NCT02164110已完成3 期
A Randomized, Single Blind, Multicenter, Therapeutic Confirmatory Study to Assess the Efficacy (Immunogenicity) and Safety of Euvichol in Healthy Adults and Children
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 3,632
- 试验地点
- 1
- 主要终点
- Efficacy
研究概览
简要总结
The purpose of this study is to evaluate the efficacy (Immunogenicity) and Safety of Euvichol in Healthy Adults and Children.
详细描述
A randomized, single blind, multicenter, therapeutic confirmatory study to assess the efficacy (immunogenicity) and safety of Euvichol in healthy adults and children
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
- Single (Participant)
入排标准
- 年龄范围
- 1 Year 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed consent to study participation voluntarily provided by an individual or his/her legally acceptable representative.
- •Age of 1 ~ 40 years
- •An individual who can be followed up during the study period and is capable of complying with the study requirements.
排除标准
- •History of hypersensitivity reactions to other preventative vaccinations.
- •Immune function disorders including immunodeficiency diseases.
- •An individual thought to have difficulty participating in the study due to severe chronic diseases, based on the judgment of the investigator.
- •38℃ or higher body temperature measured prior to investigational product dosing.
- •Abdominal pain, nausea, vomiting, or decreased appetite within 24 hours prior to study initiation.
- •Diarrhea or administration of antidiarrheal drugs or antibiotics to treat diarrhea within 1 week prior to study initiation.
- •Other vaccination within 1 week prior to study initiation or planned vaccination during the study.
- •Diarrhea or abdominal pain lasting 2 weeks or longer within 6 months prior to study initiation.
- •Participation in another clinical trial with investigational product dosing within 1 month prior to study initiation.
- •Pregnant or lactating women.
- •An individual thought to have difficulty participating in the study due to other reasons, based on the judgment of the investigator
- •Applicable to the Pivotal study only: history of cholera vaccinations or history of cholera.
研究组 & 干预措施
Shanchol
Active Comparator
- Number of doses and intervals: two doses/Weeks 0 and 2
- Method of administration: oral administration
- Dose of drug to be administered: 1.5 mL/dose
干预措施: Shanchol (Biological)
Euvichol
Experimental
- Number of doses and intervals: two doses/Weeks 0 and 2
- Method of administration: oral administration
- Dose of drug to be administered: 1.5 mL/dose
干预措施: Euvichol (Biological)
结局指标
主要结局
Efficacy
时间窗: 14 days after second doses
Proportion of subjects exhibiting 4-fold or greater rises in titers of anti-V. cholera O1 antibody, relative to baseline
Safety
时间窗: From first shot to 14 days after second dose
Type and frequency of solicited adverse event type (Day 0 \~ 6), Type and frequency of unsolicited adverse event type (Day 0 \~ Day 28)
次要结局
- Efficacy(14 days after second doses)
- Safety(14 days after second doses)
- Safety(From first shot to 14 days after second dose)
研究者
研究点 (1)
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