Status:
RECRUITING
Immunogenicity and Safety of Meningococcal Conjugate Vaccine (EG-MCV4) in Healthy Adults Aged 19 to 55 Years Old
Lead Sponsor:
EyeGene Inc.
Collaborating Sponsors:
BMI Korea
Conditions:
Meningococcal Infections
Eligibility:
All Genders
19-55 years
Phase:
PHASE2
PHASE3
Brief Summary
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
Eligibility Criteria
Inclusion
- Healthy males and females aged 19 to 55 years.
- 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
- History of prior disease caused by N. meningitidis.
- 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.
Key Trial Info
Start Date :
October 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
1123 Patients enrolled
Trial Details
Trial ID
NCT07204457
Start Date
October 15 2025
End Date
June 1 2027
Last Update
December 1 2025
Active Locations (1)
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1
The Catholic University of Eunpyeong St.Mary's Hospital
Seoul, South Korea