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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)

Study acronym: STREETON
StatusActive, Not Recruiting
PhaseNot specified
SponsorPfizer
Started
View on ClinicalTrials.gov ↗

Record History

  1. Site details revisedv4
  2. Re-verified, no change to tracked fieldsv3
  3. Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Study sites: 0 to 1
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Pfizer
436 trials monitored
See 32 trials at risk
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.
Trial Details
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
(from sponsor)		 Respiratory Syncytial Virus (RSV), Respiratory Syncytial Virus, Lower Respiratory Tract Disease, Respiratory Tract Diseases, Acute Respiratory Illness (ARI)
Related terms Respiratory Tract Diseases
Enrollment 1 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov