[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100082083":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":28,"centralContacts":27,"locations":32,"responsibleParty":54,"collaborators":27,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":27,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":27,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":27,"overallStatus":79,"whyStopped":27,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"GlaxoSmithKline","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Infanrix Hexa Group","EXPERIMENTAL","Healthy male or female subjects between and including 11 to 17 weeks of age, who were previously vaccinated with Rotarix™ in study 444563\u002F028 (NCT00197210), additionally received 2 doses of Infanrix™-IPV\u002FHib vaccine (at 3 and 4 months of age), 2 doses of Rotarix™ vaccine (at 2 and 4 months of age) and one dose of Infanrix Hexa™ vaccine (at 5 months of age) as a primary vaccination course, followed by administration of a booster dose of Infanrix™-IPV\u002FHib vaccine (at 18 months of age). The Infanrix™-IPV\u002FHib and Infanrix Hexa™ vaccines were administered intramuscularly into the right antero-lateral thigh, while the Rotarix™ vaccine was given orally.",[13,14],"Biological: DTPa-HBV-IPV\u002FHib","Biological: DTPa-IPV\u002FHib vaccine",[16,23],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"BIOLOGICAL","DTPa-HBV-IPV\u002FHib","1 intramuscular injection (3rd study vaccine dose)",[9],[22],"INFANRIX HEXA™",{"type":17,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DTPa-IPV\u002FHib vaccine","3 intramuscular injections (1st, 2nd and 4th vaccine dose)",[9],null,[29],{"name":30,"affiliation":5,"role":31},"GSK Clinical Trials","STUDY_DIRECTOR",[33,44,49],{"facility":34,"status":27,"city":35,"state":27,"zip":36,"country":35,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":27},"GSK Investigational Site","Singapore","119074","SG",{"type":39,"coordinates":40},"Point",[41,42],103.85007,1.28967,{"lat":42,"lon":41},{"facility":34,"status":27,"city":35,"state":27,"zip":45,"country":35,"countryCode":37,"cosmosGeoPoint":46,"geoPoint":48,"contacts":27},"228510",{"type":39,"coordinates":47},[41,42],{"lat":42,"lon":41},{"facility":34,"status":27,"city":35,"state":27,"zip":50,"country":35,"countryCode":37,"cosmosGeoPoint":51,"geoPoint":53,"contacts":27},"229899",{"type":39,"coordinates":52},[41,42],{"lat":42,"lon":41},{"type":55,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100082083","phase-3-safety-of-dtpa-ipvhib--dtpa-hbv-ipvhib-followed-by-dtpa-ipvhib-vaccine-in-infants-who-received-hepatitis-b-vaccine-100082083",true,"NCT00325143","Safety of DTPa-IPV\u002FHib & DTPa-HBV-IPV\u002FHib, Followed by DTPa-IPV\u002FHib Vaccine in Infants Who Received Hepatitis B Vaccine","Assess Safety & Reactogenicity of DTPa-IPV\u002FHib Vaccine Admnd at 3 & 4 Mths & DTPa-HBV-IPV\u002FHib Vaccine Admnd at 5 Mths, Followed by DTPa-IPV\u002FHib Vaccine at 18 Mths in Infants Who Received hepatitisB Vaccine at Birth & at One Month of Age","Inclusion criteria\n\n* Subjects must have been enrolled in the Rota-028 study.\n* Subjects for whom the investigator believes that their parents\u002Fguardians can and will comply with the requirements of the protocol should be enrolled in the study.\n* A male or female between, and including, 11 and 17 weeks of age at the time of the first vaccination.\n* Written informed consent obtained from the parent or guardian of the subject.\n* Free of obvious health problems as established by medical history and clinical examination before entering into the study.\n* Subjects should have received two doses of hepatitis B vaccine: at birth and at approximately one month of age.\n\nExclusion criteria\n\n* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the study period.\n* Planned administration\u002F administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of the vaccine and ending 30 days after.\n* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.\n* A family history of congenital or hereditary immunodeficiency.\n* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.\n* Major congenital defects or serious chronic illness.\n* History of any neurologic disorders or seizures.\n* Acute disease at the time of enrolment.\n* Administration of immunoglobulins and\u002For any blood products since birth or planned administration during the study period.","ALL","11 Weeks","17 Weeks",{"count":67,"type":68},702,"ACTUAL","INTERVENTIONAL",[71],"PHASE3","To assess the safety and reactogenicity of the DTPa-HBV-IPV\u002FHib vaccine and DTPa-IPV\u002FHib vaccine. This DTPa-IPV\u002FHib vaccine given at 3 and 4 months of age is co-administered with GSK Biologicals' rotavirus vaccine or Placebo. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.",[74,75,76,77,78],"Haemophilus Influenzae Type b","Diphtheria","Tetanus","Poliomyelitis","Acellular Pertussis","COMPLETED","2018-05-02",{"date":82,"type":68},"2018-06-06",{"date":84,"type":27},"2003-12-01",{"date":86,"type":68},"2007-02-01",{"name":5,"class":6},3]