A Study to Evaluate the Vaccine Effectiveness of Abrysvo® for Preventing RSV Hospitalizations in Adults Aged 60 Years or Above (Complementary Study to DAN-RSV)

Study identification

• EU PAS number:
  EUPAS1000000480
• Study ID:
  1000000480
• Official title and acronym:
  A Study to Evaluate the Vaccine Effectiveness of Abrysvo® for Preventing RSV Hospitalizations in Adults Aged 60 Years or Above (Complementary Study to DAN-RSV)
• DARWIN EU® study:
  No
• Study countries:
  Denmark
• Study description:
  The primary objective is to evaluate Abrysvo® vaccine effectiveness (VE) against hospitalization for RSV-related respiratory tract disease in adults aged 60 and older stratified by immunocompromised status.
• Study status:
  Planned

Research institutions and networks

Institutions

Copenhagen University Hospital – Herlev and Gentofte

Study timelines

Date when funding contract was signed

Planned:30/05/2025

Study start date

Planned:31/05/2025

Data analysis start date

Planned:31/05/2025

Date of interim report, if expected

Planned:30/09/2025

Date of final study report

Planned:31/12/2027

Sources of funding

Pharmaceutical company and other private sector 

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

C3671080