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

Last updated: November 20, 2025
Sponsor: Tor Biering-Sørensen
Overall Status: Active - Recruiting

Phase

4

Condition

Respiratory Syncytial Virus (Rsv) Infection

Respiratory Syncytial Virus (Rsv)

Treatment

RSV prefusion F protein-based vaccine

Clinical Study ID

NCT06684743
DAN-RSV
2024-516600-42-00
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria

  • Age 18 years and above

  • Informed consent form has been signed and dated

Exclusion

Exclusion Criteria:

  • There are no specific exclusion criteria for this study

Study Design

Total Participants: 690000
Treatment Group(s): 1
Primary Treatment: RSV prefusion F protein-based vaccine
Phase: 4
Study Start date:
November 18, 2024
Estimated Completion Date:
August 31, 2028

Study 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.

Connect with a study center

  • Center for Translational Cardiology and Pragmatic Randomized Trials Department of Cardiology Copenhagen University Hospital - Herlev and Gentofte

    Copenhagen, 2900
    Denmark

    Site Not Available

  • Center for Translational Cardiology and Pragmatic Randomized Trials Department of Cardiology Copenhagen University Hospital - Herlev and Gentofte

    Copenhagen 2618425, 2900
    Denmark

    Site Not Available

  • Danske Lægers Vaccinations Service

    Søborg, 2860
    Denmark

    Site Not Available

  • Danske Lægers Vaccinations Service

    Søborg 2613204, 2860
    Denmark

    Active - Recruiting

  • General Public Health Directorate of Galician Health Service

    Santiago de Compostela 3109642, A Coruña
    Spain

    Active - Recruiting

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