Respiratory Syncytial Virus (RSV) InfectionNCT07164430
The Impact of the 2025 Infant and Maternal Respiratory Syncytial Virus (RSV) Prevention Program on RSV-related Hospitalisations in the Australian Capital Territory
An observational study of Respiratory Syncytial Virus (RSV) Infection and Respiratory Syncytial Virus Hospitalizations, run by Nicola Irwin at 1 site in Australia.
Trial 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?… Read more about this study
- Who is it for?
- Ages Up to 2 years
- Conditions the study is for
- Respiratory Syncytial Virus (RSV) Infection, Respiratory Syncytial Virus Hospitalizations, Respiratory Syncytial Virus Immunization
- How many people
- 2,792 participants
- Where
- 1 siteAustralia
- Study dates
- 22 Sep 2025to 31 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 2 years
- All sexes
- No healthy volunteers
- Child
Study population: The study is set in the Australian Capital Territory, a small Australian jurisdiction with a single acute paediatric service provider.
Who may be able to join
- child aged under 2 years
- laboratory confirmed RSV
Who cannot join
- n/a
Trial locations and contacts
1 site in 1 country.
Australia1 site
The Canberra Hospital
Garran, Australian Capital Territory, 2605
About this study
Official 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
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.
Read the 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:
- 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
- Conditions
- Respiratory Syncytial Virus (RSV) Infection, Respiratory Syncytial Virus Hospitalizations, Respiratory Syncytial Virus Immunization
- Keywords
- Interrupted Time Series Analysis, Epidemiologic Methods
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| RSV cases | Children aged under 2 years with laboratory confirmed RSV infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
RSV Hospitalisation
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.
Measured: At monthly time intervals over 3 years and 8 months
Secondary outcomes (2)
Emergency Department presentations
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).
Measured: Monthly time intervals over a period of 3 years and 8 months
RSV cases
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.
Measured: At monthly intervals over 3 years and 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start22 Sep 2025
- Primary completion31 Jan 2026
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial Virus (RSV) InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 2,792 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nicola Irwin
- Sponsor type
- University, hospital or other
- Collaborators
- Kirby Institute, The University of New South Wales
- Responsible party
- Sponsor-investigator, Nicola Irwin, The Canberra Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07164430
- Sponsor's protocol ID
- 2025.LRE.00223
- Status last verified
- Mar 2026
- First submitted
- 4 Sep 2025
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified IPD that underlie any published results may be shared upon reasonable request, and subject to ethics and governance processes.
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07164430
- Acronym / sponsor ID
- 2025.LRE.00223
- Conditions
- Respiratory Syncytial Virus (RSV) Infection, Respiratory Syncytial Virus Hospitalizations, Respiratory Syncytial Virus Immunization
- Keywords
- Interrupted Time Series Analysis, Epidemiologic Methods
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,792 participants (actual)
- Lead sponsor
- Nicola IrwinUniversity, hospital or other
- Collaborators
- Kirby Institute, The University of New South Wales
- Study start
- 22 Sep 2025 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 10 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RSV cases | – | –Children aged under 2 years with laboratory confirmed RSV infection |
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study is set in the Australian Capital Territory, a small Australian jurisdiction with a single acute paediatric service provider.
Key inclusion criteria (2 listed)
- child aged under 2 years
- laboratory confirmed RSV
Key exclusion criteria (1 listed)
- n/a
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Emergency Department presentations
Time frame: Monthly time intervals over a period of 3 years and 8 months
RSV cases
Time frame: At monthly intervals over 3 years and 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: Yes. Deidentified IPD that underlie any published results may be shared upon reasonable request, and subject to ethics and governance processes.
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Respiratory Syncytial Virus Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Syncytial Virus (RSV) Infection and Respiratory Syncytial Virus Hospitalizations, run by Nicola Irwin at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RSV Hospitalisation (time frame: At monthly time intervals over 3 years and 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.