Vaccine Effectiveness of a Bivalent RSV Prefusion F Protein-Based Vaccine for Preventing RSV Hospitalizations in Adults
NCT ID: NCT06684743
Last Updated: 2025-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
690000 participants
INTERVENTIONAL
2024-11-18
2028-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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RSV prefusion F protein-based vaccine (RSV vaccine)
RSV vaccine single injection at day 0
RSV prefusion F protein-based vaccine
For this arm, the RSV prefusion F protein-based vaccine Abrysvo® will be used
No RSV vaccine (control)
Control arm, no RSV vaccine
No interventions assigned to this group
Interventions
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RSV prefusion F protein-based vaccine
For this arm, the RSV prefusion F protein-based vaccine Abrysvo® will be used
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Informed consent form has been signed and dated
18 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Tor Biering-Sørensen
OTHER
Responsible Party
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Tor Biering-Sørensen
Professor
Principal Investigators
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Tor Biering-Sørensen, MD, PhD, MSc, MPH
Role: STUDY_CHAIR
Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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References
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Lassen MCH, Johansen ND, Christensen SH, Aliabadi N, Skaarup KG, Modin D, Claggett BL, Larsen CS, Larsen L, Wiese L, Dalager-Pedersen M, Lindholm MG, Jensen AMR, Dons M, Bernholm KF, Davidovski FS, Duus LS, Ottosen CI, Nielsen AB, Borchsenius JH, Espersen C, Kose G, Fussing FH, Kober L, Solomon SD, Jensen JUS, Martel CJ, Gessner BD, Schwarz C, Gonzalez E, Skovdal M, Moulton LH, Zhang P, Begier E, Biering-Sorensen T. RSV Prefusion F Vaccine for Prevention of Hospitalization in Older Adults. N Engl J Med. 2025 Aug 30. doi: 10.1056/NEJMoa2509810. Online ahead of print.
Lassen MCH, Johansen ND, Christensen SH, Aliabadi N, Skaarup KG, Modin D, Claggett BL, Larsen CS, Larsen L, Wiese L, Dalager-Pedersen M, Lindholm MG, Jensen AMR, Dons M, Bernholm KF, Davidovski FS, Duus LS, Ottosen CI, Nielsen AB, Borchsenius JH, Espersen C, Kose G, Fussing FH, Pareek M, Kober L, Solomon SD, Jensen JUS, Martel CJ, Gessner BD, Schwarz C, Gonzalez E, Skovdal M, Moulton LH, Zhang P, Begier E, Biering-Sorensen T. Bivalent RSV Prefusion F Protein-Based Vaccine for Preventing Cardiovascular Hospitalizations in Older Adults: A Prespecified Analysis of the DAN-RSV Trial. JAMA. 2025 Oct 28;334(16):1431-1441. doi: 10.1001/jama.2025.15405.
Lassen MCH, Christensen SH, Johansen ND, Aliabadi N, Skaarup KG, Modin D, Claggett BL, Larsen CS, Larsen L, Wiese L, Dalager-Pedersen M, Lindholm MG, Kober L, Solomon SD, Staehr Jensen JU, Martel CJ, Schwarz C, Gonzalez E, Skovdal M, Moulton LH, Zhang P, Gessner BD, Begier E, Biering-Sorensen T. A pragmatic individually randomized trial to evaluate bivalent RSV prefusion F protein-based vaccine effectiveness for preventing RSV hospitalizations in adults aged 60 years or above (DAN-RSV): Rationale and trial design. Am Heart J. 2026 Jan;291:14-25. doi: 10.1016/j.ahj.2025.07.068. Epub 2025 Jul 28.
Other Identifiers
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2024-516600-42-00
Identifier Type: CTIS
Identifier Source: secondary_id
DAN-RSV
Identifier Type: -
Identifier Source: org_study_id
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