[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"meningococcal-infections\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:meningococcal-infections":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,54],{"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":53},"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",1,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":17,"minAge":62,"maxAge":4,"enrollmentInfo":63,"targetDuration":4,"studyType":23,"phases":65,"briefSummary":67,"conditions":68,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":53},"100429726","phase-4-safety-and-immunogenicity-following-meningococcal-and-pneumococcal-immunization-among-adult-people-living-with-hiv-100429726","NCT04875819","Safety and Immunogenicity Following Meningococcal and Pneumococcal Immunization Among Adult People Living With HIV","Safety and Immunogenicity Following Meningococcal and Pneumococcal Immunization Among Adult People Living With HIV: A Single Center, Non-blinded, Randomized Clinical Trial","MENPI","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Seropositive for HIV-1\n* Recipient of ART\n* Plasma HIV-RNA \\\u003C 500 copies\u002Fml\n* Patients written consent obtained\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding\n* History of meningococcal or pneumococcal vaccination\n* Allergies towards any of the vaccine components\n* Temperature \\> 38 ᵒC\n* Sign of bacterial infection\n* Previous known or suspected disease caused by N. meningitidis\n* Active AIDS associated illness\n* Active malignancy\n* End-stage renal or liver disease\n* Bleeding disorder\n* Recipient of any blood, blood products and\u002For plasma derivatives or any parenteral immunoglobulin preparation within the last month\n* Use of immunosuppressive agents (corticosteroids, cancer chemotherapeutic agents etc.)","18 Years",{"count":64,"type":22},55,[66],"PHASE4","MENPI is an investigator-initiated single-centre randomized controlled trial which aims to assess the efficacy and safety of meningococcal and pneumococcal vaccination in adults living with HIV receiving antiretroviral treatment.\n\nParticipants are randomized 1:1 to either a two-dose Menveo® and Bexsero® regimen or a Prevenar13®\u002FPneumovax23® prime-boost regimen at day 0 and day 60 and cross over on day 90. All participants will follow an identical follow up program including plasma collection, pharyngeal swab, and adverse event registration.\n\nImmunogenicity will be determined on venous blood sampled at 30 days post-vaccination and yearly for five years.",[69,29,70],"Hiv","Pneumococcal Infections","2021-05-05",{"date":73,"type":45},"2021-05-06",{"date":75,"type":45},"2021-04-28",{"date":77,"type":22},"2026-12",{"name":79,"class":52},"Thomas Benfield"]