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Cape","6850",{"type":49,"coordinates":113},[114,115],19.44852,-33.64651,{"lat":115,"lon":114},{"facility":43,"status":22,"city":118,"state":22,"zip":119,"country":71,"countryCode":72,"cosmosGeoPoint":120,"geoPoint":124,"contacts":22},"Bloemfontein","9301",{"type":49,"coordinates":121},[122,123],26.214,-29.12107,{"lat":123,"lon":122},{"facility":43,"status":22,"city":126,"state":22,"zip":127,"country":71,"countryCode":72,"cosmosGeoPoint":128,"geoPoint":132,"contacts":22},"Paarl","7626",{"type":49,"coordinates":129},[130,131],18.97523,-33.73378,{"lat":131,"lon":130},{"type":134,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","100130143","phase-3-safety-and-immunogenicity-of-13-valent-pneumococcal-conjugate-vaccine-13vpnc-in-hiv-infected-subjects-6-years-of-age-or-older-who-are-naive-to-pneumococcal-vaccine-100130143",true,"NCT00962780","Safety and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) in HIV-Infected Subjects 6 Years of Age or Older Who Are Naive to Pneumococcal Vaccine","A Phase 3, Open-label, Single-Arm Trial to Evaluate the Safety, Tolerability and Immunogenicity of 2 and 3 Doses of 13vPnC in HIV-Infected Subjects 6 Years of Age and Older Who Have Not Been Previously Immunized With Pneumococcal Vaccine","Inclusion Criteria:\n\n* Human immunodeficiency virus (HIV)-infected subjects aged 6 years or older\n* Viral load \\\u003C 50,000 copies\u002FmL and CD4+ T cell count \\>= 200\u002FuL within 6 months before study vaccination\n* Receiving stable highly active antiretroviral therapy (HAART) or not currently receiving any antiretroviral therapy\n* No previous vaccination with a pneumococcal vaccine\n* Subject or parent\u002Flegal guardian able to complete an electronic diary\n\nExclusion Criteria:\n\n* Acquired immune deficiency syndrome (AIDS) at time of enrollment\n* Current illicit substance and\u002For alcohol abuse\n* History of active chronic viral hepatitis\n* Previous anaphylactic reaction to a vaccine or vaccine-related component\n* Serious chronic disorders including metastatic malignancy and end-stage renal disease",false,"ALL","6 Years",{"count":146,"type":147},303,"ACTUAL","INTERVENTIONAL",[150],"PHASE3","The study will evaluate the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate vaccine (13vPnC) in HIV-infected subjects 6 years of age or older who have not been previously immunized with a pneumococcal vaccine. All subjects will receive 3 doses of 13vPnC and 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS), with each dose given approximately 1 month apart.",[153,154],"HIV Infections","Pneumococcal Infections",[156,157,158,159],"vaccine","13-valent pneumococcal conjugate vaccine","23-valent pneumococcal polysaccharide vaccine","human immunodeficiency virus","COMPLETED","2014-11-13",{"date":163,"type":164},"2014-11-17","ESTIMATED",{"date":166,"type":22},"2010-03",{"date":168,"type":147},"2013-04",{"name":5,"class":6},11]