Respiratory Syncytial Viral (RSV) InfectionsNCT06993753
Duration of Protection of Nirsevimab Against Hospitalisation for Respiratory Syncytial Virus Infection
An observational study of Respiratory Syncytial Viral (RSV) Infections, run by Griffith University at 1 site in Australia.
Trial summary
Respiratory syncytial virus (RSV) is a leading cause of hospitalizations for acute lower respiratory tract infection (LRTI) in infants. In Australia approximately 1.5% of infants are hospitalized due to RSV, 80% of whom are born full-term and are otherwise healthy. Read more about this study
- Who is it for?
- Ages Up to 1 year
- Conditions the study is for
- Respiratory Syncytial Viral (RSV) Infections
- How many people
- 4,350 participants
- Where
- 1 siteAustralia
- Study dates
- 15 Apr 2024to 31 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 1 year
- All sexes
- No healthy volunteers
- Child
Study population: Our study population will consist of all infants born in Queensland between 15 April 2024 and 30 April 2025 and hospitaliszed for any reason between 15 April 2024 and 30 April 2026. Cases will be All infants born in Queensland between 15 April 2024 and 30 April 2025 who were admitted to any hospital in Queensland (public and private) between 15 April 2024 and 30 April 2026 with a respiratory related principle or other diagnosis (ICD codes J21.0, J20.5, J12.1, B97.4). Controls will be defined as infants admitted to the same hospital that do not have a diagnosis of (ICD codes J21.0, J20.5, J12.1, B97.4) and that the admission is not an elective admission. For each included case, five controls (where possible) matched on month of birth and sex will be requested to enable appropriate comparison.
Inclusion Criteria: Any infant born between 15 April 2024 and 30 April 2025 and hospitalized for any reason between 15 April 2024 and 30 April 2026.
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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Queensland Infant Birth Dose RSV Immunisation Program 2024 - Duration of Protection and Impact
Respiratory syncytial virus (RSV) is a leading cause of hospitalizations for acute lower respiratory tract infection (LRTI) in infants. In Australia approximately 1.5% of infants are hospitalized due to RSV, 80% of whom are born full-term and are otherwise healthy. Two randomized trials have used a seasonal implementation strategy to show nirsevimab, a long-acting monoclonal antibody, has sustained efficacy against RSV LRTI hospitalizations in the first 150-180 days after administration. Nirsevimab has been approved in many countries for the prevention of RSV-LRTI in neonates and infants. However, the protection offered by nirsevimab beyond 180 days remains unknown. Queensland is a large Australian state spanning the tropical and sub-tropical climate zones, where RSV circulates year-round. The Queensland government publicly funded nirsevimab for all infants at birth from 15 April 2024. The aim of this study is to estimate the duration of effectiveness of nirsevimab against RSV-related hospitalizations.
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.
Read more
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.
- Keywords
- Respiratory syncytial virus, Case control, monoclonal antibody, nirsevimab
- 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 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. | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The duration of effectiveness of nirsevimab against RSV-related hospitalizations.
Measured: From mid April 2024 to mid April 2026
Secondary outcomes (4)
Estimate the quantities of the laboratory confirmed RSV hospitalization length of stay and paediatric intensive care unit admission that were prevented by a 12-month year-round nirsevimab immunization program in Queensland infants.
Measured: From mid April 2024 to mid April 2026
Estimate the quantities of all cause acute respiratory hospitalization and PICU admissions that were prevented by nirsevimab immunization program in Queensland infants
Measured: From mid April 2024 to mid April 2026
Estimate the quantities of all death from RSV-related illness that were prevented by a 12-month year-round nirsevimab immunization program in Queensland infants
Measured: From mid April 2024 to mid April 2026
Evaluate the impact of nirsevimab on the cost of hospital services in Queensland, Australia
Measured: From mid April 2024 to mid April 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start15 Apr 2024
- Primary completion15 Apr 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial Viral (RSV) InfectionsStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 4,350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Griffith University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa El-Heneidy, Griffith University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06993753
- Sponsor's protocol ID
- 2024/851
- Other IDs
- VAS00012
- Status last verified
- Feb 2025
- First submitted
- 19 May 2025
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Queensland Infant Birth Dose RSV Immunisation Program 2024 - Duration of Protection and Impact
- ClinicalTrials.gov ID
- NCT06993753
- Acronym / sponsor ID
- 2024/851
- Keywords
- Respiratory syncytial virus, Case control, monoclonal antibody, nirsevimab
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 4,350 participants (estimated)
- Lead sponsor
- Griffith UniversityUniversity, hospital or other
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 15 Apr 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 29 May 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.
Respiratory syncytial virus (RSV) is a leading cause of hospitalizations for acute lower respiratory tract infection (LRTI) in infants. In Australia approximately 1.5% of infants are hospitalized due to RSV, 80% of whom are born full-term and are otherwise healthy. Two randomized trials have used a seasonal implementation strategy to show nirsevimab, a long-acting monoclonal antibody, has sustained efficacy against RSV LRTI hospitalizations in the first 150-180 days after administration. Nirsevimab has been approved in many countries for the prevention of RSV-LRTI in neonates and infants. However, the protection offered by nirsevimab beyond 180 days remains unknown. Queensland is a large Australian state spanning the tropical and sub-tropical climate zones, where RSV circulates year-round. The Queensland government publicly funded nirsevimab for all infants at birth from 15 April 2024. The aim of this study is to estimate the duration of effectiveness of nirsevimab against RSV-related hospitalizations.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
| 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. |
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Our study population will consist of all infants born in Queensland between 15 April 2024 and 30 April 2025 and hospitaliszed for any reason between 15 April 2024 and 30 April 2026. Cases will be All infants born in Queensland between 15 April 2024 and 30 April 2025 who were admitted to any hospital in Queensland (public and private) between 15 April 2024 and 30 April 2026 with a respiratory related principle or other diagnosis (ICD codes J21.0, J20.5, J12.1, B97.4). Controls will be defined as infants admitted to the same hospital that do not have a diagnosis of (ICD codes J21.0, J20.5, J12.1, B97.4) and that the admission is not an elective admission. For each included case, five controls (where possible) matched on month of birth and sex will be requested to enable appropriate comparison.
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
The duration of effectiveness of nirsevimab against RSV-related hospitalizations.
Time frame: From mid April 2024 to mid April 2026
4 secondary outcomes
Estimate the quantities of the laboratory confirmed RSV hospitalization length of stay and paediatric intensive care unit admission that were prevented by a 12-month year-round nirsevimab immunization program in Queensland infants.
Time frame: From mid April 2024 to mid April 2026
Estimate the quantities of all cause acute respiratory hospitalization and PICU admissions that were prevented by nirsevimab immunization program in Queensland infants
Time frame: From mid April 2024 to mid April 2026
Estimate the quantities of all death from RSV-related illness that were prevented by a 12-month year-round nirsevimab immunization program in Queensland infants
Time frame: From mid April 2024 to mid April 2026
Evaluate the impact of nirsevimab on the cost of hospital services in Queensland, Australia
Time frame: From mid April 2024 to mid April 2026
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Individual participant dataSharing planned: Undecided
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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 Viral (RSV) Infections, run by Griffith University 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?
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: under way, not looking for participants, as of the sponsor's last update on 29 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
The duration of effectiveness of nirsevimab against RSV-related hospitalizations. (time frame: From mid April 2024 to mid April 2026). 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 29 May 2025.