Trial Review

Please note that the ANZCTR will be unattended on Monday 9th June due to an Australian public holiday.

Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements.
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06993753




Registration number
NCT06993753
Ethics application status
Date submitted
19/05/2025
Date registered
29/05/2025
Date last updated
29/05/2025

Titles & IDs
Public title
Duration of Protection of Nirsevimab Against Hospitalisation for Respiratory Syncytial Virus Infection
Scientific title
Queensland Infant Birth Dose RSV Immunisation Program 2024 - Duration of Protection and Impact
Secondary ID [1] 0 0
VAS00012
Secondary ID [2] 0 0
2024/851
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Syncytial Viral (RSV) Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The duration of effectiveness of nirsevimab against RSV-related hospitalizations.
Timepoint [1] 0 0
From mid April 2024 to mid April 2026
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
From mid April 2024 to mid April 2026
Secondary outcome [2] 0 0
Estimate the quantities of all cause acute respiratory hospitalization and PICU admissions that were prevented by nirsevimab immunization program in Queensland infants
Timepoint [2] 0 0
From mid April 2024 to mid April 2026
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
From mid April 2024 to mid April 2026
Secondary outcome [4] 0 0
Evaluate the impact of nirsevimab on the cost of hospital services in Queensland, Australia
Timepoint [4] 0 0
From mid April 2024 to mid April 2026

Eligibility
Key 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.
Minimum age
No limit
Maximum age
1 Year
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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).

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/04/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/03/2027
Actual
Sample size
Target
4350
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Griffith University - Gold Coast
Recruitment postcode(s) [1] 0 0
4215 - Gold Coast

Funding & Sponsors
Primary sponsor type
Other
Name
Griffith University
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06993753