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RECRUITING
NCT06684743
PHASE4

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

Sponsor: Tor Biering-Sørensen

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

690000

Start Date

2024-11-18

Completion Date

2028-08

Last Updated

2025-11-25

Healthy Volunteers

Yes

Conditions

Interventions

BIOLOGICAL

RSV prefusion F protein-based vaccine

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

Locations (3)

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