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
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.
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.
Parallel
EG-MCV4
Biological/Vaccinesingle intramuscular dose on Day 0
Menveo
Biological/Vaccinesingle intramuscular dose on Day 0
Seroresponse
* Part 1: * The proportion of subjects achieving a seroresponse as measured by hSBA and rSBA * Part 2: * The proportion of subjects achieving a seroresponse as measured by rSBA
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EyeGene Inc.
Lead sponsor
BMI Korea
Collaborator
