[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100219564":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":24,"locations":29,"responsibleParty":41,"collaborators":24,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":24,"eligibilityCriteria":49,"healthyVolunteers":50,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":24,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":64,"overallStatus":72,"whyStopped":73,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"GlaxoSmithKline","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"2-dose Primed Group","EXPERIMENTAL","Adolescent subjects in this group received 2 doses of Twinrix Adult (720\u002F20) (licensed as Ambirix in the EU) according to a 0, 6 months schedule in the primary study HAB-084 (208127\u002F084).",[13],"Procedure: Blood sampling",{"label":15,"type":10,"description":16,"interventionNames":17},"3-dose Primed Group","Adolescent subjects in this group received 3 doses of Twinrix Junior (360\u002F10) according to a 0, 1, 6 months schedule in the primary study HAB-084 (208127\u002F084).",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"PROCEDURE","Blood sampling","At Years 16 - 20 after first dose of the primary vaccination in HAB-084 (208127\u002F084) study.",[9,15],null,[26],{"name":27,"affiliation":5,"role":28},"GSK Clinical Trials","STUDY_DIRECTOR",[30],{"facility":31,"status":24,"city":32,"state":24,"zip":33,"country":34,"countryCode":24,"cosmosGeoPoint":35,"geoPoint":40,"contacts":24},"GSK Investigational Site","Hradec Králové","500 01","Czechia",{"type":36,"coordinates":37},"Point",[38,39],15.83277,50.20923,{"lat":39,"lon":38},{"type":42,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100219564","phase-4-evaluation-of-the-long-term-hepatitis-a-and-b-antibody-persistence-in-healthy-adult-subjects-primed-16-to-20-years-earlier-with-gsk-biologicals-combined-hepatitis-a-and-b-vaccine-twinrix-sb208127-in-study-hab-084-208127084-100219564",false,"NCT02135666","Evaluation of the Long-term Hepatitis A and B Antibody Persistence in Healthy Adult Subjects, Primed 16 to 20 Years Earlier With GSK Biologicals' Combined Hepatitis A and B Vaccine, Twinrix® (SB208127) in Study HAB-084 (208127\u002F084)","Long-term Hepatitis A and B Antibody Persistence in Healthy Adult Subjects, Primed 16 to 20 Years Earlier With GSK Biologicals' Combined Hepatitis A and B Vaccine, Twinrix® (SB208127) in Study HAB-084 (208127\u002F084)","Inclusion Criteria:\n\n* Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.\n* A male or female who received two\u002Fthree doses of Twinrix according to his\u002Fher group allocation in study HAB-084 (208127\u002F084), and received no further dose of any hepatitis A and\u002For B vaccine since then.\n* Written informed consent obtained from the subject.\n\nExclusion Criteria:\n\n* Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to study entry. Inhaled and topical steroids are allowed.\n* Administration of long-acting immune-modifying drugs within six months prior to the study entry.\n* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine\u002Fproduct (pharmaceutical product or device).\n* Administration of any hepatitis A and\u002For B vaccine at any time since completion of the primary vaccination series in HAB-084 (208127\u002F084) study, including a challenge dose of the study vaccine, as a part of the study procedures, during the long-term persistence phase.\n* Documented history of hepatitis A or B disease since completion of the primary vaccination series in HAB-084 (208127\u002F084) study.\n* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).\n* Administration of immunoglobulins within six months prior to study entry.",true,"ALL","18 Years","64 Years",{"count":55,"type":56},0,"ACTUAL","INTERVENTIONAL",[59],"PHASE4","The purpose of this study is to assess the long-term persistence of immunity to hepatitis A and B in adults who were vaccinated 16-20 years earlier with the combined hepatitis A and hepatitis B vaccine, Twinrix.",[62,63],"Hepatitis B","Hepatitis A",[65,66,67,63,68,69,62,70,71],"Twinrix","Long-term follow-up","Persistence","Antibody","Immunity","Combination vaccine","Adult","WITHDRAWN","This study has been cancelled before initiation due to company's prioritisation decisions linked to resources restrictions.","2015-11-16",{"date":76,"type":77},"2015-11-18","ESTIMATED",{"date":79,"type":24},"2015-05",{"date":81,"type":77},"2019-10",{"name":5,"class":6},1]