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

NCT07122661 | Active Not Recruiting FDA Drug

• 1 other identifier: C3671066
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Respiratory Syncytial Virus (RSV); Respiratory Syncytial Virus; Lower Respiratory Tract Disease; Respiratory Tract Diseases; Acute Respiratory Illness (ARI)

Keywords

RSVpreF; Vaccine; Effectiveness; Vaccine Effectiveness; Pregnancy; Maternal; Immunization; Maternal Immunization; ABRYSVO; Respiratory Syncytial Virus; Lower Respiratory Tract Disease; Infants; Hospitalized; Hospitalization; Test Negative Design; Case Control; Retrospective; Respiratory Outcomes; Prefusion F protein-based; Acute Respiratory Illness

Outcome Measures

Primary Outcomes (1)

• Estimate vaccine effectiveness of ABRYSVO during pregnancy against RSV-positive lower respiratory tract disease hospitalisation among infants.

  RSV-positive lower respiratory tract disease hospitalisation occurring 0 to ≤180 days after birth.

  From birth through 6 months (0 to ≤180 days) of age.

Secondary Outcomes (3)

• 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 within key subgroups.

• Estimate vaccine effectiveness of ABRYSVO during pregnancy against RSV-positive severe lower respiratory tract disease hospitalisation among infants.

  From birth through 6 months (0 to ≤180 days) of age and within key subgroups.

• Estimate vaccine effectiveness of ABRYSVO during pregnancy against RSV-positive acute respiratory illness hospitalisation among infants.

  From birth through 6 months (0 to ≤180 days) of age and within key subgroups.

Study Arms (2)

Cases

Infants who meet the respiratory clinical case definition and test positive for RSV (result obtained from standard of care testing with specimen collected within 10 days prior to hospital admission through 3 days after a hospital admission).

Biological: ABRYSVO

Controls

Infants who meet the respiratory clinical case definition and test negative for RSV (result obtained from standard of care testing with specimen collected within 10 days prior to hospital admission through 3 days after a hospital admission).

Biological: ABRYSVO

Interventions

ABRYSVO BIOLOGICAL

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.

Also known as: RSVpreF, RSV Prefusion F

Cases; Controls

Eligibility Criteria

• Age: 0 Years - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

This hospital-based retrospective study will be conducted in up to 9 hospitals across 6 states/territories in Australia, supported by the Paediatric Active Enhanced Diseases Surveillance Network. Given the retrospective nature of this study, hospitals that already function as national sentinel units for respiratory virus surveillance, or have robust clinical, laboratory or epidemiological surveillance will be included. Each participating hospital conducts year-round standard of care testing for acute respiratory illness which includes respiratory virus panel test using PCR. Study will include all infants through 12 months of age who were admitted to one of the participating hospitals with symptoms of respiratory infection, met the clinical case definition of acute respiratory illness, and had a respiratory specimen collected within 10 days prior to hospital admission through 3 days after a hospital admission with an RSV test result through standard of care testing.

You may qualify if:

• Infant ≤12 months (≤360 days) of age on the hospitalisation date.
• Index date within the time period for data collection (approximately 01 March 2025 - 28 February 2027)
• 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.
• Infant born to a birth mother eligible to receive ABRYSVO vaccination, with infant date of birth on or after 17 February 2025.

You may not qualify if:

• Participants meeting any of the following criteria will not be included in the study:
• Infant born at \<28 weeks and 0/7 days of gestational age.
• Infant received any licensed or investigational RSV preventive product (e.g., palivizumab, nirsevimab, active RSV vaccine) since birth.
• Infant received ≥1 blood transfusion or other blood products containing antibody (e.g., fresh frozen plasma) since birth.
• Infant born to a birth mother who received any other licensed or investigational RSV vaccine during this pregnancy.
• Infant born to a birth mother for whom ABRYSVO vaccination status cannot be confirmed in available data sources.

Sponsors & Collaborators

• Pfizer: lead
• The Kids Research Institute Australia on behalf of the Centre for Child Health Research, University of Western Australia: collaborator

Study Sites (1)

Pfizer

Sydney, Australia

Location

MeSH Terms

Conditions

Respiratory Tract Diseases

Interventions

abrysvo

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: August 14, 2025
• Study Start: August 11, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)