[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100253705":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":25,"locations":30,"responsibleParty":301,"collaborators":25,"id":303,"slug":304,"hasResults":305,"nctId":306,"briefTitle":307,"officialTitle":308,"acronym":25,"eligibilityCriteria":309,"healthyVolunteers":305,"sex":310,"minAge":311,"maxAge":25,"enrollmentInfo":312,"targetDuration":25,"studyType":315,"phases":316,"briefSummary":318,"conditions":319,"keywords":321,"overallStatus":327,"whyStopped":25,"lastUpdateSubmitDate":328,"lastUpdatePostDateStruct":329,"startDateStruct":331,"completionDateStruct":333,"leadSponsor":335,"locationsCount":336},{"fullName":5,"class":6},"GlaxoSmithKline","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"GSK1437173A Group","EXPERIMENTAL","Subjects ≥ 65 years of age who received Zostavax vaccine ≥ 5 years earlier and received 2 doses of the HZ\u002Fsu vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.",[13],"Biological: GSK Biologicals Herpes Zoster subunit (HZ\u002Fsu) vaccine (GSK 1437173A)",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group","ACTIVE_COMPARATOR","Subjects ≥ 65 years of age who never received Zostavax vaccine and received 2 doses of the HZ\u002Fsu vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BIOLOGICAL","GSK Biologicals Herpes Zoster subunit (HZ\u002Fsu) vaccine (GSK 1437173A)","2 doses administered by intramuscular (IM) injection into the deltoid muscle of the non-dominant arm.",[15,9],null,[27],{"name":28,"affiliation":5,"role":29},"GSK Clinical Trials","STUDY_DIRECTOR",[31,44,53,61,69,77,85,94,103,111,119,128,137,145,154,163,171,180,189,198,207,212,220,228,237,245,254,262,267,275,284,293],{"facility":32,"status":25,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":25},"GSK Investigational Site","Huntsville","Alabama","35802","United States","US",{"type":39,"coordinates":40},"Point",[41,42],-86.58594,34.7304,{"lat":42,"lon":41},{"facility":32,"status":25,"city":45,"state":46,"zip":47,"country":36,"countryCode":37,"cosmosGeoPoint":48,"geoPoint":52,"contacts":25},"Daly City","California","94015",{"type":39,"coordinates":49},[50,51],-122.46192,37.70577,{"lat":51,"lon":50},{"facility":32,"status":25,"city":54,"state":46,"zip":55,"country":36,"countryCode":37,"cosmosGeoPoint":56,"geoPoint":60,"contacts":25},"Los Gatos","95032",{"type":39,"coordinates":57},[58,59],-121.97468,37.22661,{"lat":59,"lon":58},{"facility":32,"status":25,"city":62,"state":46,"zip":63,"country":36,"countryCode":37,"cosmosGeoPoint":64,"geoPoint":68,"contacts":25},"Oakland","94612",{"type":39,"coordinates":65},[66,67],-122.2708,37.80437,{"lat":67,"lon":66},{"facility":32,"status":25,"city":70,"state":46,"zip":71,"country":36,"countryCode":37,"cosmosGeoPoint":72,"geoPoint":76,"contacts":25},"Roseville","95661",{"type":39,"coordinates":73},[74,75],-121.28801,38.75212,{"lat":75,"lon":74},{"facility":32,"status":25,"city":78,"state":46,"zip":79,"country":36,"countryCode":37,"cosmosGeoPoint":80,"geoPoint":84,"contacts":25},"Santa