NCT01040325已完成2 期
A Phase Two, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of the Travelers' Diarrhea Vaccine System in Travelers to Asia
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 723
- 试验地点
- 16
- 主要终点
- Incidence of cases with vaccine preventable outcome
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of the TD Vaccine System to prevent moderate to severe enterotoxin E.coli (ETEC) disease in travelers to India.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-64 years of age at date of first vaccination
- •Good health as determined by medical history and physical inspection
- •Females of child-bearing potential must have a negative pregnancy test prior to first and second vaccination in the country of origin; females of child-bearing potential must agree not to become pregnant throughout the duration of study
- •Subjects must have planned travel to DC, within 3 hours traveling distance of approved study site(s), for a minimum duration of stay of 7 days (no maximum stay is specified for inclusion).
- •Subject must be able to communicate in English
排除标准
- •Abnormalities as determined by the Investigator/clinician during physical inspection;
- •Participated in research involving investigational product within 30 days before planned date of first vaccination;
- •Ever received LT, ETEC, or cholera vaccine;
- •History of diarrhea while traveling in a developing country within the last year;
- •Women who are pregnant or breastfeeding;
- •Clinically significant underlying enteric, pulmonary, cardiac, liver or renal disease;
- •History of Irritable Bowel Syndrome;
- •Seizure disorder within the last year;
- •Current use of immunosuppressive therapy (excluding inhaled steroids) or immunodeficiency;
- •Known or suspected alcohol abuse or illicit drug use within the last year;
- •Medical history of HIV, HBV, or HCV;
- •An employee of a study site;
- •Known allergies to any component of the vaccine, including adhesives;
- •Planned use of antibiotics with known activity against gram negative facultative anaerobes;
- •Planned use of antacids, antidiarrheals, loperamide, bismuth subsalicylate, diphenoxylate or similar from two weeks prior to randomization through the surveillance phase of the study;
- •An employee of Intercell (global) or an immediate family member.
结局指标
主要结局
Incidence of cases with vaccine preventable outcome
时间窗: within 17 days after arrival in destination country
次要结局
- Incidence of moderate/severe diarrhea(within 17 days after arrival in destination country)
研究者
研究点 (16)
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