Ignite Creation Date:
2025-12-24 @ 12:35 PM
Ignite Modification Date:
2026-01-01 @ 3:33 AM
Study NCT ID:
NCT07122661
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-19
First Post:
2025-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
STudy of Real World vaccinE Effectiveness of maTernal RSVpreF vaccinatiON Against Respiratory Syncytial Virus (RSV) in Hospitalised Infants in Australia (STREETON)
Sponsor:
Pfizer
Organization:
Study Overview
Official Title:
STudy of Real World vaccinE Effectiveness of maTernal RSVpreF vaccinatiON Against Respiratory Syncytial Virus (RSV) in Hospitalised Infants in Australia
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STREETON
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.
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.
Detailed Description:
This case-control study using a test negative design 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.
The primary objective is to estimate vaccine effectiveness (VE) of ABRYSVO during pregnancy against RSV-positive lower respiratory tract disease (LRTD) hospitalisation among infants from birth through 6 months (0 to ≤180 days) of age.
Baseline characteristics of the study population will be described by case/control status and by maternal RSVpreF vaccination status. Standardised mean differences may be used to compare the distributions (absolute differences \>0.10 will be considered meaningful). For all VE objectives, we will use a logistic regression model to compare the odds of maternal ABRYSVO vaccination during pregnancy between test-positive cases and test-negative controls, generating an odds ratio (OR) and 95% CI and we will use multivariable logistic regression to compute an adjusted OR (aOR), from which we will derive final VE estimates, adjusted for potential confounding, according to the formula: VE = (1-aOR) x 100%.
The primary objective is to estimate vaccine effectiveness (VE) of ABRYSVO during pregnancy against RSV-positive lower respiratory tract disease (LRTD) hospitalisation among infants from birth through 6 months (0 to ≤180 days) of age.
Baseline characteristics of the study population will be described by case/control status and by maternal RSVpreF vaccination status. Standardised mean differences may be used to compare the distributions (absolute differences \>0.10 will be considered meaningful). For all VE objectives, we will use a logistic regression model to compare the odds of maternal ABRYSVO vaccination during pregnancy between test-positive cases and test-negative controls, generating an odds ratio (OR) and 95% CI and we will use multivariable logistic regression to compute an adjusted OR (aOR), from which we will derive final VE estimates, adjusted for potential confounding, according to the formula: VE = (1-aOR) x 100%.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: