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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-516600-42-00 | EU Trial (CTIS) Number |
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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RSV prefusion F protein-based vaccine (RSV vaccine) | Experimental | RSV vaccine single injection at day 0 |
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| No RSV vaccine (control) | No Intervention | Control arm, no RSV vaccine |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RSV prefusion F protein-based vaccine | Biological | For this arm, the RSV prefusion F protein-based vaccine Abrysvo® will be used |
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| Measure | Description | Time Frame |
|---|---|---|
| Hospitalization for RSV-related respiratory tract disease | ≥14 days after initially booked vaccination/ information visit date up to 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| RSV-related respiratory tract disease hospitalization (as-treated) | Among the as-treated study population with balanced follow up time between study arms | ≥14 days after initially booked vaccination/ information visit date up to 8 months |
| RSV-related respiratory tract disease hospitalization |
| Measure | Description | Time Frame |
|---|---|---|
| Hospitalization for RSV-related respiratory tract disease stratified by RSV type | Stratification by RSV type (A or B) | ≥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 |
Inclusion Criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Translational Cardiology and Pragmatic Randomized Trials Department of Cardiology Copenhagen University Hospital - Herlev and Gentofte | Copenhagen | 2900 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40888695 | Derived | 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. | |
| 40884493 |
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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.
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| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
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Primary outcome evaluated among the as-treated study population with balanced follow up time between study arms |
| ≥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 | Stratified by age groups (18-59, 60-74 years and 75+ years) | ≥14 days after initially booked vaccination/ information visit date up to 8 months |
| Hospitalization for RSV-related respiratory tract disease in subsequent seasons | Subsequent seasons (2025/2026 and 2026/2027 RSV seasons) | From June 1, 2025 up to 12 months (2025/2026 season) and June 1, 2026 up to 12 months (2026/2027 season) |
| RSV-related hospitalization | ≥14 days after initially booked vaccination/ information visit date up to 8 months |
| All-cause respiratory tract disease hospitalization | ≥14 days after initially booked vaccination/ information visit date up to 8 months |
| RSV-related cardio-respiratory hospitalization | ≥14 days after initially booked vaccination/ information visit date up to 8 months |
| All-cause cardio-respiratory hospitalization | ≥14 days after initially booked vaccination/ information visit date up to 8 months |
| All-cause lower respiratory tract disease hospitalization | ≥14 days after initially booked vaccination/ information visit date up to 8 months |
| All-cause hospitalization | ≥14 days after initially booked vaccination/ information visit date up to 8 months |
| All-cause mortality | ≥14 days after initially booked vaccination/ information visit date up to 8 months |
| ≥14 days after initially booked vaccination/ information visit date up to 8 months |
| RSV or pneumonia hospitalization [composite endpoint] | Based only on ICD-10 codes | ≥14 days after initially booked vaccination/ information visit date up to 8 months |
| Pneumonia hospitalization | ≥14 days after initially booked vaccination/ information visit date up to 8 months |
| Any hospitalization with RSV infection | ≥14 days after initially booked vaccination/ information visit date up to 8 months |
| Cardiovascular disease hospitalization | ≥14 days after initially booked vaccination/ information visit date up to 8 months |
| Hospitalization requiring mechanical ventilation | ≥14 days after initially booked vaccination/ information visit date up to 8 months |
| Intensive care unit hospitalization | ≥14 days after initially booked vaccination/ information visit date up to 8 months |
| Myocardial infarction hospitalization | ≥14 days after initially booked vaccination/ information visit date up to 8 months |
| Heart failure hospitalization | ≥14 days after initially booked vaccination/ information visit date up to 8 months |
| Stroke hospitalization | ≥14 days after initially booked vaccination/ information visit date up to 8 months |
| Influenza hospitalization | ≥14 days after initially booked vaccination/ information visit date up to 8 months |
| COVID-19 hospitalization | ≥14 days after initially booked vaccination/ information visit date up to 8 months |
| Hospitalization for pneumococcal disease | ≥14 days after initially booked vaccination/ information visit date up to 8 months |
| Any infectious disease hospitalization | ≥14 days after initially booked vaccination/ information visit date up to 8 months |
| MACE (composite endpoint) | Non-fatal myocardial infarction, heart failure hospitalization, stroke, and cardiovascular death | ≥14 days after initially booked vaccination/ information visit date up to 8 months |
| Laboratory-confirmed RSV infection | ≥14 days after initially booked vaccination/ information visit date up to 8 months |
| Laboratory-confirmed influenza infection | ≥14 days after initially booked vaccination/ information visit date up to 8 months |
| Laboratory-confirmed pneumococcal infection | ≥14 days after initially booked vaccination/ information visit date up to 8 months |
| Laboratory-confirmed COVID-19 infection | ≥14 days after initially booked vaccination/ information visit date up to 8 months |
