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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,792 (actual)
• Sponsor: Nicola Irwin · Academic / Other
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

Summary

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

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

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

Timeline

• Start date: 2025-09-22
• Primary completion: 2026-01-31
• Completion: 2026-01-31
• First posted: 2025-09-10
• Last updated: 2026-03-05

Locations

1 site across 1 country: Australia