THRIVE - Trial of Passive Humoral RSV Immunity for Value and Effectiveness

NCT07578298 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: GNT2043738
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Respiratory Syncytial Virus (RSV); Respiratory Infection Virus

Keywords

Respiratory Syncytial Virus (RSV); bayesian adaptive; pragmatic clinical trial; Aboriginal and Torres Strait Islander; infants

Outcome Measures

Primary Outcomes (1)

• 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.

  Before 6-months and 12-months post randomisation date

Secondary Outcomes (5)

• RSV hospital attendance

  Before 6-months and 12-months post randomisation date

• RSV hospitalisation

  Before 6-months and 12-months post randomisation date

• RSV hospitalisation - severe

  Before 6-months and 12-months post randomisation date.

• Respiratory hospitalisation

  Before 6-months and 12-months post randomisation date

• Any hospitalisation

  Before 6-months and 12-months post randomisation date

Study Arms (2)

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.

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.

Interventions

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.

Nirsevimab (RSV-specific monoclonal antibody)

Eligibility Criteria

• Age: 6 Months - 9 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Menzies School of Health Research: lead
• University of Sydney: collaborator
• Murdoch Childrens Research Institute: collaborator

Study Sites (1)

Menzies School of Health Research

Darwin, Northern Territory, 0810, Australia

Location

MeSH Terms

Interventions

nirsevimab

Central Study Contacts

Bianca Middleton

CONTACT

+61 (0)402 093 321; bianca.middleton@menzies.edu.au

Sarah Gallagher

CONTACT

+61 (0)416 060 674; sarah.gallagher@menzies.edu.au

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: pragmatic phase IV, observer-blinded, randomised controlled trial using bayesian adaptive statistical methods

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 11, 2026
• Study Start: May 15, 2026
• Primary Completion (Estimated): July 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: May 11, 2026

Record last verified: 2026-01

Locations

AU (1)