STudy of Real World vaccinE Effectiveness of maTernal RSVpreF vaccinatiON Against Respiratory Syncytial Virus (RSV) in Hospitalised Infants in Australia (STREETON)
ABRYSVO: This is a non-interventional retrospective study; therefore, ABRYSVO vaccine has already been administered according to the standard of care. ABRYSVO is a bivalent RSV prefusion F protein-based vaccine (RSVpreF) composed of two prefusion F proteins to protect against both RSV-A and RSV-B.
Study summary
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.
Eligibility
Sex
ALL
Min age
0 Years
Max age
12 Months
Healthy volunteers
No
Inclusion Criteria:
Participants must meet all of the following inclusion criteria to be eligible for inclusion in the study:
1. Infant ≤12 months (≤360 days) of age on the hospitalisation date.
2. Index date within the time period for data collection (approximately 01 March 2025 - 28 February 2027)
3. Hospitalised with acute respiratory illness meeting the protocol-defined clinical case definition, and for whom RSV testing results from a specimen collected 10 days prior to hospital admission through 3 days after a hospital admission are known.
4. Infant born to a birth mother eligible to receive ABRYSVO vaccination, with infant date of birth on or after 17 February 2025.
Exclusion Criteria:
Participants meeting any of the following criteria will not be included in the study:
1. Infant born at \<28 weeks and 0/7 days of gestational age.
2. Infant received any licensed or investigational RSV preventive product (e.g., palivizumab, nirsevimab, active RSV vaccine) since birth.
3. Infant received ≥1 blood transfusion or other blood products containing antibody (e.g., fresh frozen plasma) since birth.
4. Infant born to a birth mother who received any other licensed or investigational RSV vaccine during this pregnancy.
5. Infant born to a birth mother for whom ABRYSVO vaccination status cannot be confirmed in available data sources.
Primary outcome measure(s)
Estimate vaccine effectiveness of ABRYSVO during pregnancy against RSV-positive lower respiratory tract disease hospitalisation among infants. — From birth through 6 months (0 to ≤180 days) of age. RSV-positive lower respiratory tract disease hospitalisation occurring 0 to ≤180 days after birth.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.
