[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100318241":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":40,"centralContacts":39,"locations":44,"responsibleParty":182,"collaborators":39,"id":184,"slug":185,"hasResults":186,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":39,"eligibilityCriteria":190,"healthyVolunteers":186,"sex":191,"minAge":192,"maxAge":193,"enrollmentInfo":194,"targetDuration":39,"studyType":197,"phases":198,"briefSummary":200,"conditions":201,"keywords":203,"overallStatus":205,"whyStopped":39,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":214},{"fullName":5,"class":6},"Takeda","INDUSTRY",[8,14,20,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo","PLACEBO_COMPARATOR","TDV placebo matching injection, subcutaneously (SC) once on Day 1, and Day 90.",[13],"Biological: Placebo",{"label":15,"type":16,"description":17,"interventionNames":18},"TDV Lot 1","EXPERIMENTAL","Participants were administered TDV lot 1, 0.5 ml (each TDV 0.5 mL dose contained TDV-1, TDV-2, TDV-3, and TDV-4), SC injection, once on Day 1, and Day 90.",[19],"Biological: TAK-003",{"label":21,"type":16,"description":22,"interventionNames":23},"TDV Lot 2","Participants were administered TDV lot 2, 0.5 ml (each TDV 0.5 mL dose contained TDV-1, TDV-2, TDV-3, and TDV-4), SC injection, once on Day 1, and Day 90.",[19],{"label":25,"type":16,"description":26,"interventionNames":27},"TDV Lot 3","Participants were administered TDV lot 3, 0.5 ml (each TDV 0.5 mL dose contained TDV-1, TDV-2, TDV-3, and TDV-4), SC injection once on Day 1, and Day 90.",[19],[29,36],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"BIOLOGICAL","TAK-003","TDV subcutaneous injection",[15,21,25],[35],"TDV",{"type":30,"name":9,"description":37,"armGroupLabels":38,"otherNames":39},"TDV Placebo-matching normal saline (0.9% NaCl) subcutaneous injection",[9],null,[41],{"name":42,"affiliation":5,"role":43},"Medical Director Clinical Science","STUDY_DIRECTOR",[45,58,68,78,87,97,107,116,125,135,145,155,165,174],{"facility":46,"status":39,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":39},"Optimal Research","Huntsville","Alabama","35802","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-86.58594,34.7304,{"lat":56,"lon":55},{"facility":59,"status":39,"city":60,"state":61,"zip":62,"country":50,"countryCode":51,"cosmosGeoPoint":63,"geoPoint":67,"contacts":39},"Anaheim Clinical Trials, LLC","Anaheim","California","92805",{"type":53,"coordinates":64},[65,66],-117.9145,33.83529,{"lat":66,"lon":65},{"facility":69,"status":39,"city":70,"state":71,"zip":72,"country":50,"countryCode":51,"cosmosGeoPoint":73,"geoPoint":77,"contacts":39},"Advanced Clinical Research","Boise","Idaho","83704",{"type":53,"coordinates":74},[75,76],-116.20345,43.6135,{"lat":76,"lon":75},{"facility":46,"status":39,"city":79,"state":80,"zip":81,"country":50,"countryCode":51,"cosmosGeoPoint":82,"geoPoint":86,"contacts":39},"Peoria","Illinois","61614",{"type":53,"coordinates":83},[84,85],-89.58899,40.69365,{"lat":85,"lon":84},{"facility":88,"status":39,"city":89,"state":90,"zip":91,"country":50,"countryCode":51,"cosmosGeoPoint":92,"geoPoint":96,"contacts":39},"Synexus Limited- Council Bluffs","Council Bluffs","Iowa","51503",{"type":53,"coordinates":93},[94,95],-95.86083,41.26194,{"lat":95,"lon":94},{"facility":98,"status":39,"city":99,"state":100,"zip":101,"country":50,"countryCode":51,"cosmosGeoPoint":102,"geoPoint":106,"contacts":39},"Heartland Research Associates LLC - Augusta","Augusta","Kansas","67010",{"type":53,"coordinates":103},[104,105],-96.9767,37.68668,{"lat":105,"lon":104},{"facility":108,"status":39,"city":109,"state":100,"zip":110,"country":50,"countryCode":51,"cosmosGeoPoint":111,"geoPoint":115,"contacts":39},"Heartland Research Associates LLC","Park City","67219",{"type":53,"coordinates":112},[113,114],-97.31838,37.80001,{"lat":114,"lon":113},{"facility":46,"status":39,"city":117,"state":118,"zip":119,"country":50,"countryCode":51,"cosmosGeoPoint":120,"geoPoint":124,"contacts":39},"Rockville","Maryland","20850",{"type":53,"coordinates":121},[122,123],-77.15276,39.084,{"lat":123,"lon":122},{"facility":126,"status":39,"city":127,"state":128,"zip":129,"country":50,"countryCode":51,"cosmosGeoPoint":130,"geoPoint":134,"contacts":39},"Synexus Limited - Minneapolis","Edina","Minnesota","55435",{"type":53,"coordinates":131},[132,133],-93.34995,44.88969,{"lat":133,"lon":132},{"facility":136,"status":39,"city":137,"state":138,"zip":139,"country":50,"countryCode":51,"cosmosGeoPoint":140,"geoPoint":144,"contacts":39},"Synexus Limited - St. Louis","St