Immunogenicity and Safety of Meningococcal Conjugate Vaccine (EG-MCV4) in Healthy Adults Aged 19 to 55 Years Old
NCT ID: NCT07204457
Last Updated: 2025-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
1123 participants
INTERVENTIONAL
2025-10-15
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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EG-MCV4 (Test group 1)
Healthy adults received 0.5 mL single intramuscular dose on Day 0.
EG-MCV4
single intramuscular dose on Day 0
EG-MCV4 (Test group 2)
Healthy adults received 0.25 mL single intramuscular dose on Day 0.
EG-MCV4
single intramuscular dose on Day 0
Menveo
Healthy adults received 0.5 mL single intramuscular dose on Day 0.
Menveo
single intramuscular dose on Day 0
Interventions
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EG-MCV4
single intramuscular dose on Day 0
Menveo
single intramuscular dose on Day 0
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Individuals who have been fully informed about the clinical trial, understand the details, and voluntarily agree to participate by providing written informed consent.
* Individuals who are available for all scheduled visits, including phone calls and in-person appointments, for the duration of the study.
Exclusion Criteria
* Contact with a person infected with N. meningitidis within 60 days of screening.
* Prior receipt of a meningococcal vaccine or a vaccine containing a meningococcal antigen.
* History of or planned vaccination with any other vaccine within 4 weeks before or after administration of the investigational product.
* 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.
* History of Hepatitis B or C at the time of screening.
* 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.
* History of malignancy or high-risk malignant disease within 5 years before the investigational product administration.
* History of epilepsy, progressive neurological disease, or Guillain-Barré Syndrome.
* History of anaphylaxis.
* History of systemic urticaria within 5 years of the investigational product administration.
* 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.
* Hypersensitivity to the investigational vaccine, any of its components, or latex.
* History of any therapy that could affect the immune system within 6 months of screening.
* History of immunodeficiency disease, or a family history of such a disease.
* Receipt of any parenteral immunoglobulin preparation, blood product, or plasma derivatives within 90 days of screening, or planned administration during the study period.
* History of platelet-related or hemorrhagic disorders or a history of excessive bleeding or bruising after intramuscular injection or venipuncture.
* Current treatment with anticoagulants or new antiplatelet agents.
* History of organ or bone marrow transplantation.
* Suspected history of drug or alcohol abuse within 1 year before the investigational product administration.
* Individuals unwilling to use a medically acceptable method of contraception for the duration of the clinical trial.
* Pregnant or lactating women.
* Receipt or planned receipt/application of another investigational drug or medical device within 6 months prior to study participation.
* 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.
19 Years
55 Years
ALL
Yes
Sponsors
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BMI Korea
INDUSTRY
EyeGene Inc.
OTHER
Responsible Party
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Locations
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The Catholic University of Eunpyeong St.Mary's Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Other Identifiers
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EG-MCV4-P3
Identifier Type: -
Identifier Source: org_study_id
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