STudy of Real world vaccinE Effectiveness of maTernal RSVpreF vaccinatiON against respiratory syncytial virus (RSV) in hospitalised infants in Australia (STREETON)

Study identification

• EU PAS number:
  EUPAS1000000598
• Study ID:
  1000000598
• Official title and acronym:
  STudy of Real world vaccinE Effectiveness of maTernal RSVpreF vaccinatiON against respiratory syncytial virus (RSV) in hospitalised infants in Australia (STREETON)
• DARWIN EU® study:
  No
• Study countries:
  Australia
• Study description:
  This Pfizer-sponsored real-world retrospective non-interventional (NI) study will be conducted within a research network comprised of independent hospitals across Australia using data collected during routine standard of care (SOC) clinical encounters available in health records (including both digital and/or paper records), supplemented with information from the official national immunisation registry, the Australian Immunisation Register (AIR). Additional data from accredited pathology laboratories will be included. ; There will be no active enrollment of study participants, no direct contact with study participants, and no collection of any primary data outside of the SOC. ; This study will use a test negative design (TND) to evaluate real-world vaccine effectiveness (VE) of ABRYSVO vaccination during pregnancy against RSV-associated outcomes in infants.
• Study status:
  Ongoing

Study timelines

Date when funding contract was signed

Planned:01/07/2025

Actual:30/06/2025

Study start date

Planned:11/08/2025

Actual:11/08/2025

Date of final study report

Planned:30/07/2027

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only