Rosa","95405",{"type":39,"coordinates":81},[82,83],-122.71443,38.44047,{"lat":83,"lon":82},{"facility":32,"status":25,"city":86,"state":87,"zip":88,"country":36,"countryCode":37,"cosmosGeoPoint":89,"geoPoint":93,"contacts":25},"Boise","Idaho","83642",{"type":39,"coordinates":90},[91,92],-116.20345,43.6135,{"lat":92,"lon":91},{"facility":32,"status":25,"city":95,"state":96,"zip":97,"country":36,"countryCode":37,"cosmosGeoPoint":98,"geoPoint":102,"contacts":25},"Lenexa","Kansas","66219",{"type":39,"coordinates":99},[100,101],-94.73357,38.95362,{"lat":101,"lon":100},{"facility":32,"status":25,"city":104,"state":96,"zip":105,"country":36,"countryCode":37,"cosmosGeoPoint":106,"geoPoint":110,"contacts":25},"Newton","67114",{"type":39,"coordinates":107},[108,109],-97.34504,38.04668,{"lat":109,"lon":108},{"facility":32,"status":25,"city":112,"state":96,"zip":113,"country":36,"countryCode":37,"cosmosGeoPoint":114,"geoPoint":118,"contacts":25},"Wichita","67207",{"type":39,"coordinates":115},[116,117],-97.33754,37.69224,{"lat":117,"lon":116},{"facility":32,"status":25,"city":120,"state":121,"zip":122,"country":36,"countryCode":37,"cosmosGeoPoint":123,"geoPoint":127,"contacts":25},"Auburn","Maine","04210",{"type":39,"coordinates":124},[125,126],-70.23117,44.09785,{"lat":126,"lon":125},{"facility":32,"status":25,"city":129,"state":130,"zip":131,"country":36,"countryCode":37,"cosmosGeoPoint":132,"geoPoint":136,"contacts":25},"Columbia","Maryland","21045",{"type":39,"coordinates":133},[134,135],-76.83942,39.24038,{"lat":135,"lon":134},{"facility":32,"status":25,"city":138,"state":130,"zip":139,"country":36,"countryCode":37,"cosmosGeoPoint":140,"geoPoint":144,"contacts":25},"Elkridge","21075",{"type":39,"coordinates":141},[142,143],-76.71358,39.21261,{"lat":143,"lon":142},{"facility":32,"status":25,"city":146,"state":147,"zip":148,"country":36,"countryCode":37,"cosmosGeoPoint":149,"geoPoint":153,"contacts":25},"Marlborough","Massachusetts","01752",{"type":39,"coordinates":150},[151,152],-71.55229,42.34593,{"lat":152,"lon":151},{"facility":32,"status":25,"city":155,"state":156,"zip":157,"country":36,"countryCode":37,"cosmosGeoPoint":158,"geoPoint":162,"contacts":25},"Binghamton","New York","13901",{"type":39,"coordinates":159},[160,161],-75.91797,42.09869,{"lat":161,"lon":160},{"facility":32,"status":25,"city":164,"state":156,"zip":165,"country":36,"countryCode":37,"cosmosGeoPoint":166,"geoPoint":170,"contacts":25},"Endwell","13760",{"type":39,"coordinates":167},[168,169],-76.02103,42.11285,{"lat":169,"lon":168},{"facility":32,"status":25,"city":172,"state":173,"zip":174,"country":36,"countryCode":37,"cosmosGeoPoint":175,"geoPoint":179,"contacts":25},"Charlotte","North Carolina","28209",{"type":39,"coordinates":176},[177,178],-80.84313,35.22709,{"lat":178,"lon":177},{"facility":32,"status":25,"city":181,"state":182,"zip":183,"country":36,"countryCode":37,"cosmosGeoPoint":184,"geoPoint":188,"contacts":25},"Cleveland","Ohio","44122",{"type":39,"coordinates":185},[186,187],-81.69541,41.4995,{"lat":187,"lon":186},{"facility":32,"status":25,"city":190,"state":191,"zip":192,"country":36,"countryCode":37,"cosmosGeoPoint":193,"geoPoint":197,"contacts":25},"Corvallis","Oregon","97330",{"type":39,"coordinates":194},[195,196],-123.26204,44.56457,{"lat":196,"lon":195},{"facility":32,"status":25,"city":199,"state":200,"zip":201,"country":36,"countryCode":37,"cosmosGeoPoint":202,"geoPoint":206,"contacts":25},"Erie","Pennsylvania","16506",{"type":39,"coordinates":203},[204,205],-80.08506,42.12922,{"lat":205,"lon":204},{"facility":32,"status":25,"city":199,"state":200,"zip":208,"country":36,"countryCode":37,"cosmosGeoPoint":209,"geoPoint":211,"contacts":25},"16508",{"type":39,"coordinates":210},[204,205],{"lat":205,"lon":204},{"facility":32,"status":25,"city":213,"state":200,"zip":214,"country":36,"countryCode":37,"cosmosGeoPoint":215,"geoPoint":219,"contacts":25},"Philadelphia","19107",{"type":39,"coordinates":216},[217,218],-75.16362,39.95238,{"lat":218,"lon":217},{"facility":32,"status":25,"city":221,"state":200,"zip":222,"country":36,"countryCode":37,"cosmosGeoPoint":223,"geoPoint":227,"contacts":25},"Uniontown","15401",{"type":39,"coordinates":224},[225,226],-79.71643,39.90008,{"lat":226,"lon":225},{"facility":32,"status":25,"city":229,"state":230,"zip":231,"country":36,"countryCode":37,"cosmosGeoPoint":232,"geoPoint":236,"contacts":25},"Mt. Pleasant","South