2026 season) and September 1, 2026 up to 9 months (2026/2027 season))
- RSV-related hospitalization(≥14 days after initially booked vaccination/ information visit date up to 8 months)
- All-cause respiratory tract disease hospitalization(≥14 days after initially booked vaccination/ information visit date up to 8 months)
- RSV-related cardio-respiratory hospitalization(≥14 days after initially booked vaccination/ information visit date up to 8 months)
- All-cause cardio-respiratory hospitalization(≥14 days after initially booked vaccination/ information visit date up to 8 months)
- All-cause lower respiratory tract disease hospitalization(≥14 days after initially booked vaccination/ information visit date up to 8 months)
- All-cause hospitalization(≥14 days after initially booked vaccination/ information visit date up to 8 months)
- All-cause mortality(≥14 days after initially booked vaccination/ information visit date up to 8 months)