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Recruiting NCT07204457

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

Phase II / Phase III Interventional Meningococcal Infections

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: EG-MCV4, Menveo.
Who it may be relevant to
Registry conditions: Meningococcal Infections. Basic parameters: 19 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Multicenter, Randomized, Subject/Evaluator Blind, Active Control, Phase II/III Clinical Trial to Assess Immunogenicity and Safety of EG-MCV4 Meningococcal (Groups A, C, W-135, and Y) Conjugated Vaccines

Overview

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

Interventions

  • Biological EG-MCV4
    single intramuscular dose on Day 0
  • Biological Menveo
    single intramuscular dose on Day 0

Primary outcome measures

  • Seroresponse [Time frame: 28 days after the vaccination]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • Receipt of any parenteral immunoglobulin preparation, blood product, or plasma derivatives within 90 days of screening, or planned administration during the study period.
  • History of platelet-related or hemorrhagic disorders or a history of excessive bleeding or bruising after intramuscular injection or venipuncture.
  • Current treatment with anticoagulants or new antiplatelet agents.
  • History of organ or bone marrow transplantation.
  • Suspected history of drug or alcohol abuse within 1 year before the investigational product administration.
  • Individuals unwilling to use a medically acceptable method of contraception for the duration of the clinical trial.
  • Pregnant or lactating women.
  • Receipt or planned receipt/application of another investigational drug or medical device within 6 months prior to study participation.
  • Presence of a significant abnormality on a screening test, or any other reason that, in the opinion of the investigator, makes the individual unsuitable for the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

South Korea · 1 center
  • The Catholic University of Eunpyeong St.Mary's Hospital — Seoul

Identifiers

NCT: NCT07204457 · EG-MCV4-P3

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