Study of EG-MCV4 Meningococcal Conjugate Vaccine for Adults Age 19 to 55 Evaluating Immune Response and Safety Compared to Menveo Vaccine

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 23 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 vaccines 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.

Immunogenicity and Safety of Meningococcal Conjugate Vaccine (EG-MCV4) in Healthy Adults Aged 19 to 55 Years Old