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NCT Number: NCT06684743

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

RSV Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • There are no specific exclusion criteria for this study

Treatment and study plan

RSV prefusion F protein-based vaccine

Biological

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

Other names: RSVpreF vaccine

Primary outcomes

  1. Hospitalization for RSV-related respiratory tract disease

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

Secondary outcomes

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

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

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

  2. RSV-related respiratory tract disease hospitalization

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

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

  3. Hospitalization for RSV-related lower respiratory tract disease

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

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

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

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

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

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

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

  6. RSV-related hospitalization

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

  7. All-cause respiratory tract disease hospitalization

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

  8. RSV-related cardio-respiratory hospitalization

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

  9. All-cause cardio-respiratory hospitalization

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

  10. All-cause lower respiratory tract disease hospitalization

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

  11. All-cause hospitalization

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

  12. All-cause mortality

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

Other outcomes

  1. Hospitalization for RSV-related respiratory tract disease stratified by RSV type

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

    Stratification by RSV type (A or B)

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

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

  3. RSV or pneumonia hospitalization [composite endpoint]

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

    Based only on ICD-10 codes

  4. Pneumonia hospitalization

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

  5. Any hospitalization with RSV infection

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

  6. Cardiovascular disease hospitalization

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

  7. Hospitalization requiring mechanical ventilation

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

  8. Intensive care unit hospitalization

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

  9. Myocardial infarction hospitalization

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

  10. Heart failure hospitalization

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

  11. Stroke hospitalization

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

  12. Influenza hospitalization

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

  13. COVID-19 hospitalization

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

  14. Hospitalization for pneumococcal disease

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

  15. Any infectious disease hospitalization

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

  16. MACE (composite endpoint)

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

    Non-fatal myocardial infarction, heart failure hospitalization, stroke, and cardiovascular death

  17. Laboratory-confirmed RSV infection

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

  18. Laboratory-confirmed influenza infection

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

  19. Laboratory-confirmed pneumococcal infection

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

  20. Laboratory-confirmed COVID-19 infection

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

  21. Cardio-respiratory mortality

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

  22. Respiratory mortality

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

  23. Cardiovascular mortality

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

  24. In-hospital mortality

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

  25. 30-day mortality following hospital discharge for primary endpoint

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

  26. Hospitalization for RSV-related lower respiratory tract disease in subsequent 2025/2026 and 2026/2027 RSV seasons

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

  27. RSV-related respiratory tract disease hospitalization by chronic obstructive pulmonary disease status

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

    Primary endpoint in patients with chronic obstructive pulmonary disease

  28. New-onset dementia

    Time frame: ≥14 days after initially booked vaccination/ information visit date up to 10 years

  29. RSV-related respiratory tract disease hospitalization by immunocompromised status

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

    Stratified by immunocompromised status. Analysis will be carried out as outlined in C3761080, EU PASS register number EUPAS1000000480

  30. RSV-related lower respiratory tract disease hospitalization by immunocompromised status

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

    Stratified by immunocompromised status. Analysis will be carried out as outlined in C3761080, EU PASS register number EUPAS1000000480

  31. All-cause respiratory tract disease hospitalization by immunocompromised status

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

    Stratified by immunocompromised status. Analysis will be carried out as outlined in C3761080, EU PASS register number EUPAS1000000480

  32. All-cause lower respiratory tract disease hospitalization by immunocompromised status

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

    Stratified by immunocompromised status. Analysis will be carried out as outlined in C3761080, EU PASS register number EUPAS1000000480

  33. RSV-related respiratory tract disease hospitalization by severe immunocompromised status

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

    Stratified by severe immunocompromised status. Analysis will be carried out as outlined in C3761080, EU PASS register number EUPAS1000000480

  34. All-cause respiratory tract disease hospitalization by severe immunocompromised status

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

    Stratified by severe immunocompromised status. Analysis will be carried out as outlined in C3761080, EU PASS register number EUPAS1000000480

  35. Atrial fibrillation hospitalization

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

    Analysis will be carried out as outlined in C3761080, EU PASS register number EUPAS1000000480

  36. Hospitalization for any cardiac arrythmia

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

    Analysis will be carried out as outlined in C3761080, EU PASS register number EUPAS1000000480

  37. Hospitalization for pericarditis

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

    Analysis will be carried out as outlined in C3761080, EU PASS register number EUPAS1000000480

  38. Hospitalization for myocarditis

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

    Analysis will be carried out as outlined in C3761080, EU PASS register number EUPAS1000000480

  39. Asthma exacerbation hospitalization

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

    Analysis will be carried out as outlined in C3761080, EU PASS register number EUPAS1000000480

  40. RSV-related respiratory tract disease hospitalization by hepatic or renal impairment status

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

    Among those with hepatic or renal impairment at baseline. Analysis will be carried out as outlined in C3761080, EU PASS register number EUPAS1000000480

  41. RSV-related MACE

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

  42. Laboratory-confirmed mycoplasma infection

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

  43. Laboratory-confirmed HMPV infection

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

  44. RSV-related tract disease hospitalization/emergency department visit

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

  45. Critical lower respiratory tract disease hospitalization

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

  46. Critical respiratory tract disease hospitalization

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

  47. RSV-related COPD exacerbation

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

  48. All-cause COPD exacerbation

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

  49. Asthma exacerbation

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

  50. RSV-related asthma exacerbation

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

Sponsors and collaborators

Lead sponsor

Tor Biering-Sørensen

Other

Collaborators

  • Pfizer

Registry information

Official study title

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

Acronym: DAN-RSV

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Nov 12, 2024
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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