[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100225090":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":57,"centralContacts":34,"locations":61,"responsibleParty":90,"collaborators":34,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":34,"eligibilityCriteria":98,"healthyVolunteers":94,"sex":99,"minAge":100,"maxAge":101,"enrollmentInfo":102,"targetDuration":34,"studyType":105,"phases":106,"briefSummary":108,"conditions":109,"keywords":111,"overallStatus":121,"whyStopped":34,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"GlaxoSmithKline","INDUSTRY",[8,17,23],{"label":9,"type":10,"description":11,"interventionNames":12},"GSK257049 Group","EXPERIMENTAL","Male or female infants (between and including 6 to 12 weeks of age)\u002Fchildren (between and including 5 to 17 months of age) received 3 doses of GSK257049 malaria vaccine (co-administered with Polio Sabin and Tritanrix HepB\u002FHib vaccines, for the infants subgroup) on a 0-1-2-month schedule, and a booster dose of GSK257049 malaria vaccine (co-administered with Polio Sabin, for the infants subgroup) at Month 20 during the primary study MALARIA-055 PRI (NCT00866619). Vaccines were administered intramuscularly: in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB\u002FHib vaccine); orally: Polio Sabin vaccine. No vaccination was administered during this study.",[13,14,15,16],"Procedure: Blood sampling","Biological: Malaria Vaccine 257049 (MALARIA-055 PRI)","Biological: TritanrixHepB\u002FHib (MALARIA-055 PRI)","Biological: Polio Sabin Oral Polio Vaccine (GSK) (MALARIA-055 PRI)",{"label":18,"type":19,"description":20,"interventionNames":21},"GSK257049 Comparator Group","ACTIVE_COMPARATOR","Male or female infants (between and including 6 to 12 weeks of age)\u002Fchildren (between and including 5 to 17 months of age) received 3 doses of GSK257049 malaria vaccine (co-administered with Polio Sabin and Tritanrix HepB\u002FHib vaccines, for the infants subgroup) on 0-1-2-month schedule, and a booster dose of Menjugate vaccine (co-administered with Polio Sabin, for the infants subgroup) at Month 20 during the primary study MALARIA-055 PRI (NCT00866619). Vaccines were administered intramuscularly: in the anterolateral left thigh (GSK257049 vaccine); anterolateral right thigh (Tritanrix HepB\u002FHib vaccine); orally: Polio Sabin vaccine. No vaccination was administered during this study.",[13,14,22,15,16],"Biological: Meningococcal C Conjugate Vaccine (MALARIA-055 PRI)",{"label":24,"type":19,"description":25,"interventionNames":26},"VeroRab\u002FMenjugate Comparator Group","Male or female infants (between and including 6 to 12 weeks of age)\u002Fchildren (between and including 5 to 17 months of age) received 3 doses of VeroRab vaccine (children subgroup) or Menjugate vaccine (co-administered with Polio Sabin and Tritanrix HepB\u002FHib vaccines, for the infants subgroup) on 0-1-2-month schedule, and a booster dose of Menjugate vaccine (co-administered with Polio Sabin, for the infants subgroup) at Month 20 during the primary study MALARIA-055 PRI (NCT00866619). Vaccines were administered intramuscularly: left deltoid (VeroRab vaccine and Menjugate vaccine); anterolateral right thigh (Tritanrix HepB\u002FHib vaccine); orally: Polio Sabin vaccine. No vaccination was administered during this study.",[13,22,27,15,16],"Biological: Cell-culture rabies vaccine (MALARIA-055 PRI)",[29,35,40,45,50,53],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"PROCEDURE","Blood sampling","Annual blood sampling (Year 1, Year 2 and Year 3) during the present study.",[18,9,24],null,{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":34},"BIOLOGICAL","Malaria Vaccine 257049 (MALARIA-055 