NCT06684743

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
690,000

participants targeted

Target at P75+ for phase_4

Timeline
27mo left

Started Nov 2024

Longer than P75 for phase_4

Geographic Reach
2 countries

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress40%
Nov 2024Aug 2028

First Submitted

Initial submission to the registry

November 8, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 12, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

November 18, 2024

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2028

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

November 25, 2025

Status Verified

October 1, 2025

Enrollment Period

3.5 years

First QC Date

November 8, 2024

Last Update Submit

November 20, 2025

Conditions

RSV

Keywords

RSVVaccinationPragmaticRegistryLower respiratory tract diseaseRespiratory tract diseaseRespiratoryCardiovascular

Outcome Measures

Primary Outcomes (1)

  • Hospitalization for RSV-related respiratory tract disease

    ≥14 days after initially booked vaccination/ information visit date up to 8 months

Secondary Outcomes (11)

  • RSV-related respiratory tract disease hospitalization

    ≥14 days after actual vaccination date/ booked information visit date up to 8 months

  • Hospitalization for RSV-related lower respiratory tract disease

    ≥14 days after initially booked vaccination/ information visit date up to 8 months

  • Hospitalization for RSV-related respiratory tract disease by age groups

    ≥14 days after initially booked vaccination/ information visit date up to 8 months

  • Hospitalization for RSV-related respiratory tract disease in subsequent seasons

    From September 1, 2025 up to 9 months (2025/2026 season) and September 1, 2026 up to 9 months (2026/2027 season)

  • RSV-related hospitalization

    ≥14 days after initially booked vaccination/ information visit date up to 8 months

  • +6 more secondary outcomes

Other Outcomes (40)

  • Hospitalization for RSV-related respiratory tract disease stratified by RSV type

    ≥14 days after initially booked vaccination/ information visit date up to 8 months

  • Total length of hospital stays due to respiratory tract infection with RSV infection

    ≥14 days after initially booked vaccination/ information visit date up to 8 months

  • RSV or pneumonia hospitalization [composite endpoint]

    ≥14 days after initially booked vaccination/ information visit date up to 8 months

  • +37 more other outcomes

Study Arms (2)

RSV prefusion F protein-based vaccine (RSV vaccine)

EXPERIMENTAL

RSV vaccine single injection at day 0

Biological: RSV prefusion F protein-based vaccine

No RSV vaccine (control)

NO INTERVENTION

Control arm, no RSV vaccine

Interventions

RSV prefusion F protein-based vaccineBIOLOGICAL

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

Also known as: RSVpreF vaccine
RSV prefusion F protein-based vaccine (RSV vaccine)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

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

Copenhagen, 2900, Denmark

NOT YET RECRUITING

Danske Lægers Vaccinations Service

Søborg, 2860, Denmark

RECRUITING

General Public Health Directorate of Galician Health Service

Santiago de Compostela, A Coruña, Spain

RECRUITING

Related Publications (3)

  • 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.

    PMID: 40888695DERIVED

  • 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.

    PMID: 40884493DERIVED

  • 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.

    PMID: 40738309DERIVED

MeSH Terms

Conditions

Respiratory Tract Diseases

Study Officials

  • 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 CHAIR

Central Study Contacts

Mats H Lassen, MD

CONTACT

+4529806779mats.christian.hoejbjerg.lassen@regionh.dk

Tor Biering-Sørensen, MD, PhD, MSc, MPH

CONTACT

+4528933590tor.biering-soerensen@regionh.dk

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 8, 2024

First Posted

November 12, 2024

Study Start

November 18, 2024

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

August 1, 2028

Last Updated

November 25, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will share

In this trial, baseline and endpoint data will be collected from Danish administrative health registries, which are subject to Danish legislation and can only be made available to a third party under certain conditions. Please contact the sponsor-investigator in case of any inquiries.

Shared Documents
STUDY PROTOCOL, SAP

Locations

ES(1)DK(2)