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

NCT07204457 | Recruiting Phase 2 DMC

• 1 other identifier: EG-MCV4-P3
• Study Type: interventional
• Target: 1,123
• Locations: 1 country
• Sites: 1

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

Conditions

Meningococcal Infections

Keywords

Meningococcal Vaccines; Vaccines, Conjugate; Bacterial Vaccines; Vaccines; Bacterial Infections; Meningococcal Disease; Neiseriaceae Infections; Gram-Negative Bacterial Infections; Infections; Biological Products

Outcome Measures

Primary Outcomes (1)

• 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

  28 days after the vaccination

Study Arms (3)

EG-MCV4 (Test group 1)

EXPERIMENTAL

Healthy adults received 0.5 mL single intramuscular dose on Day 0.

Biological: EG-MCV4

EG-MCV4 (Test group 2)

EXPERIMENTAL

Healthy adults received 0.25 mL single intramuscular dose on Day 0.

Biological: EG-MCV4

Menveo

ACTIVE COMPARATOR

Healthy adults received 0.5 mL single intramuscular dose on Day 0.

Biological: Menveo

Interventions

EG-MCV4 BIOLOGICAL

single intramuscular dose on Day 0

Also known as: Meningococcal(Groups A, C, W-135, and Y) Conjugate Vaccine

EG-MCV4 (Test group 1); EG-MCV4 (Test group 2)

Menveo BIOLOGICAL

single intramuscular dose on Day 0

Also known as: Meningococcal(Groups A, C, W-135, and Y) Conjugate Vaccine

Menveo

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• EyeGene Inc.: lead
• BMI Korea: collaborator

Study Sites (1)

The Catholic University of Eunpyeong St.Mary's Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Meningococcal Infections; Bacterial Infections; Gram-Negative Bacterial Infections; Infections

Interventions

Vaccines, Conjugate; Meningococcal Vaccines

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Bacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

Vaccines, Synthetic; Vaccines; Biological Products; Complex Mixtures; Antigens; Biological Factors; Bacterial Vaccines

Central Study Contacts

Jooyoung Park

CONTACT

+82-2-322-1687; jypark@eyegene.co.kr

Kyung-Hee Lee

CONTACT

+82-2-322-1687; seagreen@eyegene.co.kr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2025
• First Posted: October 2, 2025
• Study Start: October 15, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)