Vaccine Effectiveness of a Bivalent RSV Prefusion F Protein-Based Vaccine for Preventing RSV Hospitalizations in Older Adults
- Conditions
- RSV
- Interventions
- Biological: RSV prefusion F protein-based vaccine
- Registration Number
- NCT06684743
- Lead Sponsor
- Tor Biering-Sørensen
- Brief Summary
The purpose of this pragmatic randomized trial is to evaluate the vaccine effectiveness of bivalent RSV prefusion F vaccine (RSV vaccine) in older 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. The Danish nationwide administrative health registries will be used for data collection including baseline information, follow-up data, and safety monitoring. The study aims to randomize 130,000 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 130000
Not provided
- There are no specific exclusion criteria for this study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description RSV prefusion F protein-based vaccine (RSV vaccine) RSV prefusion F protein-based vaccine RSV vaccine single injection at day 0
- Primary Outcome Measures
Name Time Method Hospitalization for RSV-related respiratory tract disease ≥14 days after initially booked vaccination/ information visit date up to 8 months
- Secondary Outcome Measures
Name Time Method 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) Subsequent seasons (2025/2026 and 2026/2027 RSV seasons)
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 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 Hospitalization for RSV-related lower respiratory tract disease ≥14 days after initially booked vaccination/ information visit date up to 8 months RSV-related hospitalization ≥14 days after initially booked vaccination/ information visit date up to 8 months RSV-related respiratory tract disease hospitalization ≥14 days after actual vaccination date/ booked information visit date up to 8 months Primary outcome evaluated among the as-treated study population with balanced follow up time between study arms
All-cause lower respiratory tract disease hospitalization ≥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 Stratified by age groups (60-74 years and 75+ years)
All-cause respiratory tract disease hospitalization ≥14 days after initially booked vaccination/ information visit date up to 8 months
Trial Locations
- Locations (2)
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
Center for Translational Cardiology and Pragmatic Randomized Trials Department of Cardiology Copenhagen University Hospital - Herlev and Gentofte🇩🇰Copenhagen, Denmark