| Cardio-respiratory mortality | ≥14 days after initially booked vaccination/ information visit date up to 8 months |
| Respiratory mortality | ≥14 days after initially booked vaccination/ information visit date up to 8 months |
| Cardiovascular mortality | ≥14 days after initially booked vaccination/ information visit date up to 8 months |
| In-hospital mortality | ≥14 days after initially booked vaccination/ information visit date up to 8 months |
| 30-day mortality following hospital discharge for primary endpoint | ≥14 days after initially booked vaccination/ information visit date up to 8 months |
| Hospitalization for RSV-related lower respiratory tract disease in subsequent 2025/2026 and 2026/2027 RSV seasons | From June 1, 2025 up to 12 months (2025/2026 season) and June 1, 2026 up to 12 months (2026/2027 season) |
| RSV-related respiratory tract disease hospitalization by chronic obstructive pulmonary disease status | Primary endpoint in patients with chronic obstructive pulmonary disease | ≥14 days after initially booked vaccination/ information visit date up to 8 months |
| New-onset dementia | ≥14 days after initially booked vaccination/ information visit date up to 10 years |
| RSV-related respiratory tract disease hospitalization by immunocompromised status | Stratified by immunocompromised status. Analysis will be carried out as outlined in C3761080, EU PASS register number EUPAS1000000480 | ≥14 days after initially booked vaccination/ information visit date up to 8 months |
| RSV-related lower respiratory tract disease hospitalization by immunocompromised status | Stratified by immunocompromised status. Analysis will be carried out as outlined in C3761080, EU PASS register number EUPAS1000000480 | ≥14 days after initially booked vaccination/ information visit date up to 8 months |
| All-cause respiratory tract disease hospitalization by immunocompromised status | Stratified by immunocompromised status. Analysis will be carried out as outlined in C3761080, EU PASS register number EUPAS1000000480 | ≥14 days after initially booked vaccination/ information visit date up to 8 months |
| All-cause lower respiratory tract disease hospitalization by immunocompromised status | Stratified by immunocompromised status. Analysis will be carried out as outlined in C3761080, EU PASS register number EUPAS1000000480 | ≥14 days after initially booked vaccination/ information visit date up to 8 months |
| RSV-related respiratory tract disease hospitalization by severe immunocompromised status | Stratified by severe immunocompromised status. Analysis will be carried out as outlined in C3761080, EU PASS register number EUPAS1000000480 | ≥14 days after initially booked vaccination/ information visit date up to 8 months |
| All-cause respiratory tract disease hospitalization by severe immunocompromised status | Stratified by severe immunocompromised status. Analysis will be carried out as outlined in C3761080, EU PASS register number EUPAS1000000480 | ≥14 days after initially booked vaccination/ information visit date up to 8 months |
| Atrial fibrillation hospitalization | Analysis will be carried out as outlined in C3761080, EU PASS register number EUPAS1000000480 | ≥14 days after initially booked vaccination/ information visit date up to 8 months |
| Hospitalization for any cardiac arrythmia | Analysis will be carried out as outlined in C3761080, EU PASS register number EUPAS1000000480 | ≥14 days after initially booked vaccination/ information visit date up to 8 months |
| Hospitalization for pericarditis | Analysis will be carried out as outlined in C3761080, EU PASS register number EUPAS1000000480 | ≥14 days after initially booked vaccination/ information visit date up to 8 months |
| Hospitalization for myocarditis | Analysis will be carried out as outlined in C3761080, EU PASS register number EUPAS1000000480 | ≥14 days after initially booked vaccination/ information visit date up to 8 months |
| Asthma exacerbation hospitalization | Analysis will be carried out as outlined in C3761080, EU PASS register number EUPAS1000000480 | ≥14 days after initially booked vaccination/ information visit date up to 8 months |
| RSV-related respiratory tract disease hospitalization by hepatic or renal impairment status | Among those with hepatic or renal impairment at baseline. Analysis will be carried out as outlined in C3761080, EU PASS register number EUPAS1000000480 | ≥14 days after initially booked vaccination/ information visit date up to 8 months |
| RSV-related MACE | ≥14 days after initially booked vaccination/ information visit date up to 8 months |
| Laboratory-confirmed mycoplasma infection | ≥14 days after initially booked vaccination/ information visit date up to 8 months |
| Laboratory-confirmed HMPV infection | ≥14 days after initially booked vaccination/ information visit date up to 8 months |
| RSV-related tract disease hospitalization/emergency department visit | ≥14 days after initially booked vaccination/ information visit date up to 8 months |
| Critical lower respiratory tract disease hospitalization | ≥14 days after initially booked vaccination/ information visit date up to 8 months |
| Critical respiratory tract disease hospitalization | ≥14 days after initially booked vaccination/ information visit date up to 8 months |
| RSV-related COPD exacerbation | ≥14 days after initially booked vaccination/ information visit date up to 8 months |
| All-cause COPD exacerbation | ≥14 days after initially booked vaccination/ information visit date up to 8 months |
| Asthma exacerbation | ≥14 days after initially booked vaccination/ information visit date up to 8 months |
| RSV-related asthma exacerbation | ≥14 days after initially booked vaccination/ information visit date up to 8 months |
| Danske Lægers Vaccinations Service | Søborg | 2860 | Denmark |
| General Public Health Directorate of Galician Health Service | Santiago de Compostela | A Coruña | Spain |
| Derived |
| 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. |
| 40738309 | Derived | 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. |