Meningococcal Infections
Conditions
Keywords
Meningococcal Vaccines, Vaccines, Conjugate, Bacterial Vaccines, Vaccines, Bacterial Infections, Meningococcal Disease, Neiseriaceae Infections, Gram-Negative Bacterial Infections, Infections, Biological Products
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
Interventions
BIOLOGICALEG-MCV4
single intramuscular dose on Day 0
BIOLOGICALMenveo
single intramuscular dose on Day 0
Sponsors
BMI Korea
EyeGene Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seroresponse | 28 days after the vaccination | * 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 |
Countries
South Korea
Contacts
Primary ContactJooyoung Park
Backup ContactKyung-Hee Lee
Outcome results
None listed