Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
890,000
Countries
2
Sites
3
RSV-infection
To evaluate Abrysvo® effectiveness in reducing the risk of RSV-related respiratory tract disease hospitalization in adults aged 18 and older.
Key facts
- Sponsor
- Gentofte Hospital, Pfizer Inc.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02]
- Trial duration
- 18 Nov 2024 → ongoing
- Decision date (initial)
- 2024-10-14
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Pfizer
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Prophylaxis, Safety, Efficacy
To evaluate Abrysvo® effectiveness in reducing the risk of RSV-related respiratory tract disease hospitalization in adults aged 18 and older.
Secondary objectives 1
- The secondary objectives of the study are to evaluate Abrysvo® effectiveness in reducing the risk of the following endpoints in adults aged 60 and older: 1. RSV-related respiratory tract disease hospitalization (same as primary endpoint) in the as-treated study population with balanced follow up time between study arms (key secondary). 2. RSV-related LRTD hospitalizations (key secondary). LRTD is defined by presence of any lower respiratory tract infection (LRTI), or exacerbations of chronic pulmonary disease (COPD, asthma) or congestive heart failure. 3. The primary endpoint stratified by: a. Age group (60-74 and 75+) b. Subsequent seasons (2025/2026 and 2026/2027 RSV seasons) 4.RSV-related hospitalizations 5. All-cause respiratory tract disease hospitalization (key secondary) 6. RSV-related cardio-respiratory hospitalizations 7. All-cause cardio-respiratory hospitalizations 8.All-cause lower respiratory tract disease hospitalization 9.All-cause hospitalization 10.All-cause death.
Conditions and MedDRA coding
RSV-infection
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10039247 | RSV infection | 10021881 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Age 18 years and above
- Informed consent form has been signed and dated
- No prior participantion in the DAN-RSV trial (participants included in the season 2024/2025 season cannot re-enter in the 2025/2026 season)
Exclusion criteria 1
- There are no specific exclusion criteria for this study
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Hospitalization for RSV-related respiratory tract disease
Secondary endpoints 10
- Hospitalization for RSV-related respiratory tract disease evaluated among the as-treated study population with balanced follow up time between study arms (key secondary)
- RSV-related lower respiratory tract disease hospitalization (key secondary)
- Stratifications of the primary endpoint by a. Age group (60-74 and 75+) b. Subsequent seasons (2025/2026 and 2026/2027 RSV seasons)
- RSV-related hospitalization
- All-cause respiratory tract disease hospitalization (key secondary)
- RSV-related cardio-respiratory hospitalizations
- All-cause cardio-respiratory hospitalizations
- All-cause lower respiratory tract disease hospitalization
- All-cause hospitalization
- All-cause death
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD10762418 · Product
- Active substance
- Respiratory Syncytial Virus, Subgroup a, Stabilized Prefusion F Protein 847A
- Substance synonyms
- PF-06928316 (847A), RSV subgroup A stabilized prefusion F protein (847A)
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 1 µg microgram(s)
- Max total dose
- 1 µg microgram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J07BX05 — -
- Marketing authorisation
- EU/1/23/1752/001
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Gentofte Hospital
- Sponsor organisation
- Gentofte Hospital
- Address
- Gentofte Hospitalsvej 1
- City
- Hellerup
- Postcode
- 2900
- Country
- Denmark
Scientific contact point
- Organisation
- Gentofte Hospital
- Contact name
- Tor Biering-Sørensen
Public contact point
- Organisation
- Gentofte Hospital
- Contact name
- Sine Højlund Christensen
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| GCP-enheden ved Københavns Universitetshospital ORL-000001661
|
Frederiksberg, Denmark | On site monitoring |
Pfizer Inc.
- Sponsor organisation
- Pfizer Inc.