Louis","Missouri","63141",{"type":53,"coordinates":141},[142,143],-90.19789,38.62727,{"lat":143,"lon":142},{"facility":146,"status":39,"city":147,"state":148,"zip":149,"country":50,"countryCode":51,"cosmosGeoPoint":150,"geoPoint":154,"contacts":39},"Clinical Research Center of Nevada","Las Vegas","Nevada","89104",{"type":53,"coordinates":151},[152,153],-115.13722,36.17497,{"lat":153,"lon":152},{"facility":156,"status":39,"city":157,"state":158,"zip":159,"country":50,"countryCode":51,"cosmosGeoPoint":160,"geoPoint":164,"contacts":39},"Synexus Limited - Columbus","Columbus","Ohio","43212",{"type":53,"coordinates":161},[162,163],-82.99879,39.96118,{"lat":163,"lon":162},{"facility":69,"status":39,"city":166,"state":167,"zip":168,"country":50,"countryCode":51,"cosmosGeoPoint":169,"geoPoint":173,"contacts":39},"Salt Lake City","Utah","84123",{"type":53,"coordinates":170},[171,172],-111.89105,40.76078,{"lat":172,"lon":171},{"facility":69,"status":39,"city":175,"state":167,"zip":176,"country":50,"countryCode":51,"cosmosGeoPoint":177,"geoPoint":181,"contacts":39},"West Jordan","84088",{"type":53,"coordinates":178},[179,180],-111.9391,40.60967,{"lat":180,"lon":179},{"type":183,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR","100318241","phase-3-lot-to-lot-consistency-of-3-lots-of-tetravalent-dengue-vaccine-tdv-in-non-endemic-countryies-for-dengue-100318241",true,"NCT03423173","Lot-to-lot Consistency of 3 Lots of Tetravalent Dengue Vaccine (TDV) in Non-endemic Country(Ies) for Dengue","A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Demonstrate Lot-to-Lot Consistency of 3 Lots of a Tetravalent Dengue Vaccine Candidate in Healthy Adults in Non-Endemic Country(Ies) for Dengue","Inclusion Criteria:\n\n1. Is in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs) and the clinical judgment of the Investigator.\n2. Signs and dates a written informed consent form and any required privacy authorization prior to the initiation of any trial procedures, after the nature of the trial has been explained according to local regulatory requirements.\n\nExclusion Criteria:\n\n1. Has an elevated oral temperature (≥38°C or 100.4°F) within 3 days of the intended date of vaccination.\n2. Known hypersensitivity or allergy to any of the vaccine components (including excipients of the investigational vaccine or placebo).\n3. Has any history of progressive or severe neurologic disorder, seizure disorder or neuro-inflammatory disease (e.g., Guillain-Barré syndrome).\n4. Known or suspected impairment\u002Falteration of immune function, including:\n\n   1. Chronic use of oral steroids (equivalent to 20 mg\u002Fday prednisone ≥12 weeks\u002F≥2 mg\u002Fkg body weight\u002Fday prednisone ≥2 weeks) within 60 days prior to Day 1 (M0) (use of inhaled, intranasal, or topical corticosteroids is allowed)\n   2. Receipt of parenteral steroids (equivalent to 20 mg\u002Fday prednisone ≥12 weeks\u002F≥ 2 mg\u002Fkg body weight\u002Fday prednisone ≥2 weeks) within 60 days prior to Day 1 (M0).\n   3. Administration of immunoglobulins and\u002For any blood products within the 3 months prior to Day 1 (M0) or planned administration during the trial.\n   4. Receipt of immunostimulants within 60 days prior to Day 1 (M0).\n   5. Hepatitis C virus infection.\n   6. Genetic immunodeficiency.\n5. Has abnormalities of splenic or thymic function.\n6. Has a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.\n7. Has any serious chronic or progressive disease according to judgment of the Investigator (e.g., neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease).\n8. Has body mass index (BMI) greater than or equal to 35 kg\u002Fm\\^2 (= weight in kg\u002F\\[height in meters\\^2\\]).\n9. Has history of substance or alcohol abuse within the past 2 years.\n10. Had previous and planned vaccination (during the trial conduct) against any flavivirus including dengue, yellow fever (YF), Japanese encephalitis (JE) viruses or tick-borne encephalitis.\n11. Has a current or previous infection with a flavivirus such as dengue, Zika, YF, JE, West Nile (WN) fever, tick-borne encephalitis or Murray Valley encephalitis and participants with a history of prolonged (≥1 year) habitation in a dengue endemic area.","ALL","18 Years","60 Years",{"count":195,"type":196},923,"ACTUAL","INTERVENTIONAL",[199],"PHASE3","The purpose of this study is to investigate lot-to-lot consistency in terms of equivalence of the immune responses induced by 3 consecutive TDV lots in healthy participants aged 18 to 60 years in non-endemic country(ies) for dengue.",[202],"Dengue Fever",[204],"Vaccine","COMPLETED","2020-10-15",{"date":208,"type":196},"2020-10-20",{"date":210,"type":196},"2018-02-12",{"date":212,"type":196},"2019-01-14",{"name":5,"class":6},14]