NCT07204457招募中2 期
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
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- EyeGene Inc.
- 入组人数
- 1,123
- 试验地点
- 1
- 主要终点
- Seroresponse
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
EG-MCV4 (Test group 1)
Experimental
Healthy adults received 0.5 mL single intramuscular dose on Day 0.
干预措施: EG-MCV4 (Biological)
EG-MCV4 (Test group 2)
Experimental
Healthy adults received 0.25 mL single intramuscular dose on Day 0.
干预措施: EG-MCV4 (Biological)
Menveo
Active Comparator
Healthy adults received 0.5 mL single intramuscular dose on Day 0.
干预措施: Menveo (Biological)
结局指标
主要结局
Seroresponse
时间窗: 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
次要结局
未报告次要终点
研究者
研究点 (1)
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