Actively Recruiting
Multicenter, Randomized, Double-Blind, Active-Controlled Phase II/III Trial to Assess Immunogenicity and Safety of EG-MCV4 Meningococcal Conjugate Vaccine in Adults Aged 19 to 55
Led by EyeGene Inc. · Updated on 2025-12-01
1123
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
Sponsors
E
EyeGene Inc.
Lead Sponsor
B
BMI Korea
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the immune response and safety of a meningococcal conjugate vaccine targeting groups A, C, W-135, and Y in healthy adults aged 19 to 55 years. This phase 2/3 study aims to better understand how the vaccine triggers immunity and its safety profile when given as a single dose. The research is sponsored by EyeGene Inc. and involves comparing different doses of the investigational vaccine with an active comparator vaccine. Participants receive a single intramuscular dose of either 0.5 mL or 0.25 mL of the investigational vaccine (EG-MCV4) or 0.5 mL of the active comparator vaccine (Menveo) on Day 0. The study is randomized and double-blind, meaning neither participants nor evaluators know which vaccine is administered. The different dose groups and the active comparator help assess the vaccine's immunogenicity and safety. During the study, participants attend scheduled visits and phone calls to monitor their health and immune response. Researchers measure the primary outcome of seroresponse 28 days after vaccination to assess immunity. Safety is closely observed throughout the trial. Participants must be available for all study visits, and the total duration covers the vaccination day through the follow-up assessments leading up to the 28-day immune response evaluation.
CONDITIONS
Brief 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 about the trial and voluntarily agree to participate with 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 disease caused by Neisseria meningitidis
- Contact with someone infected with Neisseria meningitidis within 60 days before screening
- Prior meningococcal vaccine or vaccine containing meningococcal antigen
- 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 infectious disease
- History of Hepatitis B or C at screening
- Significant acute, chronic, or progressive disease interfering with study participation
- History of malignancy or high-risk malignant disease within 5 years before vaccination
- History of epilepsy, progressive neurological disease, or Guillain-Barré Syndrome
- History of anaphylaxis or systemic urticaria within 5 years before vaccination
- Hypersensitivity to active substances, diphtheria toxoid (CRM197), excipients, or latex
- Therapy affecting immune system within 6 months before screening
- History or family history of immunodeficiency disease
- Receipt of immunoglobulin, blood products, or plasma derivatives within 90 days before screening
- History of bleeding disorders or excessive bleeding after injections or venipuncture
- Current treatment with anticoagulants or new antiplatelet agents
- History of organ or bone marrow transplant
- Suspected drug or alcohol abuse within 1 year before vaccination
- Unwillingness to use medically acceptable contraception during the trial
- Pregnant or lactating women
- Receipt or planned receipt of another investigational drug or device within 6 months prior
- Significant abnormality on screening test or other investigator-determined unsuitability for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive a single intramuscular dose of the meningococcal conjugate vaccine on Day 0.
1 vaccination visit (in-person)
Duration - 28 days
Participants are monitored for immunogenicity and safety outcomes after vaccination.
1 follow-up visit (in-person) around 28 days after vaccination
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
K
Kyung-Hee Lee
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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