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One shot to stop RSV: landmark trial for indigenous kids

NCT ID NCT07578298

Prevention Sponsor: Menzies School of Health Research Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a single dose of nirsevimab, an antibody that targets RSV, can prevent respiratory infections in Aboriginal and Torres Strait Islander children aged 6 months. Around 1,000 children will be randomly assigned to receive either the antibody or standard care. The goal is to see if the shot reduces RSV infections and hospital visits over the next year.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
nirsevimab (a monoclonal antibody)
What this could lead to
If successful, this could provide a safe and effective way to prevent severe RSV infections in high-risk young children, reducing hospitalisations and health costs.
What could go wrong
This is a single-dose study in a specific population, and results may not apply broadly. The trial is not yet recruiting, and the antibody's long-term effectiveness beyond 12 months is unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 1,000 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 to 9 months

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

viral respiratory tract infection respiratory syncytial virus infectious disease prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Respiratory infection virus Respiratory syncytial virus (RSV)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Menzies School of Health Research

    Darwin, Northern Territory, 0810, Australia

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