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

NCT07122661 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 1

Last updated 2025-11-19

No results posted yet for this 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.

Conditions

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

Interventions

BIOLOGICAL

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.

Sponsors & Collaborators

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

    collaborator UNKNOWN

  • Pfizer

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Eligibility

Min Age
0 Years
Max Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-11
Primary Completion
2027-04-30
Completion
2027-04-30
FDA Drug
Yes

Countries

  • Australia

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07122661 on ClinicalTrials.gov