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RSVPhase 4DAN-RSVNCT06684743

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

A Phase 4 study testing RSV prefusion F protein-based vaccine in people with RSV, run by Tor Biering-Sørensen at 3 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
RSV
What is being tested?
RSV prefusion F protein-based vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
690,000 participants
Where
3 sitesin 2 countries
Study dates
18 Nov 2024to Aug 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • There are no specific exclusion criteria for this study

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

Denmark2 sites

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

    Copenhagen, 2900

  • Danske Lægers Vaccinations Service

    Søborg, 2860

Other trials in Denmark

Spain1 site

  • General Public Health Directorate of Galician Health Service

    Santiago de Compostela, A Coruña

Other trials in Spain

About this study

Official title: A Pragmatic Randomized Trial to Evaluate the Vaccine Effectiveness of Abrysvo® for Preventing RSV Hospitalizations in Adults Aged 18 Years or Above

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.

Read the detailed description

The study is a pragmatic, registry-based, open-label, individually randomized trial. Administrative health registries will be used for data collection including baseline information, follow-up data, and safety monitoring. The study aims to randomize a total of 690,000 participants. Participants will be individually randomized 1:1 to receive either a bivalent RSV prefusion F vaccine (RSV vaccine) or no RSV vaccine. The trial is designed to assess the vaccine effectiveness of the RSV vaccine vs. no RSV vaccine on RSV-related and all-cause cardio-respiratory outcomes.

Conditions
RSV
Being tested
RSV prefusion F protein-based vaccine
Keywords
RSV, Vaccination, Pragmatic, Registry, Lower respiratory tract disease, Respiratory tract disease, Respiratory, Cardiovascular
Medical subject headings
Respiratory Tract Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RSV prefusion F protein-based vaccineBiological

    Also called RSVpreF vaccine

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

Study groups in NCT06684743
Study groupRoleWhat they receive
RSV prefusion F protein-based vaccine (RSV vaccine)ExperimentalRSV vaccine single injection at day 0
Receives: Biological: RSV prefusion F protein-based vaccine
No RSV vaccine (control)No interventionControl arm, no RSV vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hospitalization for RSV-related respiratory tract disease

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

Secondary outcomes (12)

  1. RSV-related respiratory tract disease hospitalization (as-treated)

    Among the as-treated study population with balanced follow up time between study arms

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

  2. RSV-related respiratory tract disease hospitalization

    Primary outcome evaluated among the as-treated study population with balanced follow up time between study arms

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

  3. Hospitalization for RSV-related lower respiratory tract disease

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

  4. Hospitalization for RSV-related respiratory tract disease by age groups

    Stratified by age groups (18-59, 60-74 years and 75+ years)

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

  5. Hospitalization for RSV-related respiratory tract disease in subsequent seasons

    Subsequent seasons (2025/2026 and 2026/2027 RSV seasons)

    Measured: From June 1, 2025 up to 12 months (2025/2026 season) and June 1, 2026 up to 12 months (2026/2027 season)

  6. RSV-related hospitalization

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

  7. All-cause respiratory tract disease hospitalization

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

  8. RSV-related cardio-respiratory hospitalization

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

  9. All-cause cardio-respiratory hospitalization

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

  10. All-cause lower respiratory tract disease hospitalization

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

  11. All-cause hospitalization

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

  12. All-cause mortality

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Nov 2024
  2. Study start18 Nov 2024
  3. Primary completionMay 2028 (estimated)
  4. Study completionAug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
690,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06684743
Sponsor's protocol ID
DAN-RSV
Other IDs
2024-516600-42-00
Acronym
DAN-RSV
Status last verified
Oct 2025
First submitted
8 Nov 2024
Last updated
29 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Skaarup KG, Lassen MCH, Yafasov M, Pareek M, Christensen SH, Johansen ND, Rudolph AE, Rodriguez-Tenreiro-Sanchez C, 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, Lenz IT, Christensen J, Simonsen JO, Afzal M, Bartholdy KV, Langhoff ACF, Kober L, Solomon SD, Jensen JUS, Martel CJ, Gine-Vazquez I, Duran-Parrondo C, Pineiro-Sotelo M, Cribeiro-Gonzalez M, Conde-Pajaro M, Miras-Carballal S, Gonzalez-Perez JM, Gessner BD, Aliabadi N, Schwarz C, Skovdal M, Moulton LH, Zhang P, Lopez-Gomez V, Welsh S, Anatale-Tardiff L, Cane A, Hayford K, Martinon-Torres F, Begier E, Biering-Sorensen T. RSV vaccine for preventing respiratory and cardiovascular hospitalizations in heart failure: a prespecified analysis of the extended DAN-RSV trial. Eur J Heart Fail. 2026 Sep 7:xuag282. doi: 10.1093/ejhf/xuag282. Online ahead of print.

    PubMed 42702887

  • Lassen MC, Christensen SH, Yafasov M, Pareek M, Johansen ND, Rudolph AE, R-T Sanchez C, 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, Lenz IT, Christensen J, Simonsen JO, Afzal M, Bartholdy KV, Langhoff ACF, Kober L, Solomon SD, Jensen JUS, Martel CJ, Gine-Vazquez I, Duran-Parrondo C, Pineiro-Sotelo M, Cribeiro-Gonzalez M, Conde-Pajaro M, Miras-Carballal S, Gonzalez-Perez JM, Gessner BD, Aliabadi N, Schwarz C, Skovdal M, Moulton LH, Zhang P, Lopez-Gomez V, Welsh S, Anatale-Tardiff L, Cane A, Hayford K, Martinon-Torres F, Begier E, Biering-Sorensen T. Bivalent RSV Prefusion F Vaccine to Prevent Hospitalizations in Adults. NEJM Evid. 2026 Aug 29:EVIDoa2600272. doi: 10.1056/EVIDoa2600272. Online ahead of print.

    PubMed 42666095

  • Hojbjerg Lassen MC, Johansen ND, Christensen SH, Rudolph AE, 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, Yafasov M, Pareek M, Kober L, Solomon SD, Jensen JUS, Martel CJ, Aliabadi N, Gessner BD, Schwarz C, Skovdal M, Zhang P, Welsh S, Begier E, Biering-Sorensen T. Durability of RSV Prefusion F Vaccine Protection across Two RSV Seasons. NEJM Evid. 2026 Aug 29:EVIDoa2600242. doi: 10.1056/EVIDoa2600242. Online ahead of print.

    PubMed 42666088

  • 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. 2026 Jan 8;394(2):138-151. doi: 10.1056/NEJMoa2509810. Epub 2025 Aug 30.

    PubMed 40888695

  • 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.

    PubMed 40884493

  • 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.

    PubMed 40738309

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing RSV prefusion F protein-based vaccine in people with RSV, run by Tor Biering-Sørensen at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Denmark, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hospitalization for RSV-related respiratory tract disease (time frame: ≥14 days after initially booked vaccination/ information visit date up to 8 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06684743, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.

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