Carolina","29464",{"type":39,"coordinates":233},[234,235],-79.86259,32.79407,{"lat":235,"lon":234},{"facility":32,"status":25,"city":238,"state":230,"zip":239,"country":36,"countryCode":37,"cosmosGeoPoint":240,"geoPoint":244,"contacts":25},"Spartanburg","29303",{"type":39,"coordinates":241},[242,243],-81.93205,34.94957,{"lat":243,"lon":242},{"facility":32,"status":25,"city":246,"state":247,"zip":248,"country":36,"countryCode":37,"cosmosGeoPoint":249,"geoPoint":253,"contacts":25},"Layton","Utah","84041",{"type":39,"coordinates":250},[251,252],-111.97105,41.06022,{"lat":252,"lon":251},{"facility":32,"status":25,"city":255,"state":247,"zip":256,"country":36,"countryCode":37,"cosmosGeoPoint":257,"geoPoint":261,"contacts":25},"Salt Lake City","84109",{"type":39,"coordinates":258},[259,260],-111.89105,40.76078,{"lat":260,"lon":259},{"facility":32,"status":25,"city":255,"state":247,"zip":263,"country":36,"countryCode":37,"cosmosGeoPoint":264,"geoPoint":266,"contacts":25},"84121",{"type":39,"coordinates":265},[259,260],{"lat":260,"lon":259},{"facility":32,"status":25,"city":268,"state":247,"zip":269,"country":36,"countryCode":37,"cosmosGeoPoint":270,"geoPoint":274,"contacts":25},"South Jordan","84095",{"type":39,"coordinates":271},[272,273],-111.92966,40.56217,{"lat":273,"lon":272},{"facility":32,"status":25,"city":276,"state":277,"zip":278,"country":36,"countryCode":37,"cosmosGeoPoint":279,"geoPoint":283,"contacts":25},"Newport News","Virginia","23606",{"type":39,"coordinates":280},[281,282],-76.42975,36.98038,{"lat":282,"lon":281},{"facility":32,"status":25,"city":285,"state":286,"zip":287,"country":36,"countryCode":37,"cosmosGeoPoint":288,"geoPoint":292,"contacts":25},"Eau Claire","Wisconsin","54701",{"type":39,"coordinates":289},[290,291],-91.49849,44.81135,{"lat":291,"lon":290},{"facility":32,"status":25,"city":294,"state":286,"zip":295,"country":36,"countryCode":37,"cosmosGeoPoint":296,"geoPoint":300,"contacts":25},"Marshfield","54449",{"type":39,"coordinates":297},[298,299],-90.1718,44.66885,{"lat":299,"lon":298},{"type":302,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100253705","phase-3-immunogenicity-and-safety-study-of-glaxosmithkline-gsk-biologicals-herpes-zoster-subunit-hzsu-vaccine-gsk1437173a-in-adults--65-years-of-age-with-and-without-zostavax-vaccination-at-least-5-years-earlier-100253705",true,"NCT02581410","Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Subunit (HZ\u002Fsu) Vaccine (GSK1437173A) in Adults ≥ 65 Years of Age With and Without Zostavax® Vaccination at Least 5 Years Earlier","Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults ≥ 65 Years of Age With and Without Zostavax® Vaccination at Least 5 Years Earlier","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 ≥ 65 years of age at the time of the first vaccination.\n* Written informed consent obtained from the subject prior to performing any study specific procedure.\n\nFor the No prev-Zvax group only:\n\n• No previous vaccination with Zostavax.\n\nFor the Prev-Zvax group only:\n\n• Previous vaccination with Zostavax ≥ 5 calendar years earlier.\n\n* Documentation indicating the date of previous Zostavax vaccination will be required.