The Impact of the 2025 Infant and Maternal Respiratory Syncytial Virus (RSV) Prevention Program on RSV-related Hospitalisations in the Australian Capital Territory

NCT ID: NCT07164430

Last Updated: 2025-09-10

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

2100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-30

Study Completion Date

2025-12-31

Brief Summary

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The goal of this observational study is to is to examine the impact of new RSV prevention medicines on the burden of RSV disease among young children. The main question it aims to answer is:

What was the impact of the 2025 RSV prevention program on RSV-related hospitalisation in children under 2 years of age?

Participants won't need to do anything additional for the study as only routinely collected health information will be used to answer the research question.

Detailed Description

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Nirsevimab, a novel long-acting monoclonal antibody targeted at RSV became available for vulnerable babies in the Australian Capital Territory (a small jurisdiction in Australia) in April 2024. Maternal RSV vaccine, Abrysvo, became available for all women of 28-36 weeks gestation in February 2025. Through either nirsevimab or Abrysvo, all infants born from 1 January 2025 in the jurisdiction have universal eligibility for RSV immunoprophylaxis.

This study will use interrupted time series methodology to evaluate the impact of the 2025 RSV prevention program on RSV-related hospitalisation in children under 2 years of age. Historical data from 2022-2023 will form the pre-nirsevimab period, and 2022-2024 the pre-Abrysvo period. 2025 will form the post-intervention period.

Secondary objectives are to:

1. Evaluate the impact of the 2025 RSV prevention program on RSV-related Emergency Department (ED) presentations
2. Evaluate the impact on the reported incidence of RSV

Conditions

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Respiratory Syncytial Virus (RSV) Infection Respiratory Syncytial Virus Hospitalizations Respiratory Syncytial Virus Immunization

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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RSV cases

Children aged under 2 years with laboratory confirmed RSV infection

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* child aged under 2 years
* laboratory confirmed RSV

Exclusion Criteria

* n/a
Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nicola Irwin

OTHER

Sponsor Role lead

Responsible Party

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Nicola Irwin

Clinical Support Nurse

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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The Canberra Hospital

Garran, Australian Capital Territory, Australia

Site Status

Countries

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Australia

Central Contacts

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Nicola Irwin, PhD

Role: CONTACT

+61 481 396 197

Other Identifiers

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2025.LRE.00223

Identifier Type: -

Identifier Source: org_study_id

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