NCT00993681已完成3 期
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
- 3 期
- 状态
- 已完成
- 入组人数
- 2,036
- 试验地点
- 40
- 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 Travelers' Diarrhea Vaccine System to actively immunize against Enterotoxigenic Escherichia coli disease in a field setting.
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 vaccination in teh Country of Origin; females of child-bearing potential must agree not to become pregnant throughout the duration of the study
- •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, Quezaltenango, Guatemala City, or Solola, Guatemala for a minimum duration of stay 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 to 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 current 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 during 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: Day 17 (17 days after arrival in destination country)
次要结局
- The incidence of moderate/severe diarrhea(Day 17 (17 days after arrival in destination country))
- Total unformed stool frequency from diarrheal episodes(Day 17 (17 days after arrival in destination country))
- Total duration of diarrheal episodes(Day 17 (17 days after arrival in destination country))
研究者
研究点 (40)
Loading locations...
相似试验
已完成
2 期
Traveler's Diarrhea (TD) Vaccine Asia Efficacy StudyTraveler's DiarrheaNCT01040325Intercell USA, Inc.723
已完成
3 期
Efficacy, Safety and Immunogenicity of Takeda's Tetravalent Dengue Vaccine (TDV) in Healthy ChildrenHealthy VolunteersNCT02747927Takeda20,099
已完成
3 期
A Phase 3b, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of Select Travel Vaccines When Administered Concomitantly With MenACWY in AdultsMeningococcal DiseaseTyphoidJapanese EncephalitisMeningococcal MeningitisYellow FeverRabiesNCT01466387Novartis552
已完成
3 期
Safety and Immunogenicity of 20vPnC in Toddlers With 2 Prior Doses of Prevenar 13Pneumococcal DiseaseNCT05408429Pfizer356
已完成
1 期
Safety Study of HBV DNA Vaccine to Treat Patients With Chronic Hepatitis B InfectionChronic Hepatitis BNCT00277576PowderMed48