\n\nExclusion Criteria:\n\n* Previous vaccination with Zostavax \\\u003C 5 calendar years earlier and\u002For anyone that ever received more than a single dose of Zostavax.\n* Previous vaccination against VZV, administration of HZ\u002Fsu vaccine or any other investigational or non-registered HZ vaccine (except Zostavax for the Prev-Zvax group).\n* Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before the first dose of study vaccine, or planned use during the study period.\n* Chronic administration (defined as \\> 14 consecutive days) of immunosuppressants or other immune-modifying drugs in the period starting 6 months prior to the first dose of vaccine. (For corticosteroids, a prednisone dose of \\\u003C 20 mg\u002Fday, or equivalent, is allowed.) Inhaled, topical and intra-articular corticosteroids are allowed.\n* Administration of long-acting immune-modifying drugs (e.g., infliximab) in the period starting 6 months prior to the first vaccine dose or expected administration at any time during the study period.\n* Administration or planned administration of a live vaccine in the period starting 30 days before the first dose of study vaccine and ending 30 days after the last dose of study vaccine, or, administration or planned administration of a non-replicating vaccine in the period starting 8 days prior to and ending 14 days after either dose of study vaccine.\n* Current participation in or planned concurrent participation 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 product.\n* Planned administration of an HZ vaccine (including an investigational or non-registered vaccine) other than the study vaccine during the entire study.\n* History of HZ or any suspected HZ between the screening visit and Visit 1.\n* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine\u002Fproduct.\n* Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., malignancy, human immunodeficiency virus \\[HIV\\] infection) or immunosuppressive\u002Fcytotoxic therapy (e.g., medications used during cancer chemotherapy, organ transplantation or to treat autoimmune disorders).\n* Acute disease and\u002For fever at the time of enrolment.\n\n  * Fever is defined as temperature ≥ 37.5°C (99.5°F) by oral route, axillary or tympanic setting, or ≥ 38.0°C\u002F100.4°F on rectal setting. The recommended route for recording temperature in this study will be oral.\n  * Subjects with a minor illness (such as mild diarrhea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.\n* Administration of immunoglobulins and\u002For any blood products in the period starting 3 months preceding the first dose of study vaccine or planned administration during the study period.\n* Significant underlying illness that, in the opinion of the investigator, would be expected to prevent completion of the study.\n* Any other condition that, in the opinion of the investigator, might interfere with the evaluations required by the study.\n* Any condition which, in the judgment of the investigator, would make intramuscular (IM) injection unsafe.","ALL","65 Years",{"count":313,"type":314},430,"ACTUAL","INTERVENTIONAL",[317],"PHASE3","The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals' HZ\u002Fsu vaccine in adults ≥ 65 years of age with and without Zostavax® vaccination at least 5 years earlier.",[320],"Herpes Zoster",[322,323,320,324,325,326],"Zostavax®","≥ 65 years of age","Shingles","Immunogenicity","Safety","COMPLETED","2018-07-30",{"date":330,"type":314},"2018-08-28",{"date":332,"type":314},"2015-12-15",{"date":334,"type":314},"2017-08-01",{"name":5,"class":6},32]