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

NCT06684743 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 690000

Last updated 2025-11-25

No results posted yet for this 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.

Conditions

Interventions

BIOLOGICAL

RSV prefusion F protein-based vaccine

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

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Tor Biering-Sørensen

    lead OTHER

Principal Investigators

  • Tor Biering-Sørensen, MD, PhD, MSc, MPH · Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-18
Primary Completion
2028-05-31
Completion
2028-08-31

Countries

  • Denmark
  • Spain

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06684743 on ClinicalTrials.gov