Passive RSV antibody to protect Aboriginal and Torres Strait Islander infants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pragmatic, randomized trial in the Northern Territory compares a single intramuscular dose of nirsevimab with standard care in Aboriginal and Torres Strait Islander infants aged roughly 6 to 9 months. The study is designed to reflect real-world practice, with minimal additional procedures beyond usual care and a brief early safety check after enrollment. Outcomes are gathered mainly from routine health data and public health notifications to see if RSV infections are reduced over 12 months. Randomization is stratified by region, remoteness, and prior nirsevimab exposure. The study aims to determine if the antibody can provide protective benefit in the first and second year of life under everyday conditions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Aboriginal and/or Torres Strait Islander infant ≥ 6 calendar months old and \< 9 calendar months old.
2. Parent/caregiver is willing for their infant to participate in the study and informed consent for the infant's participation in the study has been given.
3. Parent/caregiver is willing to comply with all study procedures outlined in the protocol, including review of maternal/ infant immunisation records, electronic medical records and public health notifications, for the duration of the study.

Exclusion Criteria:

1. Infants with a contra-indication to RSV-SMA per the Australian Immunisation Handbook (i.e. anaphylaxis to a prior dose).
2. Infants who have received a prior dose of RSV-SMA at ≥ 3 calendar months old.
3. Previously enrolled in this trial.

Temporary Exclusion Criteria

1. Infants who have received a prior dose of RSV-SMA between ≥ 1 calendar months old and \< 3 calendar months old will be excluded until at least 150 days have passed since their most recent dose. Randomisation can be delayed until participants meet this criterion.
2. Acute illness at the time of assessment (e.g. fever ≥ 38.5°C, acute respiratory or other infection as determined by trained and delegated study staff) is temporarily excluded until they are recovered and/or symptom-free for ≥ 24 hours.

Where it's running

• Menzies School of Health Research
  Darwin, Northern Territory, Australia Recruiting

Study contacts

• Study coordinator: Bianca Middleton
• Email: bianca.middleton@menzies.edu.au
• Phone: +61 (0)402 093 321

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.