Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2025-12-29 @ 2:32 AM
Study NCT ID:
NCT07204457
Status:
RECRUITING
Last Update Posted:
2025-12-01
First Post:
2025-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunogenicity and Safety of Meningococcal Conjugate Vaccine (EG-MCV4) in Healthy Adults Aged 19 to 55 Years Old
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008589', 'term': 'Meningococcal Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D007239', 'term': 'Infections'}], 'ancestors': [{'id': 'D016870', 'term': 'Neisseriaceae Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018074', 'term': 'Vaccines, Conjugate'}, {'id': 'D022401', 'term': 'Meningococcal Vaccines'}], 'ancestors': [{'id': 'D014614', 'term': 'Vaccines, Synthetic'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D000941', 'term': 'Antigens'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D001428', 'term': 'Bacterial Vaccines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1123}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-28', 'studyFirstSubmitDate': '2025-09-25', 'studyFirstSubmitQcDate': '2025-09-25', 'lastUpdatePostDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Seroresponse', 'timeFrame': '28 days after the vaccination', 'description': '* Part 1:\n\n * The proportion of subjects achieving a seroresponse as measured by hSBA and rSBA\n* Part 2:\n\n * The proportion of subjects achieving a seroresponse as measured by rSBA'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Meningococcal Vaccines', 'Vaccines, Conjugate', 'Bacterial Vaccines', 'Vaccines', 'Bacterial Infections', 'Meningococcal Disease', 'Neiseriaceae Infections', 'Gram-Negative Bacterial Infections', 'Infections', 'Biological Products'], 'conditions': ['Meningococcal Infections']}, 'descriptionModule': {'briefSummary': 'Phase 2/3 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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': '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/application 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.'}, 'identificationModule': {'nctId': 'NCT07204457', 'briefTitle': 'Immunogenicity and Safety of Meningococcal Conjugate Vaccine (EG-MCV4) in Healthy Adults Aged 19 to 55 Years Old', 'organization': {'class': 'OTHER', 'fullName': 'EyeGene Inc.'}, 'officialTitle': 'Multicenter, Randomized, Subject/Evaluator Blind, Active Control, Phase II/III Clinical Trial to Assess Immunogenicity and Safety of EG-MCV4 Meningococcal (Groups A, C, W-135, and Y) Conjugated Vaccines', 'orgStudyIdInfo': {'id': 'EG-MCV4-P3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EG-MCV4 (Test group 1)', 'description': 'Healthy adults received 0.5 mL single intramuscular dose on Day 0.', 'interventionNames': ['Biological: EG-MCV4']}, {'type': 'EXPERIMENTAL', 'label': 'EG-MCV4 (Test group 2)', 'description': 'Healthy adults received 0.25 mL single intramuscular dose on Day 0.', 'interventionNames': ['Biological: EG-MCV4']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Menveo', 'description': 'Healthy adults received 0.5 mL single intramuscular dose on Day 0.', 'interventionNames': ['Biological: Menveo']}], 'interventions': [{'name': 'EG-MCV4', 'type': 'BIOLOGICAL', 'otherNames': ['Meningococcal(Groups A, C, W-135, and Y) Conjugate Vaccine'], 'description': 'single intramuscular dose on Day 0', 'armGroupLabels': ['EG-MCV4 (Test group 1)', 'EG-MCV4 (Test group 2)']}, {'name': 'Menveo', 'type': 'BIOLOGICAL', 'otherNames': ['Meningococcal(Groups A, C, W-135, and Y) Conjugate Vaccine'], 'description': 'single intramuscular dose on Day 0', 'armGroupLabels': ['Menveo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': "The Catholic University of Eunpyeong St.Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Jooyoung Park', 'role': 'CONTACT', 'email': 'jypark@eyegene.co.kr', 'phone': '+82-2-322-1687'}, {'name': 'Kyung-Hee Lee', 'role': 'CONTACT', 'email': 'seagreen@eyegene.co.kr', 'phone': '+82-2-322-1687'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'EyeGene Inc.', 'class': 'OTHER'}, 'collaborators': [{'name': 'BMI Korea', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}