Actively Recruiting
Immunogenicity and Safety of Meningococcal Conjugate Vaccine (EG-MCV4) in Healthy Adults Aged 19 to 55 Years Old
Led by EyeGene Inc. · Updated on 2025-12-01
1123
Participants Needed
1
Research Sites
84 weeks
Total Duration
On this page
Sponsors
E
EyeGene Inc.
Lead Sponsor
B
BMI Korea
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Immunogenicity and Safety of Meningococcal Conjugate Vaccine (EG-MCV4) in Healthy Adults Aged 19 to 55 Years Old
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy males and females aged 19 to 55 years
- Fully informed and voluntarily agree to participate by providing written consent
- Available for all scheduled visits, including phone calls and in-person appointments, for the study duration
You will not qualify if you...
- History of meningococcal disease
- Contact with infected person within 60 days before screening
- Previous meningococcal or meningococcal antigen-containing vaccine
- Vaccination with any other vaccine within 4 weeks before or after study vaccine
- Fever ≥ 38°C within 3 days before screening or recent acute or chronic infections
- History of Hepatitis B or C at screening
- Significant acute, chronic, or progressive diseases affecting study participation
- Malignancy or high-risk cancer within 5 years before vaccine
- History of epilepsy, progressive neurological disease, or Guillain-Barré Syndrome
- History of anaphylaxis or systemic urticaria within 5 years
- Hypersensitivity to vaccine components or latex
- Immune system affecting therapy within 6 months before screening
- Immunodeficiency or family history of such
- Receipt of immunoglobulin, blood products, or plasma within 90 days before screening
- Platelet or bleeding disorders or excessive bleeding after injections
- Current anticoagulant or new antiplatelet treatment
- Organ or bone marrow transplantation history
- Suspected drug or alcohol abuse within 1 year before vaccine
- Unwillingness to use medically acceptable contraception during trial
- Pregnant or lactating women
- Receipt or planned receipt of investigational drug or device within 6 months before study
- Significant abnormalities on screening tests or other investigator-determined unsuitability
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Catholic University of Eunpyeong St.Mary's Hospital
Seoul, South Korea
Actively Recruiting
Research Team
J
Jooyoung Park
CONTACT
K
Kyung-Hee Lee
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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