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Completed

NCT Number: NCT07164430

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

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.

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Key information

Conditions

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

Age range

Up to 2 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Canberra Hospital

Garran, Australian Capital Territory, 2605, Australia

About this study

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:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • child aged under 2 years
  • laboratory confirmed RSV

Exclusion criteria

  • n/a

Treatment and study plan

Primary outcomes

  1. RSV Hospitalisation

    Time frame: At monthly time intervals over 3 years and 8 months

    RSV-related hospital admissions will be determined by reviewing hospital admissions occurring within one month of a positive RSV test. The discharge summary will be reviewed for a diagnosis or other clinical information consistent with RSV-related illness (bronchiolitis, respiratory tract infection, viral illness), and cross-checked with the ICD-10-AM coding for the episode.

Secondary outcomes

  1. Emergency Department presentations

    Time frame: Monthly time intervals over a period of 3 years and 8 months

    RSV-related ED presentations will be determined by reviewing ED presentations occurring within one month of a positive RSV test. Documentation from the presentation will be reviewed for a discharge diagnosis or impression consistent with RSV-related illness (bronchiolitis, respiratory tract infection, viral illness). If no discharge letter or doctors' documentation is available, the triage note will be reviewed for a presenting complaint consistent with RSV-related illness (rhinorrhoea, nasal congestion, cough, respiratory distress, diffuse crackles and/or wheeze, fever, hypoxaemia, and associated feeding difficulties, vomiting, dehydration, or lethargy).

  2. RSV cases

    Time frame: At monthly intervals over 3 years and 8 months

    RSV cases will be determined by laboratory notifications of positive RSV infection on PCR test to ACT Health, the body responsible for receiving notifiable disease notifications.

Sponsors and collaborators

Lead sponsor

Nicola Irwin

Other

Collaborators

  • Kirby Institute
  • The University of New South Wales

Registry information

Official study title

The Impact of Infant and Maternal Immunoprophylaxis on Hospitalisation for Respiratory Syncytial Virus in the Australian Capital Territory: A Population-based Interrupted Time Series Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 10, 2025
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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