Respiratory Syncytial Virus (RSV)Phase 4THRIVENCT07578298
THRIVE - Trial of Passive Humoral RSV Immunity for Value and Effectiveness
A Phase 4 study testing Nirsevimab (RSV-specific monoclonal antibody) in people with Respiratory Syncytial Virus (RSV) and Respiratory Infection Virus, run by Menzies School of Health Research at 1 site in Australia.
Trial summary
RSV is a leading cause of severe respiratory illness and hospitalisation for young children, with particularly high rates of RSV respiratory infection observed amongst Aboriginal and Torres Strait Islander children living in Australia's Northern Territory. Read more about this study
- Who is it for?
- Ages 6 to 9 monthsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus (RSV), Respiratory Infection Virus
- What is being tested?
- Nirsevimab (RSV-specific monoclonal antibody)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteAustralia
- Study dates
- 17 Jun 2026to 31 Dec 2030
- Phase
- Phase 4
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 6 to 9 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Aboriginal and/or Torres Strait Islander infant ≥ 6 calendar months old and < 9 calendar months old.
- 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.
- 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.
Who cannot join
- Infants with a contra-indication to RSV-SMA per the Australian Immunisation Handbook (i.e. anaphylaxis to a prior dose).
- Infants who have received a prior dose of RSV-SMA at ≥ 3 calendar months old.
- Previously enrolled in this trial.
- Temporary Exclusion Criteria
- 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.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Menzies School of Health Research
Darwin, Northern Territory, 0810
Bianca F Middleton, MBBS (Hons), FRACP, MPH, PhD, +61 402 093 321, bianca.middleton@menzies.edu.au
About this study
Official title: Passive Immunisation With RSV-specific Monoclonal Antibody (RSV-SMA) to Prevent RSV Respiratory Infections Among Aboriginal and Torres Strait Islander Children in the Northern Territory: a Pragmatic Randomised Controlled Trial.
RSV is a leading cause of severe respiratory illness and hospitalisation for young children, with particularly high rates of RSV respiratory infection observed amongst Aboriginal and Torres Strait Islander children living in Australia's Northern Territory. The goal of this clinical trial is to evaluate whether routinely administering a single dose of respiratory syncytial virus (RSV)-specific monoclonal antibody, nirsevimab, from 6 months old, provides protection against RSV infections for Aboriginal and Torres Strait Islander children throughout in the first and second year of life.
In this study, participants will be randomly assigned to receive either a single dose of intra-muscular RSV-specific monoclonal antibody, nirsevimab, or standard care (no RSV-specific monoclonal antibody). The primary objective is to determine whether administration ofRSV-specific monoclonal antibody, nirsevimab reduces the occurrence of RSV infection over the subsequent 12 months. Secondary objectives include assessing whether nirsevimab reduces RSV-related hospital attendances, as well as respiratory and all-cause hospitalisations, over the following 6 and 12 months. An assessment of cost-effectiveness will also be undertaken.
Participants will receive the study intervention at 6 months of age (+90 days). Follow-up will be conducted through passive surveillance using electronic medical records and public health notification systems to capture relevant health outcomes.
Read the detailed description
This study is a pragmatic, parallel-group, randomised controlled trial conducted in the Northern Territory to evaluate an RSV prevention strategy in Aboriginal and Torres Strait Islander infants under real-world conditions.
Eligible infants aged approximately 6 months (+90 days) will be randomised in a 1:1 ratio to receive either a single intramuscular dose of RSV-specific monoclonal antibody (nirsevimab) or standard care. Randomisation will be stratified by geographic region (e.g. Top End and Central Australia), remoteness classification and prior nirsevimab dose status.
At enrolment, baseline data is collected to confirm eligibility and characterise the study population. This includes review of immunisation and birth records and collection of simple clinical measurements such as weight and temperature, consistent with routine care.
The study is designed to minimise participant burden and reflect routine clinical practice. Apart from the study intervention and a brief follow-up contact approximately 7 days after enrolment to assess early safety, no additional procedures or scheduled study visits are required. Participants will otherwise continue to receive standard healthcare through existing services.
Outcome ascertainment will be undertaken using passive follow-up through routinely collected health data. This includes review of hospital medical records and linkage with RSV notifications reported through the Northern Territory notifiable disease surveillance system. These data sources will be used to identify laboratory-confirmed RSV infection, healthcare presentations, and hospital admissions during the follow-up period.
