[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641007":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":24,"locations":34,"responsibleParty":51,"collaborators":53,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":66,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":18,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":80,"overallStatus":85,"whyStopped":18,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Menzies School of Health Research","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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 \\\u003C 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.",[13],"Biological: Nirsevimab (RSV-specific monoclonal antibody)",{"label":15,"type":16,"description":17,"interventionNames":18},"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.",null,[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":18},"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.",[9],[25,30],{"name":26,"role":27,"phone":28,"phoneExt":18,"email":29},"Bianca Middleton","CONTACT","+61 (0)402 093 321","bianca.middleton@menzies.edu.au",{"name":31,"role":27,"phone":32,"phoneExt":18,"email":33},"Sarah Gallagher","+61 (0)416 060 674","sarah.gallagher@menzies.edu.au",[35],{"facility":5,"status":18,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Darwin","Northern Territory","0810","Australia","AU",{"type":42,"coordinates":43},"Point",[44,45],130.84185,-12.46113,{"lat":45,"lon":44},[48],{"name":49,"role":27,"phone":50,"phoneExt":18,"email":29},"Bianca F Middleton, MBBS (Hons), FRACP, MPH, PhD","+61 402 093 321",{"type":52,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[54,56],{"name":55,"class":6},"University of Sydney",{"name":57,"class":6},"Murdoch Childrens Research Institute","100641007","phase-4-thrive---trial-of-passive-humoral-rsv-immunity-for-value-and-effectiveness-100641007",false,"NCT07578298","THRIVE - Trial of Passive Humoral RSV Immunity for Value and Effectiveness","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.","THRIVE","Inclusion Criteria:\n\n1. Aboriginal and\u002For Torres Strait Islander infant ≥ 6 calendar months old and \\\u003C 9 calendar months old.\n2. Parent\u002Fcaregiver is willing for their infant to participate in the study and informed consent for the infant's participation in the study has been given.\n3. Parent\u002Fcaregiver is willing to comply with all study procedures outlined in the protocol, including review of maternal\u002F infant immunisation records, electronic medical records and public health notifications, for the duration of the study.\n\nExclusion Criteria:\n\n1. Infants with a contra-indication to RSV-SMA per the Australian Immunisation Handbook (i.e. anaphylaxis to a prior dose).\n2. Infants who have received a prior dose of RSV-SMA at ≥ 3 calendar months old.\n3. Previously enrolled in this trial.\n\nTemporary Exclusion Criteria\n\n1. Infants who have received a prior dose of RSV-SMA between ≥ 1 calendar months old and \\\u003C 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.\n2. 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\u002For symptom-free for ≥ 24 hours.",true,"ALL","6 Months","9 Months",{"count":71,"type":72},1000,"ESTIMATED","INTERVENTIONAL",[75],"PHASE4","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.\n\nIn 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.\n\nParticipants 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.",[78,79],"Respiratory Syncytial Virus (RSV)","Respiratory Infection Virus",[78,81,82,83,84],"bayesian adaptive","pragmatic clinical trial","Aboriginal and Torres Strait Islander","infants","NOT_YET_RECRUITING","2026-05-05",{"date":88,"type":89},"2026-05-11","ACTUAL",{"date":91,"type":72},"2026-05-15",{"date":93,"type":72},"2030-12-31",{"name":5,"class":6},1]