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

Официальное название

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

Обзор

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

Вмешательства

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

Первичные конечные точки

• Seroresponse [Срок оценки: 28 days after the vaccination]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

South Korea · 1 центр

• The Catholic University of Eunpyeong St.Mary's Hospital — Seoul

Идентификаторы

NCT: NCT07204457 · EG-MCV4-P3

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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