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

Study acronym: DAN-RSV
StatusActive, Not Recruiting
PhasePhase 4
Started
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Record History

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  1. Trial status: Recruiting to Active, Not Recruiting
    • Secondary endpoints: 11 to 12
    • Site details revised at 3 of 3 sites
    v5
  2. Trial status: Active, Not Recruiting to Recruitingv4 Show 8 more changesShow less
    • Enrollment target: 130000 to 690000
    • Primary completion date: May 2027 to May 2028
    • Study sites: 2 to 3
    • Study completion date: Aug 2027 to Aug 2028
    • Eligibility criteria revised
    • Secondary endpoints: details revised at 1 of 11 entries
    • Study description revised
    • Study title shortened, about 1 word
  3. Trial status: Recruiting to Active, Not Recruiting
    • Secondary endpoints: 10 to 11
    • Site details revised at 2 of 2 sites
    v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 2024 to Nov 18, 2024
    • Site details revised at 2 of 2 sites
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06684743
Lead Sponsor Tor Biering-Sørensen
Collaborators: Pfizer
Conditions
(from sponsor)		 RSV
Related terms Respiratory Tract Diseases
Enrollment 690,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov