[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100066781":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":31,"locations":36,"responsibleParty":124,"collaborators":31,"id":126,"slug":127,"hasResults":128,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":31,"eligibilityCriteria":132,"healthyVolunteers":128,"sex":133,"minAge":134,"maxAge":135,"enrollmentInfo":136,"targetDuration":31,"studyType":139,"phases":140,"briefSummary":142,"conditions":143,"keywords":145,"overallStatus":147,"whyStopped":31,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":156},{"fullName":5,"class":6},"MedImmune LLC","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo","PLACEBO_COMPARATOR","Participants will receive IM dose of placebo matched to motavizumab every 30 days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the the RSV season.",[13],"Other: Placebo",{"label":15,"type":16,"description":17,"interventionNames":18},"Motavizumab","ACTIVE_COMPARATOR","Participants will receive IM dose of motavizumab 15 milligram\u002FKilogram (mg\u002Fkg) every 30 Days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the RSV season.",[19],"Biological: Motavizumab",[21,27],{"type":22,"name":15,"description":23,"armGroupLabels":24,"otherNames":25},"BIOLOGICAL","Intramuscular dose of motavizumab 15 mg\u002Fkg will be administered every 30 Days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the RSV season.",[15],[26],"MEDI-524",{"type":28,"name":9,"description":29,"armGroupLabels":30,"otherNames":31},"OTHER","Intramuscular dose of placebo matched to motavizumab will be administered every 30 days for a maximum of 5 injections (on Days 0, 30, 60, 90, and 120) during the the RSV season.",[9],null,[33],{"name":34,"affiliation":5,"role":35},"MedImmune, LLC MedImmune, LLC","STUDY_DIRECTOR",[37,49,56,58,65,72,79,86,95,103,110,117],{"facility":38,"status":31,"city":39,"state":40,"zip":31,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":31},"Research Site","Chinle","Arizona","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-109.55261,36.15445,{"lat":47,"lon":46},{"facility":38,"status":31,"city":50,"state":40,"zip":31,"country":41,"countryCode":42,"cosmosGeoPoint":51,"geoPoint":55,"contacts":31},"Cibecue",{"type":44,"coordinates":52},[53,54],-110.48539,34.04477,{"lat":54,"lon":53},{"facility":38,"status":31,"city":57,"state":40,"zip":31,"country":41,"countryCode":42,"cosmosGeoPoint":31,"geoPoint":31,"contacts":31},"Fort Definace",{"facility":38,"status":31,"city":59,"state":40,"zip":31,"country":41,"countryCode":42,"cosmosGeoPoint":60,"geoPoint":64,"contacts":31},"San 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City",{"type":44,"coordinates":68},[69,70],-111.23986,36.13499,{"lat":70,"lon":69},{"facility":38,"status":31,"city":73,"state":40,"zip":31,"country":41,"countryCode":42,"cosmosGeoPoint":74,"geoPoint":78,"contacts":31},"Whiteriver",{"type":44,"coordinates":75},[76,77],-109.96427,33.83699,{"lat":77,"lon":76},{"facility":38,"status":31,"city":80,"state":40,"zip":31,"country":41,"countryCode":42,"cosmosGeoPoint":81,"geoPoint":85,"contacts":31},"Winslow",{"type":44,"coordinates":82},[83,84],-110.69736,35.02419,{"lat":84,"lon":83},{"facility":38,"status":31,"city":87,"state":88,"zip":89,"country":41,"countryCode":42,"cosmosGeoPoint":90,"geoPoint":94,"contacts":31},"Baltimore","Maryland","21205",{"type":44,"coordinates":91},[92,93],-76.61219,39.29038,{"lat":93,"lon":92},{"facility":38,"status":31,"city":96,"state":97,"zip":31,"country":41,"countryCode":42,"cosmosGeoPoint":98,"geoPoint":102,"contacts":31},"Bloomfield","New