Phase I Study to Determine the Safety and Immunogenicity of Euvichol(Oral Cholera Prevention Vaccine)in Healthy Adult Men ; Open, Non-comparative Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Safety(proportion of subjects with adverse events)
研究概览
简要总结
To Determine the Safety and Immunogenicity of an Oral(Whole Cell) Euvichol Cholera Vaccine in Healthy Adult Men
详细描述
This clinical trial is open, non-comparative phase 1 clinical studies in healthy men and has been designed to determine the safety and immunogenicity of Euvichol(Oral cholera vaccine)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Adult men over 20years of age
- •More than 45kg body weight and ideal body weight within ±20% of the weight
- •Screening was conducted within 14 days of investigational drug administration (Vital Sign & Physical Examination, hematology and blood coagulation tests, blood chemistry tests, urinalysis, 12-lead ECG, etc.), the results at the discretion of the investigator deemed suitable for participation in clinical trials
- •Written consent person who determines to participate in a clinical trial
排除标准
- •A person who showed hypersensitivity when other preventive vaccination in the past
- •A person who have received cholera vaccine in the past
- •A person who had a febrile illness or infection disease, or have received antibiotics within 2weeks before the start of the experiment
- •A person who had gastrointestinal symptoms such as diarrhea, abdominal pain, or have been received prescription drug within one week before the start of the experiment
- •A person who was lasted for more than two weeks of symptoms such as diarrhea, abdominal pain within 6months before the start of the experiment
- •A person who donate whole blood or component of blood within one months before the start of the experiment if the donors
- •A person who received other preventive vaccine within 2months before the start of the experiment
- •A person who received blood products of immune globulin preparations within 3months before the start of the experiment
- •A person who has immune function disorders or are receiving immunosuppressive treatment
- •A person who has chronic illness in progress
- •Ongoing drug and alcohol abuse(Not more than 28 units/week for drinking)
- •A person who participate in clinical trials treated with the investigational drug within 2months before the start of the experiment
- •A person who is difficult to participate in this clinical trials as the discretion of the investigator
研究组 & 干预措施
Euvichol
Euvichol is a homogeneous suspension of inactivated suitable strains of Vibrio cholera serogroup O1 and O139. Euvichol is Yellow to yellowish colour.
干预措施: Euvichol (Biological)
结局指标
主要结局
Safety(proportion of subjects with adverse events)
时间窗: From the date of the first orally administered for 4 weeks after the second dose
The proportion of all adverse event and serious adverse event which were occured during the entire study period is analyzed and casuality between severity and investigational product is presented. Check the vital signs, physical examination and clinical laboratory tests
次要结局
- Immunogenicity(vibriocidal antibody assay)(Baseline(before the administration), 14 days after first dose, 14 days after second dose)