NCT00498654已完成2 期
A Randomized, Double-Blind, Multi-Center, Placebo-Controlled Dose Ranging Study to Determine the Safety, Reactogenicity and Immunogenicity of a Single Oral Dose Typhoid Fever Vaccine (Ty800) in Healthy Adult Subjects
Avant Immunotherapeutics6 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2007年7月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 6
- 主要终点
- Immunogenicity
研究概览
简要总结
The purpose of this trial is to examine the safety and immunogenicity of Ty800 oral vaccine in healthy adult subjects.
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
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Males or Females aged 18 to 55 years, inclusive
- •Capable of understanding and complying with the protocol requirements and be available for the duration of the protocol
排除标准
- •History of malignancy, immunocompromised conditions or currently receiving immunosuppressive treatment including systemic steroids
- •History of Typhoid Fever infection, vaccination against typhoid fever or participation in a Clinical Trial using S.typhi organism at any time
- •History of travel to a typhoid endemic region within the last 5 years or history of raising a child from an endemic area. Endemic regions are South and East Asia, the Indian Subcontinent, Africa and Central and South America including Mexico
- •History of persistent diarrhea, blood in stool, peptic ulcer disease, or inflammatory bowel disease
- •Allergies or sensitivities to antibiotics, notably quinolones, penicillins, sulfonamides, cefalosporins and chloramphenicol, and components of the buffer solution, notably aspartame.
- •People who are commercial food handlers, day care workers, or health care workers involved in direct patient care. Also people with young children under 2 years of age at home or household contacts who are immunocompromised, pregnant or breast-feeding
结局指标
主要结局
Immunogenicity
时间窗: Baseline through Day 14
Reactogenicity
时间窗: Baseline through Month 1 follow-up
次要结局
- Longterm safety and immunogenicity(Month 1 to 6 post-dosing)
研究者
研究点 (6)
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