RECRUITING Phase 4 ClinicalTrials.gov

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

Sponsor: Menzies School of Health Research • ClinicalTrials.gov ID: NCT07578298

Registry updated: 2026-10-07

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Description

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.

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.

Eligibility criteria

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.

Conditions

Respiratory Syncytial Virus (RSV) Respiratory Infection Virus

Locations

Menzies School of Health Research — Darwin, Northern Territory, Australia

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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