Effectiveness and Impact of Nirsevimab on medium to long-term RSV associated outcomes in Finland – Population-based registry study (RSV506)

Study identification

• EU PAS number:
  EUPAS1000001045
• Study ID:
  1000001045
• Official title and acronym:
  Effectiveness and Impact of Nirsevimab on medium to long-term RSV associated outcomes in Finland – Population-based registry study (RSV506)
• DARWIN EU® study:
  No
• Study countries:
  Finland
• Study description:
  Respiratory syncytial virus (RSV) causes substantial respiratory disease burden in infants, and nirsevimab was introduced in Finland in 2024 to prevent RSV disease during the first RSV season. This population-based nationwide register study evaluates the real-world effectiveness and impact of universal nirsevimab immunoprophylaxis in Finland. The primary cohort includes infants eligible for nirsevimab during the 2024–2025 RSV season. Effectiveness will be assessed by comparing immunized and non-immunized eligible infants. Population impact will be assessed using before–after comparisons with historical birth cohorts. Outcomes include RSV-related respiratory disease, antibiotic use, otitis media, recurrent wheezing, and asthma. Individual-level national register data will be linked using personal identity codes.; ;
• Study status:
  Planned

Research institutions and networks

Institutions

FVR – Finnish Vaccine Research

Finland

Study timelines

Date when funding contract was signed

Planned:15/09/2025

Study start date

Planned:02/07/2026

Date of final study report

Planned:31/12/2029

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Sanofi Winthrop Industrie

Regulatory

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