NCT06684743

Vaccine Effectiveness of a Bivalent RSV Prefusion F Protein-Based Vaccine for Preventing RSV Hospitalizations in Adults

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 690,000 (estimated)
• Sponsor: Tor Biering-Sørensen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• RSV

Interventions

Type	Name	Description
BIOLOGICAL	RSV prefusion F protein-based vaccine	For this arm, the RSV prefusion F protein-based vaccine Abrysvo® will be used

Timeline

• Start date: 2024-11-18
• Primary completion: 2028-05-01
• Completion: 2028-08-01
• First posted: 2024-11-12
• Last updated: 2025-11-25

Locations

3 sites across 2 countries: Denmark, Spain