- Address
- 235 East 42nd Street
- City
- New York
- Postcode
- 10017-5703
- Country
- United States
Sponsor responsibilities
- Article 77 compliance
- Gentofte Hospital
- Contact point sponsor
- Gentofte Hospital
- Article 77 implementation
- Gentofte Hospital
Locations
2 EU/EEA countries · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 690,000 | 2 |
| Spain | Ongoing, recruitment ended | 200,000 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Gentofte Hospital
Department of Cardiology, Gentofte Hospitalsvej 1, 2900, Hellerup
Danske Lægers Vaccinations Service
Danske Lægers Vaccinations Service, Gladsaxevej 376. 1., 2860, Søborg
Complexo Hospitalario Universitario De Santiago
Pediatrics, Calle Choupana Da S/n, 15706, Santiago De Compostela
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2024-11-18 | 2024-11-18 | |||
| Spain | 2025-11-20 | 2025-11-20 | 2026-02-28 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 38 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_protocol EU CT 2024-516600-42-00 | 8.1 |
| Protocol (for publication) | DAN-RSV protocol EU CT 2024-516600-42-00_TC | 8.1 |
| Recruitment arrangements (for publication) | Invitation letter season 2025-2026 | 4.5 |
| Recruitment arrangements (for publication) | Invitation letter season 2025-2026_TC | 4.5 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed consent procedure | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed consent procedure_TC | 2 |
| Recruitment arrangements (for publication) | K1_recruitment arrangement | 3.4 |
| Recruitment arrangements (for publication) | K1_recruitment arrangement_TC | 3.4 |
| Recruitment arrangements (for publication) | K2_recruitment material_comunicacion profesionales sanitarios | 1.0 |
| Recruitment arrangements (for publication) | K2_recruitment material_Documento preguntas y respuestas | 2.0 |
| Recruitment arrangements (for publication) | K2_recruitment material_Documento preguntas y respuestas_TC | 2.0 |
| Recruitment arrangements (for publication) | K2_recruitment material_poster | 2.0 |
| Recruitment arrangements (for publication) | K2_recruitment material_poster_TC | 2.0 |
| Recruitment arrangements (for publication) | K2_recruitment material_SMS | 2.0 |
| Recruitment arrangements (for publication) | K2_recruitment material_SMS_TC | 2.0 |
| Recruitment arrangements (for publication) | K2_recruitment material_Texto video informativo | 2.0 |
| Recruitment arrangements (for publication) | K2_recruitment material_Texto video informativo_TC | 2.0 |
| Recruitment arrangements (for publication) | K2_recruitment material_website | 2.0 |
| Recruitment arrangements (for publication) | K2_recruitment material_website_TC | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment materials description | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment materials description_TC | 2.0 |
| Recruitment arrangements (for publication) | Website-advertisement | 3.4 |
| Recruitment arrangements (for publication) | Website-advertisement_TC | 3.4 |
| Subject information and informed consent form (for publication) | Deltagerinformation DAN-RSV 2025-2026 season _TC | 5.3 |
| Subject information and informed consent form (for publication) | L1_Deltagerinformation season 2025-2026 | 5.3 |
| Subject information and informed consent form (for publication) | L1_Samtykkeerklring sson 2025-2026 | 2.2 |
| Subject information and informed consent form (for publication) | L1_Samtykkeerklring sson 2025-2026_TC | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Galician | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Galician_TC | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Spanish | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Spanish_TC | 3.0 |
| Subject information and informed consent form (for publication) | L1_Video-transcript | 4.3 |
| Subject information and informed consent form (for publication) | Participant information DAN-RSV_ENGLISH_TC | 3.1 |
| Subject information and informed consent form (for publication) | Video-transcript_TC | 4.3 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Abrysvo | 2.0 |
| Synopsis of the protocol (for publication) | D1_DAN-RSV Protocol-synopsis_TC | 3.1 |
| Synopsis of the protocol (for publication) | D1_DAN-RSV_EU CT 2024-516600-42-00_Spanish synopsis | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol-synopsis | 3.1 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-10 | Denmark | Acceptable 2024-10-11
|
2024-10-14 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-10-17 | Denmark | Acceptable 2024-11-08
|
2024-11-08 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-11-21 | Denmark | Acceptable 2024-11-28
|
2024-11-28 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-05-26 | Denmark | Acceptable 2025-06-16
|
2025-06-16 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-07-30 | Denmark | Acceptable 2025-09-17
|
2025-09-17 |
| 6 | SUBSEQUENT ADDITION OF MSC | APP-6 | 2025-09-26 | 2025-11-03 |