Mexico",{"type":44,"coordinates":99},[100,101],-107.98451,36.71112,{"lat":101,"lon":100},{"facility":38,"status":31,"city":104,"state":97,"zip":31,"country":41,"countryCode":42,"cosmosGeoPoint":105,"geoPoint":109,"contacts":31},"Crownpoint",{"type":44,"coordinates":106},[107,108],-108.15118,35.67808,{"lat":108,"lon":107},{"facility":38,"status":31,"city":111,"state":97,"zip":31,"country":41,"countryCode":42,"cosmosGeoPoint":112,"geoPoint":116,"contacts":31},"Gallup",{"type":44,"coordinates":113},[114,115],-108.74258,35.52808,{"lat":115,"lon":114},{"facility":38,"status":31,"city":118,"state":97,"zip":31,"country":41,"countryCode":42,"cosmosGeoPoint":119,"geoPoint":123,"contacts":31},"Shiprock",{"type":44,"coordinates":120},[121,122],-108.68703,36.78555,{"lat":122,"lon":121},{"type":125,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100066781","phase-3-medi-524-motavizumab-for-the-prevention-of-respiratory-sycytial-virus-rsv-disease-among-native-american-indian-infants-in-the-southwestern-united-states-100066781",true,"NCT00121108","MEDI-524 (Motavizumab) for the Prevention of Respiratory Sycytial Virus (RSV) Disease Among Native American Indian Infants in the Southwestern United States","A Phase 3 Study of MEDI-524 (Motavizumab), an Enhanced Potency Humanized Respiratory Syncytial Virus (RSV) Monoclonal Antibody, for the Prevention of RSV Disease Among Native American Infants in the Southwestern United States","Inclusion Criteria:\n\n* 6 months of age or younger at randomization (child must be randomized on or before their 6-month birthday)\n* Male or female Native American\n* General state of good health\n* Written informed consent obtained from the participant's parent(s) or legal guardian\n\nExclusion Criteria:\n\n* Gestational age less than or equal to 35 weeks\n* Chronic lung disease of prematurity\n* A bleeding diathesis that would preclude IM injections\n* Hospitalization at the time of randomization (unless discharge is anticipated within 10 days)\n* Active RSV infection (a child with signs\u002Fsymptoms of respiratory infection must have negative RSV testing) or known prior history of RSV infection\n* A documented wheezing episode before enrollment\n* Known renal impairment\n* Known hepatic dysfunction\n* Clinically significant congenital anomaly of the respiratory tract\n* Chronic seizure or evolving or unstable neurologic disorder\n* Congenital heart disease (CHD) (children with uncomplicated CHD \\[e.g., Patent ductus arteriosus, small septal defect\\] and children with complicated CHD who are currently anatomically and hemodynamically)\n* Known immunodeficiency\n* Mother with human immunodeficiency virus infection (unless the child has been proven to be not infected)\n* Known allergy to Ig products\n* Receipt of palivizumab, Respiratory syncytial virus immunoglobulin, intravenous (RSV-IGIV), or other RSV-specific monoclonal antibody, or any other polyclonal antibody (for example, hepatitis B immunoglobulin, IVIG) within 3 months prior to randomization\n* Anticipated use of palivizumab or IVIG during the study (blood transfusions permitted)\n* Previous receipt of RSV vaccines\n* Participation in other investigational drug product studies\n* Any medical or social condition which, in the opinion of the investigator, would adversely affect monitoring the infant\n* Inability to complete the study follow-up period through up to 5 years of age","ALL","0 Months","6 Months",{"count":137,"type":138},2127,"ACTUAL","INTERVENTIONAL",[141],"PHASE3","MI-CP117 was a Phase 3, randomized, double-blind, placebo-controlled trial designed to determine if motavizumab is more effective than placebo in reducing RSV hospitalization in otherwise healthy Native American Infants in the Southwestern United States during their first RSV season.",[144],"Healthy",[146],"RSV, infants, Native American Indians","COMPLETED","2021-12-07",{"date":150,"type":138},"2022-01-05",{"date":152,"type":138},"2004-11-15",{"date":154,"type":138},"2010-12-27",{"name":5,"class":6},12]