EUCTR2008-008726-75-GB进行中（未招募）不适用
A Phase Three, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of the Travelers’ Diarrhea Vaccine System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 2,400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •A subject may be included in the study if he/she meets all of the following inclusion criteria:
- •1.18-64 years of age at date of first vaccination
- •2.Good health as determined by medical history and physical inspection
- •3.Females of child-bearing potential must have a negative pregnancy test prior to first and second vaccination in the country of origin; females of childbearing potential must agree not to become pregnant throughout the duration of study
- •4.Subjects must have planned travel to an area within 3 hours traveling distance of Mexico City, Cuernavaca, Guadalajara, Oaxaca, or San Miguel de Allende, Mexico or Antigua, Quetzaltenango, Guatemala City, or Solola, Guatemala for a minimum duration of stay of 7 days (no maximum stay is specified for inclusion)
- •5.Subject must be able to communicate in English
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •A subject meeting any of the following criteria during the screening period is not eligible for participation in the study:
- •1.Abnormalities as determined by the Investigator/clinician during physical inspection;
- •2.Participated in research involving investigational product within 30 days before planned date of first vaccination;
- •3.Ever received LT, ETEC, or cholera vaccine;
- •4.History of diarrhea while traveling in a developing country within the last year;
- •5.Women who are pregnant or breastfeeding;
- •6.Clinically significant underlying enteric, pulmonary, cardiac, liver or renal disease;
- •7.History of Irritable Bowel Syndrome;
- •8.Seizure disorder within the last year;
- •9.Current use of immunosuppressive therapy (excluding inhaled steroids) or immunodeficiency;
- •10.Known or suspected alcohol abuse or illicit drug use within the last year;
- •11.Medical history of HIV, HBV, or HCV;
- •12.An employee of a study site;
- •13.Known allergies to any component of the vaccine, including adhesives;
- •14.Planned use of antibiotics with known activity against gram negative facultative anaerobes;
- •15.Planned use of antacids, antidiarrheals, loperamide, bismuth subsalicylate, diphenoxylate or similar from two weeks prior to randomization through the surveillance phase of the study.
- •16. An employee of Intercell (global) or an immediate family member.
研究者
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