PRI)","Administered intramuscularly into the left deltoid, during the MALARIA-055 study (NCT00866619).",[18,9],{"type":36,"name":41,"description":38,"armGroupLabels":42,"otherNames":43},"Meningococcal C Conjugate Vaccine (MALARIA-055 PRI)",[18,24],[44],"Menjugate",{"type":36,"name":46,"description":38,"armGroupLabels":47,"otherNames":48},"Cell-culture rabies vaccine (MALARIA-055 PRI)",[24],[49],"VeroRab",{"type":36,"name":51,"description":38,"armGroupLabels":52,"otherNames":34},"TritanrixHepB\u002FHib (MALARIA-055 PRI)",[18,9,24],{"type":36,"name":54,"description":55,"armGroupLabels":56,"otherNames":34},"Polio Sabin Oral Polio Vaccine (GSK) (MALARIA-055 PRI)","Administered orally, during the MALARIA-055 study (NCT00866619).",[18,9,24],[58],{"name":59,"affiliation":5,"role":60},"GSK Clinical Trials","STUDY_DIRECTOR",[62,73,82],{"facility":63,"status":34,"city":64,"state":34,"zip":34,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":34},"GSK Investigational Site","Ouagadougou","Burkina Faso","BF",{"type":68,"coordinates":69},"Point",[70,71],-1.53388,12.36566,{"lat":71,"lon":70},{"facility":63,"status":34,"city":74,"state":34,"zip":34,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":81,"contacts":34},"Kisumu","Kenya","KE",{"type":68,"coordinates":78},[79,80],34.76171,-0.10221,{"lat":80,"lon":79},{"facility":63,"status":34,"city":83,"state":34,"zip":34,"country":84,"countryCode":34,"cosmosGeoPoint":85,"geoPoint":89,"contacts":34},"Tanga","Tanzania",{"type":68,"coordinates":86},[87,88],39.09875,-5.06893,{"lat":88,"lon":87},{"type":91,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR","100225090","phase-3-an-extension-to-study-malaria-055-pri-nct00866619-to-evaluate-the-long-term-efficacy-safety-and-immunogenicity-of-gsk-biologicals-candidate-malaria-vaccine-in-infants-and-children-in-africa-100225090",true,"NCT02207816","An Extension to Study MALARIA-055 PRI (NCT00866619) to Evaluate the Long-term Efficacy, Safety and Immunogenicity of GSK Biologicals' Candidate Malaria Vaccine in Infants and Children in Africa","Extension to Study MALARIA-055 PRI (NCT00866619) for Evaluation of Long-term Efficacy, Safety and Immunogenicity of GSK Biologicals' Candidate Malaria Vaccine (SB257049) in Infants and Children in Africa","Inclusion Criteria:\n\n* Subjects' parent(s)\u002F Legally Acceptable Representative (LARs) who, in the opinion of the investigator, can and will comply with the requirements of the protocol.\n* Subjects who were enrolled and who received at least one vaccine dose in the primary study MALARIA-055 PRI NCT00866619 and who did not withdraw consent (except those who moved away from the area) during the primary study MALARIA-055 PRI NCT00866619.\n* Written informed consent obtained from the parent(s)\u002FLAR(s) of the subject.\n\nExclusion Criteria:\n\n* Child in care.\n* Use of any investigational or non-registered product or planned use during the study period.","ALL","42 Months","9 Years",{"count":103,"type":104},3084,"ACTUAL","INTERVENTIONAL",[107],"PHASE3","The purpose of this study is to conduct long-term surveillance for efficacy, safety and immunogenicity of the GSK Biologicals RTS,S\u002FAS01E candidate Plasmodium falciparum malaria vaccine in infants and children in Africa following a primary vaccination series (NCT00866619). No new subjects will be enrolled in this extension study.",[110],"Malaria",[112,113,114,110,115,116,117,118,119,120],"Infants","Efficacy","Children","Plasmodium falciparum","Safety","Surveillance","Immunogenicity","RTS,S\u002FAS01E","Africa","COMPLETED","2019-11-14",{"date":124,"type":104},"2019-11-25",{"date":126,"type":104},"2014-09-18",{"date":128,"type":104},"2017-01-31",{"name":5,"class":6},3]