The study incorporates a Bayesian adaptive design, allowing for interim analyses at predefined enrolment milestones. This enables potential early stopping for superiority or futility, ensuring efficient use of resources and minimising unnecessary exposure of participants.
An economic evaluation will be conducted alongside the trial to assess the cost-effectiveness of the intervention using observed healthcare utilisation and outcome data.
- Being tested
- Nirsevimab (RSV-specific monoclonal antibody)
- Keywords
- Respiratory Syncytial Virus (RSV), bayesian adaptive, pragmatic clinical trial, Aboriginal and Torres Strait Islander, infants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nirsevimab (RSV-specific monoclonal antibody)Biological
A single intramuscular dose of RSV-specific monoclonal antibody (RSV-SMA) - nirsevimab, will be administered from 6 months old (+ 90 days) to prevent RSV respiratory infections among Aboriginal and Torres Strait Islander children in the first and second year of life. Our randomised clinical trial will be among the first to evaluate the health and economic impact of routinely administering a dose of RSV-SMA from 6 months old in a year-round program for this high-risk population with less distinct RSV infection seasons.
| Study group | Role | What they receive |
|---|---|---|
| Nirsevimab (RSV-specific monoclonal antibody) | Experimental | Participants in the experimental arm will receive a single dose of RSV-specific monoclonal antibody - nirsevimab, administered from 6 months old (+ 90 days) in accordance with the licensed indication for RSV prevention. Dosing will be weight-based (50mg for infants < 5kg, and 100mg for infants ≥5 kg) and administered by unblinded study staff. Participants will continue to receive routine health care and additional immunisations in accordance with the National Immunisation Program and local guidelines. Receives: Biological: Nirsevimab (RSV-specific monoclonal antibody) |
| Standard Care | No intervention | Participants in the standard care arm will NOT receive a dose of RSV-specific monoclonal antibody - nirsevimab. Participants will continue to receive routine health care and immunisations in accordance with the National Immunisation Program and local guidelines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
RSV infection
RSV respiratory infection detected by reverse transcription polymerase chain reaction (RT-PCR) on a respiratory specimen from time of randomisation to before 6-months and before 12-months post-randomisation AND notified to the NT Notifiable Disease System. RSV infection before 12 months post-randomisation is the primary endpoint.
Measured: Before 6-months and 12-months post randomisation date
Secondary outcomes (5)
RSV hospital attendance
Any emergency department presentation or hospital admission at any time from time of randomisation to before 6-months and before 12- months post-randomisation, AND for which RSV is detected by RT-PCR of a respiratory specimen (regardless of notification) collected at any time from 120 hours before hospital presentation to 72 hours afterwards.
Measured: Before 6-months and 12-months post randomisation date
RSV hospitalisation
Subset of RSV hospital attendances resulting in admission to an inpatient service.
Measured: Before 6-months and 12-months post randomisation date
RSV hospitalisation - severe
Subset of RSV hospitalisations WITH any documented oxygen saturation <90% at any point during the clinical presentation in accordance with the World Health Organization case definition, AND WITH documented receipt of supplemental oxygen.
Measured: Before 6-months and 12-months post randomisation date.
Respiratory hospitalisation
Any admission to an inpatient service from time of randomisation to before 6 -months and before 12-months post randomisation AND receiving a primary diagnosis consistent with any acute respiratory infection, including bronchiolitis, bronchitis, pneumonia, influenza, whooping cough, or chest/respiratory infection, OR RSV hospitalisation.
Measured: Before 6-months and 12-months post randomisation date
Any hospitalisation
Hospital admission to an inpatient service at any time after time of randomisation to before 6-month and before 12-months post randomisation regardless of primary diagnosis.
Measured: Before 6-months and 12-months post randomisation date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study start17 Jun 2026
- Primary completion31 Jul 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
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)Studies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- pragmatic phase IV, observer-blinded, randomised controlled trial using bayesian adaptive statistical methods
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menzies School of Health Research
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sydney, Murdoch Childrens Research Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07578298
- Sponsor's protocol ID
- GNT2043738
- Acronym
- THRIVE
- Status last verified
- Oct 2026
- First submitted
- 5 May 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified individual data may be shared following consultation with the Australian First Nations Reference Group for Maternal and Child Health, First Nations researchers and Cultural Advisors, and in compliance with Indigenous Data Sovereignty principles.