[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100072146":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":20,"locations":25,"responsibleParty":20,"collaborators":20,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":20,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":20,"studyType":67,"phases":68,"briefSummary":71,"conditions":72,"keywords":20,"overallStatus":74,"whyStopped":20,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"MedImmune LLC","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"1","ACTIVE_COMPARATOR","MEDI-524",[13],"Biological: Medi-524",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","Medi-524","IM doses of MEDI-524 administered at 3 mg\u002Fkg or 15 mg\u002Fkg at 30 day intervals",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Genevieve Losonsky, MD","STUDY_DIRECTOR",[26,38,44],{"facility":27,"status":20,"city":28,"state":20,"zip":29,"country":30,"countryCode":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":20},"Hospital General de Niños \"Ricardo Gutierrez\"","Buenos Aires","1330","Argentina","AR",{"type":33,"coordinates":34},"Point",[35,36],-58.37723,-34.61315,{"lat":36,"lon":35},{"facility":39,"status":20,"city":28,"state":20,"zip":40,"country":30,"countryCode":31,"cosmosGeoPoint":41,"geoPoint":43,"contacts":20},"Hospital Interzonal General de Agudos \"Dr. Diego Paroissien","5975",{"type":33,"coordinates":42},[35,36],{"lat":36,"lon":35},{"facility":45,"status":20,"city":46,"state":20,"zip":20,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":53,"contacts":20},"Hospital Clinico Pontificia Universidad Catolica de Chile","Santiago","Chile","CL",{"type":33,"coordinates":50},[51,52],-70.64827,-33.45694,{"lat":52,"lon":51},"100072146","phase-1-open-label-dose-escalation-study-of-2-to-5-im-doses-of-medi-524-at-3-mgkg-or-15-mgkg-children-to-be-followed-for-90-days-after-their-last-dose-of-medi-524-100072146",false,"NCT00192478","Open-Label, Dose-Escalation Study of 2 to 5 IM Doses of MEDI-524 at 3 mg\u002Fkg or 15 mg\u002Fkg; Children to be Followed for 90 Days After Their Last Dose of MEDI-524","A Phase 1\u002F2, Open-Label, Repeat-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of MEDI-524, a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus (RSV), in Children at Risk for Serious RSV Disease","Inclusion Criteria:\n\n* All male or female children must have met all the following criteria:\n* \\[Groups 1, 2, and 3\\] The child must have been born at ³32 to £35 weeks gestation and have been £6 months of age at the time of entry into the study (child must have been entered on or before their 6-month birthday) or \\[Group 3 only\\] The child must have been £24 months of age at the time of entry into the study (child must have been entered on or before their 24-month birthday) and diagnosed with BPD, with stable or decreasing doses of diuretics, steroids, or bronchodilators within the previous 6 months\n* The child must have been in general good health at the time of entry\n* The child's parent or legal guardian must have provided written informed consent; and\n* The child must have been able to complete the follow-up visits through 90 days following last injection of MEDI-524\n* Parent\u002Flegal guardian of patient must have had available telephone access\n\nExclusion Criteria:\n\n* Children must have had none of the following:\n* Hospitalization at the time of study entry (unless discharge was expected within 3 days after entry into the study)\n* \\[All children in Groups 1 and 2; only children £6 months of age in Group 3\\] Birth hospitalization \\>6 weeks duration or \\[Only children \\>6 months of age in Group 3\\] Birth hospitalization \\>12 weeks duration\n* Been receiving chronic oxygen therapy or mechanical ventilation at the time of study entry (including CPAP)\n* \\[Groups 1 and 2 only\\] Diagnosis of BPD, defined as history of prematurity and associated chronic lung disease with oxygen requirement for \\>28 days\n* Congenital heart disease (CHD) (Children with medically or surgically corrected \\[closed\\] patent ductus arteriosus and no other CHD may be enrolled)\n* Evidence of infection with hepatitis A, B, or C virus\n* Known renal impairment, hepatic dysfunction, chronic seizure disorder, or immunodeficiency or HIV infection\n* Mother with known HIV infection\n* Any of the following laboratory findings in blood obtained within 7 days prior to study entry: BUN or creatinine \\>1.5´ the upper limit of normal for age; AST (SGOT) or ALT (SGPT) \\>1.5´ the upper limit of normal for age; hemoglobin \\\u003C9.5 gm\u002FdL; white blood cell count \\\u003C4,000 cells\u002Fmm3; platelet count \\\u003C120,000 cells\u002Fmm3\n* Acute illness or progressive clinical disorder\n* Active infection, including acute RSV infection\n* Previous reaction to IGIV, blood products, or other foreign proteins\n* Have ever received palivizumab\n* Received within the past 120 days or currently receiving immunoglobulin products (such as RSV-IGIV \\[RespiGamÒ\\], IVIG), or any investigational agents\n* Currently participating in any investigational study\n* Previously participated in any investigational study of RSV vaccines or monoclonal antibodies.","ALL","6 Months","24 Months",{"count":65,"type":66},217,"ACTUAL","INTERVENTIONAL",[69,70],"PHASE1","PHASE2","MEDI-524 given for up to 5 doses at 3 and 15 mg\u002Fkg to high-risk children appeared to be safe and well tolerated.",[73],"Respiratory Syncytial Virus Infections","COMPLETED","2008-07-24",{"date":77,"type":78},"2008-07-28","ESTIMATED",{"date":80,"type":20},"2004-02",{"date":82,"type":66},"2006-08",{"name":5,"class":6},3]