[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100140638":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":26,"centralContacts":10,"locations":30,"responsibleParty":50,"collaborators":10,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":10,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":10,"studyType":65,"phases":10,"briefSummary":66,"conditions":67,"keywords":69,"overallStatus":75,"whyStopped":10,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"GlaxoSmithKline","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Cervarix Group",null,"Subjects received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule is necessary, the second dose can be administered between 1 month and 2.5 months after the first dose.",[13,14],"Biological: Cervarix.","Other: Data collection",[16,21],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":10},"BIOLOGICAL","Cervarix.","Subjects will receive three doses of the Cervarix vaccine administered intramuscularly according to a 0, 1, 6 month vaccination schedule in routine clinical practice settings.",[9],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":10},"OTHER","Data collection","All adverse events will be recorded by all subjects or the subject's parents\u002Fguardians using diary cards.",[9],[27],{"name":28,"affiliation":5,"role":29},"GSK Clinical Trials","STUDY_DIRECTOR",[31,42],{"facility":32,"status":10,"city":33,"state":10,"zip":34,"country":35,"countryCode":10,"cosmosGeoPoint":36,"geoPoint":41,"contacts":10},"GSK Investigational Site","Busan","602-702","South Korea",{"type":37,"coordinates":38},"Point",[39,40],129.03004,35.10168,{"lat":40,"lon":39},{"facility":32,"status":10,"city":43,"state":10,"zip":44,"country":35,"countryCode":10,"cosmosGeoPoint":45,"geoPoint":49,"contacts":10},"Seoul","138-736",{"type":37,"coordinates":46},[47,48],126.9784,37.566,{"lat":48,"lon":47},{"type":51,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100140638","evaluation-of-safety-of-a-vaccine-against-cervical-cancer-in-healthy-korean-females-100140638",true,"NCT01101542","Evaluation of Safety of a Vaccine Against Cervical Cancer in Healthy Korean Females","Safety of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV)-16\u002F18 Vaccine, Cervarix® When Administered to Healthy Females According to the Prescribing Information in Korea","Inclusion Criteria:\n\n* Female subjects aged between and including, 10 to 25 years at the time of the first vaccination.\n* Subjects who the investigator believes that they or their parents\u002Fguardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for vaccination visits etc) should be enrolled in the PMS.\n* Written informed consent obtained from the subject or the subjects' parent\u002F guardian.\n* Subjects of childbearing potential must not be pregnant. Absence of pregnancy should be verified (e.g. urine pregnancy test) as per the investigator's clinical judgement.\n* Subjects with no contraindication according to the local approved prescribing information.\n* No previous administration of an HPV vaccine other than Cervarix®.\n* No previous administration of more than two doses of Cervarix®.\n* No planned administration of an HPV vaccine other than Cervarix® during the PMS","FEMALE","10 Years","25 Years",{"count":63,"type":64},3091,"ACTUAL","OBSERVATIONAL","This Post Marketing Surveillance (PMS) will collect safety data on the use of GSK Biologicals' human papillomavirus (HPV) vaccine in the local target population of females as per the regulations of the Korean Food and Drugs Administration (KFDA).",[68],"Infections, Papillomavirus",[70,71,72,73,74],"Post-marketing surveillance","Human papillomavirus","Korea","Safety","Prescribing Information","COMPLETED","2018-05-25",{"date":78,"type":64},"2018-07-23",{"date":80,"type":10},"2010-07-01",{"date":82,"type":64},"2014-02-20",{"name":5,"class":6},2]