[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100074771":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":12,"centralContacts":7,"locations":16,"responsibleParty":29,"collaborators":7,"id":31,"slug":32,"hasResults":33,"nctId":34,"briefTitle":35,"officialTitle":36,"acronym":7,"eligibilityCriteria":37,"healthyVolunteers":38,"sex":39,"minAge":40,"maxAge":41,"enrollmentInfo":42,"targetDuration":7,"studyType":44,"phases":45,"briefSummary":47,"conditions":48,"keywords":50,"overallStatus":53,"whyStopped":7,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":63,"locationsCount":64},{"fullName":5,"class":6},"GlaxoSmithKline","INDUSTRY",null,[9],{"type":10,"name":11,"description":7,"armGroupLabels":7,"otherNames":7},"BIOLOGICAL","Mencevax ACWY",[13],{"name":14,"affiliation":5,"role":15},"GSK Clinical Trials","STUDY_DIRECTOR",[17],{"facility":18,"status":7,"city":19,"state":7,"zip":20,"country":21,"countryCode":22,"cosmosGeoPoint":23,"geoPoint":28,"contacts":7},"GSK Investigational Site","Beirut","1107-2020","Lebanon","LB",{"type":24,"coordinates":25},"Point",[26,27],35.50157,33.89332,{"lat":27,"lon":26},{"type":30,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100074771","phase-4-assess-the-non-inferiority-of-gsk-biologicals-mencevax-acwy-manufactured-by-a-new-process-vs-mencevax-acwy-the-already-existing-vaccine-in-the-market-when-given-as-a-single-dose-to-subjects-aged-2-30-yrs-100074771",false,"NCT00227422","Assess the Non-inferiority of GSK Biologicals' Mencevax™ ACWY (Manufactured by a New Process) vs Mencevax™ ACWY (the Already Existing Vaccine in the Market) When Given as a Single Dose to Subjects Aged 2-30 Yrs","A Phase IV, Partially Double-blind Study to Demonstrate Non-inferiority of GSK Biologicals' Mencevax™ ACWY (New Process) Versus Mencevax™ ACWY (Current Process) When Administered as a Single Dose to Subjects Aged 2-30 Yrs","Inclusion criteria:\n\n* Healthy male or female between 2 and 30 years of age at the time of vaccination.\n* If the subject is female, she must be of non-childbearing potential. If a subject is a female of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after vaccination.\n\nExclusion criteria:\n\n* Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of study vaccine, or planned use during the study period.\n* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose.\n* Vaccination with a meningococcal vaccine within the last five years.\n* Planned administration\u002F administration of a vaccine not foreseen by the study protocol during the period starting from 15 days before vaccine administration and ending 30 days after.\n* History of or known exposure to meningococcal serogroup A, C, W135 or Y disease or contacts with subjects who had meningococcal disease.\n* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.",true,"ALL","2 Years","30 Years",{"count":43,"type":7},324,"INTERVENTIONAL",[46],"PHASE4","The purpose of this study is to evaluate that the vaccine produced with the new process and administered as a single dose is at least as good as the existing Mencevax™ ACWY vaccine in terms of immunogenicity, safety and reactogenicity, in healthy subjects aged 2-30 years.",[49],"Infections, Meningococcal",[51,52],"Neisseria meningitidis serogroups A & C diseases","Hib diseases","COMPLETED","2016-09-20",{"date":56,"type":57},"2016-09-21","ESTIMATED",{"date":59,"type":7},"2005-06",{"date":61,"type":62},"2005-11","ACTUAL",{"name":5,"class":6},1]