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

RecruitingPhase 4Ages 6 Months - 9 MonthsAllMenzies School of Health Research
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In plain words

What the trial is, and whether it could suit you

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, nirse

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📋 Eligibility rules (as published)
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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What it tests

  • Nirsevimab (RSV-specific monoclonal antibody)
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Where

1 site
Menzies School of Health Research
Darwin, Australia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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