Clinical trial • Phase IV • Infectious Disease

Respiratory syncytial virus, subgroup A, stabilized prefusion F protein 847A | Respiratory syncytial virus, subgroup B, stabilized prefusion F protein 847B for Respiratory syncytial virus infection

Phase IV trial of Respiratory syncytial virus, subgroup A, stabilized prefusion F protein 847A | Respiratory syncytial virus, subgroup B, stabilized prefu…

Overview

Trial Therapeutic Area
Infectious Disease
Trial Disease
Respiratory syncytial virus infection
Trial Stage
Phase IV
Drug Modality
Vaccine

Key dates

Initial CTIS Submission Date
10-08-2024
First CTIS Authorization Date
14-10-2024

Trial design

Randomised, no vaccine (no intervention)-controlled Phase IV trial across 3 sites in Denmark, Spain.

Randomised
Yes
Comparator
No vaccine (no intervention)
Target Sample Size
890000

Eligibility

Recruits 890000 No vulnerable populations selected. Informed consent form must be signed and dated by participants..

Vulnerable Population
No vulnerable populations selected. Informed consent form must be signed and dated by participants.

Inclusion criteria

  • {"criterion_text":"- Age 18 years and above\n- Informed consent form has been signed and dated\n- 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

  • {"criterion_text":"- There are no specific exclusion criteria for this study"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Hospitalization for RSV-related respiratory tract disease","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Hospitalization for RSV-related respiratory tract disease evaluated among the as-treated study population with balanced follow up time between study arms (key secondary)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- RSV-related lower respiratory tract disease hospitalization (key secondary)","definition_or_measurement_approach":"LRTD is defined by presence of any lower respiratory tract infection (LRTI), or exacerbations of chronic pulmonary disease (COPD, asthma) or congestive heart failure."}
  • {"endpoint_text":"- Stratifications of the primary endpoint by a.\tAge group (60-74 and 75+) b. Subsequent seasons (2025/2026 and 2026/2027 RSV seasons)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- RSV-related hospitalization","definition_or_measurement_approach":""}
  • {"endpoint_text":"- All-cause respiratory tract disease hospitalization (key secondary)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- RSV-related cardio-respiratory hospitalizations","definition_or_measurement_approach":""}
  • {"endpoint_text":"- All-cause cardio-respiratory hospitalizations","definition_or_measurement_approach":""}
  • {"endpoint_text":"- All-cause lower respiratory tract disease hospitalization","definition_or_measurement_approach":""}
  • {"endpoint_text":"- All-cause hospitalization","definition_or_measurement_approach":""}
  • {"endpoint_text":"- All-cause death","definition_or_measurement_approach":""}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
890000
Recruitment Window Months
42
Consent Approach
Informed consent form must be signed and dated by each participant. Subject information and informed consent documents are provided (documents listed in CTIS). Consent materials available in Danish and English for Denmark; Spanish and Galician for Spain. Video transcripts and online participant information are provided. No assent procedures specified (adult participants only).

Methods

  • Invitation letters to potential participants (document: 'Invitation letter season 2025-2026') — materials present for associated entities in Denmark (associatedEntityId 242124) and Spain (associatedEntityId 253291).
  • Website advertisement (documents: 'Website-advertisement', 'K2_recruitment material_website') — online recruitment/information for potential participants.
  • SMS invitations (document: 'K2_recruitment material_SMS') — digital outreach to participants.
  • Posters (document: 'K2_recruitment material_poster') — physical recruitment materials.
  • Informational video and transcript (documents: 'Video-transcript', 'K2_recruitment material_Texto video informativo') — multimedia information for participants.
  • Communication to healthcare professionals (document: 'K2_recruitment material_comunicacion profesionales sanitarios') — engagement of clinicians to support recruitment.

Geography

Total Number Of Sites
3
Total Number Of Participants
890000

Denmark

Earliest CTIS Part Ii Submission Date
09-10-2024
Latest Decision Or Authorization Date
17-09-2025
Processing Time Days
343
Number Of Sites
2
Number Of Participants
690000

Sites

Site Name
Danske Lægers Vaccinations Service
Department Name
Danske Lægers Vaccinations Service
Principal Investigator Name
Carsten Schade Larsen
Principal Investigator Email
carsten.schade.larsen@dadlnet.dk
Contact Person Name
Carsten Schade Larsen
Site Name
Gentofte Hospital
Department Name
Department of Cardiology
Principal Investigator Name
Tor Biering-Sørensen
Principal Investigator Email
tor.biering-soerensen@regionh.dk
Contact Person Name
Tor Biering-Sørensen

Spain

Earliest CTIS Part Ii Submission Date
28-10-2025
Latest Decision Or Authorization Date
03-11-2025
Processing Time Days
6
Number Of Sites
1
Number Of Participants
200000

Sites

Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Pediatrics
Principal Investigator Name
Federico Martinon Torres
Principal Investigator Email
federico.martinon.torres@sergas.es
Contact Person Name
Federico Martinon Torres

Sponsor

Primary sponsor

Full Name
Gentofte Hospital
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Denmark

Third parties

  • {"country":"Denmark","full_name":"GCP-enheden ved Københavns Universitetshospital","duties_or_roles":"sponsorDuties code: 1","organisation_type":"Health care"}

Co-sponsors

  • Pfizer Inc.

Investigational products

Investigational Product Name
Abrysvo powder and solvent for solution for injection Respiratory syncytial virus vaccine (bivalent, recombinant)
Active Substance
Respiratory syncytial virus, subgroup A, stabilized prefusion F protein 847A | Respiratory syncytial virus, subgroup B, stabilized prefusion F protein 847B
Modality
Vaccine
Routes Of Administration
INTRAMUSCULAR INJECTION
Route
Intramuscular injection
Authorisation Status
Authorised (Marketing authorisation: EU/1/23/1752/001)

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