STudy of Real World vaccinE Effectiveness of maTernal RSVpreF vaccinatiON Against Respiratory Syncytial Virus (RSV) in Hospitalised Infants in Australia (STREETON)

This Pfizer-sponsored real-world retrospective non-interventional study will be conducted within a research network comprised of independent hospitals across Australia using data collected during routine standard of care clinical encounters available in health records, supplemented with information from the official national immunisation registry, the Australian Immunisation Register. 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 standard of care. This study will use a test negative design to evaluate real-world vaccine effectiveness of RSVpreF vaccination during pregnancy against RSV-associated outcomes in infants.

NCT Number	NCT07122661
Lead Sponsor	Pfizer Collaborators: The Kids Research Institute Australia on behalf of the Centre for Child Health Research, University of Western Australia
Conditions	Respiratory Syncytial Virus (RSV), Respiratory Syncytial Virus, Lower Respiratory Tract Disease, Respiratory Tract Diseases, Acute Respiratory Illness (ARI)
Enrollment	1 participants
Start Date	2025-08-11
Primary Completion	2027-04-30 (estimated)
Study Completion	2027-04-30 (estimated)
Updated on ClinicalTrials.gov	2025-11-19