[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"EyeGene Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":53},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":5},"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":21,"type":22},1123,"ESTIMATED","INTERVENTIONAL",[25,26],"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",[29],"Meningococcal Infections",[31,32,33,34,35,36,37,38,39,40],"Meningococcal Vaccines","Vaccines, Conjugate","Bacterial Vaccines","Vaccines","Bacterial Infections","Meningococcal Disease","Neiseriaceae Infections","Gram-Negative Bacterial Infections","Infections","Biological Products","RECRUITING","2025-11-28",{"date":44,"type":45},"2025-12-01","ACTUAL",{"date":47,"type":45},"2025-10-15",{"date":49,"type":22},"2027-06",{"name":51,"class":52},"EyeGene Inc.","OTHER",""]