Duration of Protection of Nirsevimab Against Hospitalisation for Respiratory Syncytial Virus Infection
NCT ID: NCT06993753
Last Updated: 2025-05-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
4350 participants
OBSERVATIONAL
2024-04-15
2027-03-31
Brief Summary
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A case-control study will be conducted using routinely collected linked data. Cases will be children born in Queensland from 15 April 2024 to 14 April 2025 who are hospitalised with an RSV-related condition prior to 14 April 2026. Controls will be drawn from the set of infants who are admitted to the same hospital in a 5:1 ratio, and matched on age and sex using the Queensland Perinatal Data Collection. Nirsevimab receipt will be extracted from hospital's electronic medical records and linked to hospitalization data by the Queensland Health Data Linkage Unit. Duration of protection against RSV-related hospitalisation due to nirsevimab will be assessed using multivariable logistic regression model accounting for matching and adjusting for confounding variables.
This case-control study will determine the level and duration of protection offered by nirsevimab in a region with year-round RSV circulation and inform future prevention strategies. Interim analysis is expected to be available at the time of the conference, allowing for early dissemination of this first evidence about nirsevimab duration of protection beyond 180 days.
Funding: From Sanofi and AstraZeneca through a collaboration grant.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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RSV hospitalised infant
Description: Cases (RSV hospitalised infant) will be children born in Queensland from 15 April 2024 to 14 April 2025 who are hospitalised with a RSV-related condition prior to 14 April 2026. Nirsevimab receipt will be extracted from hospital's electronic medical records and linked to hospitalisation data by the Queensland Health Data Linkage Unit.
No interventions assigned to this group
Non-RSV hospitalised infant
Description: Controls (Non-RSV hospitalised infant) will be drawn from the set of infants who are admitted to the same hospital in a 5:1 ratio, and matched on age and sex using the Queensland Perinatal Data Collection. Nirsevimab receipt will be extracted from hospital's electronic medical records and linked to hospitalization data by the Queensland Health Data Linkage Unit.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria: Infants who admitted to hospitals with an elective admission. ((i.e. admissions that are planned ahead of time, such as scheduled surgeries or other pre-arranged medical procedures).
1 Year
ALL
No
Sponsors
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Griffith University
OTHER
Responsible Party
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Asmaa El-Heneidy
Dr
Locations
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Griffith University
Gold Coast, Queensland, Australia
Countries
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Other Identifiers
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VAS00012
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2024/851
Identifier Type: -
Identifier Source: org_study_id
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