[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608661":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":34,"centralContacts":35,"locations":44,"responsibleParty":56,"collaborators":58,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":34,"eligibilityCriteria":68,"healthyVolunteers":69,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":34,"studyType":76,"phases":77,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":47,"whyStopped":34,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"EyeGene Inc.","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"EG-MCV4 (Test group 1)","EXPERIMENTAL","Healthy adults received 0.5 mL single intramuscular dose on Day 0.",[13],"Biological: EG-MCV4",{"label":15,"type":10,"description":16,"interventionNames":17},"EG-MCV4 (Test group 2)","Healthy adults received 0.25 mL single intramuscular dose on Day 0.",[13],{"label":19,"type":20,"description":11,"interventionNames":21},"Menveo","ACTIVE_COMPARATOR",[22],"Biological: Menveo",[24,31],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"BIOLOGICAL","EG-MCV4","single intramuscular dose on Day 0",[9,15],[30],"Meningococcal(Groups A, C, W-135, and Y) Conjugate Vaccine",{"type":25,"name":19,"description":27,"armGroupLabels":32,"otherNames":33},[19],[30],null,[36,41],{"name":37,"role":38,"phone":39,"phoneExt":34,"email":40},"Jooyoung Park","CONTACT","+82-2-322-1687","jypark@eyegene.co.kr",{"name":42,"role":38,"phone":39,"phoneExt":34,"email":43},"Kyung-Hee Lee","seagreen@eyegene.co.kr",[45],{"facility":46,"status":47,"city":48,"state":34,"zip":34,"country":49,"countryCode":34,"cosmosGeoPoint":50,"geoPoint":55,"contacts":34},"The Catholic University of Eunpyeong St.Mary's Hospital","RECRUITING","Seoul","South Korea",{"type":51,"coordinates":52},"Point",[53,54],126.9784,37.566,{"lat":54,"lon":53},{"type":57,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR",[59],{"name":60,"class":61},"BMI Korea","INDUSTRY","100608661","phase-2-immunogenicity-and-safety-of-meningococcal-conjugate-vaccine-eg-mcv4-in-healthy-adults-aged-19-to-55-years-old-100608661",false,"NCT07204457","Immunogenicity and Safety of Meningococcal Conjugate Vaccine (EG-MCV4) in Healthy Adults Aged 19 to 55 Years Old","Multicenter, Randomized, Subject\u002FEvaluator Blind, Active Control, Phase II\u002FIII Clinical Trial to Assess Immunogenicity and Safety of EG-MCV4 Meningococcal (Groups A, C, W-135, and Y) Conjugated Vaccines","Inclusion Criteria:\n\n* Healthy males and females aged 19 to 55 years.\n* Individuals who have been fully informed about the clinical trial, understand the details, and voluntarily agree to participate by providing written informed consent.\n* Individuals who are available for all scheduled visits, including phone calls and in-person appointments, for the duration of the study.\n\nExclusion Criteria:\n\n* History of prior disease caused by N. meningitidis.\n* Contact with a person infected with N. meningitidis within 60 days of screening.\n* Prior receipt of a meningococcal vaccine or a vaccine containing a meningococcal antigen.\n* History of or planned vaccination with any other vaccine within 4 weeks before or after administration of the investigational product.\n* History of fever (≥ 38°C) within 3 days of screening, or a history of a significant acute infectious disease within 7 days of screening, or a chronic infectious disease within 4 weeks of screening.\n* History of Hepatitis B or C at the time of screening.\n* Presence of any significant acute, chronic, or progressive disease that, in the opinion of the investigator, could interfere with the conduct or completion of the study.\n* History of malignancy or high-risk malignant disease within 5 years before the investigational product administration.\n* History of epilepsy, progressive neurological disease, or Guillain-Barré Syndrome.\n* History of anaphylaxis.\n* History of systemic urticaria within 5 years of the investigational product administration.\n* Hypersensitivity to the active substance, diphtheria toxoid (CRM197), or any other excipient, or a history of a life-threatening reaction to a vaccine containing similar components.\n* Hypersensitivity to the investigational vaccine, any of its components, or latex.\n* History of any therapy that could affect the immune system within 6 months of screening.\n* History of immunodeficiency disease, or a family history of such a disease.\n* Receipt of any parenteral immunoglobulin preparation, blood product, or plasma derivatives within 90 days of screening, or planned administration during the study period.\n* History of platelet-related or hemorrhagic disorders or a history of excessive bleeding or bruising after intramuscular injection or venipuncture.\n* Current treatment with anticoagulants or new antiplatelet agents.\n* History of organ or bone marrow transplantation.\n* Suspected history of drug or alcohol abuse within 1 year before the investigational product administration.\n* Individuals unwilling to use a medically acceptable method of contraception for the duration of the clinical trial.\n* Pregnant or lactating women.\n* Receipt or planned receipt\u002Fapplication of another investigational drug or medical device within 6 months prior to study participation.\n* Presence of a significant abnormality on a screening test, or any other reason that, in the opinion of the investigator, makes the individual unsuitable for the study.",true,"ALL","19 Years","55 Years",{"count":74,"type":75},1123,"ESTIMATED","INTERVENTIONAL",[78,79],"PHASE2","PHASE3","Phase 2\u002F3 study to evaluate immunogenicity and safety in healthy adult participants following a single dose administration of Meningococcal (groups A, C, W-135, and Y) conjugate vaccine",[82],"Meningococcal Infections",[84,85,86,87,88,89,90,91,92,93],"Meningococcal Vaccines","Vaccines, Conjugate","Bacterial Vaccines","Vaccines","Bacterial Infections","Meningococcal Disease","Neiseriaceae Infections","Gram-Negative Bacterial Infections","Infections","Biological Products","2025-11-28",{"date":96,"type":97},"2025-12-01","ACTUAL",{"date":99,"type":97},"2025-10-15",{"date":101,"type":75},"2027-06",{"name":5,"class":6},1]