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City","833","Taiwan","TW",{"type":43,"coordinates":276},[277,278],120.31333,22.61626,{"lat":278,"lon":277},{"facility":37,"status":26,"city":281,"state":26,"zip":282,"country":273,"countryCode":274,"cosmosGeoPoint":283,"geoPoint":287,"contacts":26},"Keelung","204",{"type":43,"coordinates":284},[285,286],121.74094,25.13089,{"lat":286,"lon":285},{"facility":37,"status":26,"city":289,"state":26,"zip":290,"country":273,"countryCode":274,"cosmosGeoPoint":291,"geoPoint":295,"contacts":26},"Taichung","407",{"type":43,"coordinates":292},[293,294],120.6839,24.1469,{"lat":294,"lon":293},{"facility":37,"status":26,"city":297,"state":26,"zip":298,"country":273,"countryCode":274,"cosmosGeoPoint":299,"geoPoint":303,"contacts":26},"Taipei","100",{"type":43,"coordinates":300},[301,302],121.52639,25.05306,{"lat":302,"lon":301},{"facility":37,"status":26,"city":305,"state":26,"zip":306,"country":273,"countryCode":274,"cosmosGeoPoint":307,"geoPoint":311,"contacts":26},"Taoyuan","333",{"type":43,"coordinates":308},[309,310],121.29696,24.99368,{"lat":310,"lon":309},{"type":313,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100213669","phase-3-immunogenicity-and-safety-of-glaxosmithkline-gsk-biologicals-herpes-zoster-subunit-hzsu-vaccine-in-adults-18-years-of-age-or-older-with-renal-transplant-100213669",true,"NCT02058589","Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Subunit (HZ\u002Fsu) Vaccine in Adults 18 Years of Age or Older With Renal Transplant","Observer-blind Study to Evaluate Immunogenicity and Safety of GSK Biologicals' Herpes Zoster Subunit (HZ\u002Fsu) Vaccine GSK1437173A in Adults 18 Years of Age or Older With Renal Transplant","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, aged 18 years or older and having reached the age of legal consent, on the date the informed consent is signed.\n* Written informed consent obtained from the subject.\n* Subject who has received an ABO compatible allogeneic renal transplant.\n* Subject receiving maintenance immunosuppressive therapy for the prevention of allograft rejection for a minimum of one month (30 days) prior to the first vaccination.\n* Subject without an episode of allograft rejection over the previous three months (90 days) prior to the first vaccination.\n* Subject with stable renal function, stability defined as:\n\n  * less than 20% variability between last two creatinine measurements or calculated GFR\n  * or in the opinion of the investigator after investigator review of more than the last two creatinine measurements or calculated GFRs.\n* Subject not less than 4 months (120 days) and not more than 18 months (547 days) after allograft transplantation at the time of the first vaccination.\n* Subjects with multiple dialysis options (peritoneal and\u002For more than one anatomical access site for haemodialysis) in the event acute or chronic dialysis is needed.\n* Female subjects of non-childbearing potential may be enrolled in the study.\n* Female subjects of childbearing potential may be enrolled in the study, if the subject:\n\n  * has practiced adequate contraception for 30 days prior to vaccination, and\n  * has a negative pregnancy test on the day of the first vaccination, and\n  * has agreed to continue adequate contraception during the primary treatment period and for 2 months after completion of the vaccination series.\n\nExclusion Criteria:\n\n* Any primary kidney disease with a high incidence of recurrent primary kidney disease.\n* Evidence of recurrent primary kidney disease within the current allograft.\n* Previous allograft loss secondary to recurrent primary kidney disease.\n\n  * Multiple kidney transplants are allowed if the reason for a previous allograft's loss is not recurrent primary kidney disease.\n* More than one organ transplanted (i.e. kidney-liver, double kidney or kidney-other organ(s) transplanted).\n* History of events that, in the opinion of the investigator, may put subject at increased risk for chronic allograft dysfunction (e.g. delayed graft function, peri-operative complications).\n* Histologic reports of chronic allograft injury (e.g. transplant glomerulopathy, arteriopathy, C4d deposition).\n* Evidence of significant proteinuria in the opinion of the investigator.\n* Panel reactive antibody score (PRA or cPRA) that is unknown at the time of transplant.\n* Any autoimmune or potential immune-mediated disease including primary kidney disease.\n* Use of anti-CD20 or other B-cell monoclonal antibody agents (e.g., rituximab) as induction, maintenance and\u002For therapeutic immunosuppressive therapy for the prevention of allograft rejection within 9 months (274 days) of first dose of study vaccine\u002Fplacebo.\n* Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine\u002Fplacebo, or planned use during the study period.\n* Concurrent or planned participation in another clinical study, at any time during the study period, which has exposed or will expose the subject to an investigational or a non-registered product\n* Administration or planned administration of a live vaccine within 30 days prior to 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 within 8 days prior to or within 14 days after either dose of study vaccine.\n* Planned administration during the study of a varicella or HZ vaccine other than the study vaccine.\n* Previous vaccination against HZ or varicella within the 12 months preceding the first dose of study vaccine\u002Fplacebo.\n* Occurrence of varicella or HZ per clinical history, within the 12 months preceding the first dose of study vaccine\u002Fplacebo.\n* Failure to fully complete the 7-day pre-vaccination diary card distributed at the Pre-vaccination visit.\n* Evidence or high suspicion, in the opinion of the investigator, of noncompliance or nonadherence to use of induction and\u002For maintenance immunosuppressive therapies.\n* Any confirmed or suspected HIV, primary immunodeficiency disease, disseminated or untreated malignancy, or systemic infection.\n* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine or study material and equipment.\n* Any condition which, in the judgment of the investigator, would make intramuscular injection unsafe.\n* Any other condition that, in the opinion of the investigator, might interfere with the evaluations required by the study.\n* Acute disease and\u002For fever at the time of vaccination.\n\n  * Fever is defined as temperature ≥ 37.5°C \u002F99.5°F by oral route. The preferred route for recording temperature in this study will be oral.\n  * Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.\n* Pregnant or lactating female.\n* Female planning to become pregnant or planning to discontinue contraceptive precautions (if of childbearing potential) before Month 3.",false,"ALL","18 Years",{"count":325,"type":326},265,"ACTUAL","INTERVENTIONAL",[329],"PHASE3","The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals' HZ\u002Fsu vaccine administered on a 0- and 1- to 2-months schedule in adults 18 years of age or older who are receiving chronic immunosuppressive therapy.",[332],"Herpes Zoster",[334,335,336,337,338,339,340,341],"Immunocompromised","Safety","≥ 18 years of age","Renal transplant","Adults","Immunosuppressed","Immunogenicity","Herpes zoster","COMPLETED","2018-06-14",{"date":345,"type":326},"2018-08-01",{"date":347,"type":326},"2014-03-20",{"date":349,"type":326},"2017-04-13",{"name":5,"class":6},34]