RecruitingPhase 4NCT06684743

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


Sponsor

Tor Biering-Sørensen

Enrollment

690,000 participants

Start Date

Nov 18, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria2

  • Age 18 years and above
  • Informed consent form has been signed and dated

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Interventions

BIOLOGICALRSV 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

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NCT06684743


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