Phase 4 Observational Prospective Cohort Study to Assess the Safety of Vivotif at Different Release Titers Among Travelers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 855
- 试验地点
- 1
- 主要终点
- The occurrence of any AE up to two weeks after the scheduled final vaccine dose
研究概览
简要总结
This is a multicenter (at travel clinics), phase 4 observational prospective cohort study in healthy adult male and female travelers for whom typhoid vaccination with Vivotif is recommended, as per standard practice.
详细描述
This is a multicenter (at travel clinics), phase 4 observational prospective cohort study in healthy adult male and female travelers for whom typhoid vaccination with Vivotif is recommended, as per standard practice.
The study will enroll 950 subjects who will be randomized at a ratio of 1:1 into two groups, A and B, of 475 subjects each. Group A will receive 6.9-10.0 x109 CFU/capsule and Group B will receive 4.0-6.8 x109 CFU/capsule, respectively.
All subjects will receive four doses of Vivotif. One dose per subject will be administered on Days 1, 3, 5 and 7.
Investigators, subjects and all personnel involved in running the study will not be aware of the actual release titer associated with the distributed lots. Blinding is maintained using the commercial packaging that does not include the actual value of the release titer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects are male or female aged ≥ 18 years at time of dosing
- •Subjects are travelers attending travelers' vaccination clinics
- •Subjects are eligible for typhoid vaccination, according to standard practice
- •Subjects are expected to be able to provide follow-up information
- •Subjects have an expected travel departure date more than 21 days after enrollment (to enhance follow-up by ensuring subjects remain in the US during the AE collection period)
- •Subjects must sign a written informed consent
排除标准
- •Subjects with a known hypersensitivity to any component of the vaccine or the enteric coated capsule
- •Subjects deficient in their ability to mount a humoral or cell-mediated immune response due to either a congenital or acquired immunodeficient state including treatment with immune-suppressive or antimitotic drugs
- •Subjects with an acute febrile illness
- •Subjects with acute gastrointestinal (GI) illness
- •Subjects who are receiving medications with antibacterial activity (including proguanil) at the time of enrollment
- •Subjects with other contraindications as determined by the site investigator
结局指标
主要结局
The occurrence of any AE up to two weeks after the scheduled final vaccine dose
时间窗: Day 21
次要结局
- The occurrence of any SAE up to two weeks after the scheduled final vaccine dose(Day 21)
- The distribution of unsolicited Adverse Reactions(Day 21)
- The distribution of the solicited Adverse Reactions(Day 21)
- The occurrence of any unsolicited adverse event up to two weeks after the scheduled final vaccine dose(Day 21)