NCT03956524已完成1 期
An Open-label, Comparative, Clinical Phase 1 Study to Assess the Safety and Tolerability of Typhoid Conjugate Vaccine (EuTCV) in Healthy Adults
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Unsolicited adverse events
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of EuTCV, in comparison to TCV (Typbar-TCV™, Bharat Biotech) and Vi-Polysaccharide vaccine (Typhim Vi®, Sanofi Pasteur) in healthy adult volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects aged between and including 18 and 45 years at time of Visit 1
- •Subjects willing to give written informed consent to participate in the trial
- •Subjects who are healthy as determined by medical history, with no clinically significant abnormalities in clinical examination and laboratory tests
排除标准
- •Subjects unwilling to give his/her consent to participate in the trial
- •Subjects who have received Typhoid containing vaccines
- •Subjects who have past history of Typhoid
- •Subjects already immunized with any licensed vaccine within 4 weeks
- •Subjects with known hypersensitivity to any component of the study vaccine
- •Subjects who are pregnant, lactating or childbearing age not using a reliable method of contraception
- •Subjects with any abnormality or chronic disease
- •Subjects with evidence of acute illness within past 7 days requiring systemic antibiotic or antiviral therapy
- •Subjects who have experienced transient thrombocytopenia or neurological complications following an earlier immunization against diphtheria and/or typhoid
- •Subjects who have known history of immune function disorders
- •Subjects who have known history of administration of blood or blood-derived products
- •Subjects who have history of alcohol or substance abuse
结局指标
主要结局
Unsolicited adverse events
时间窗: up to 6 weeks
Local and systemic solicited adverse events
时间窗: Day 7
Serious adverse events
时间窗: up to 6 weeks
次要结局
- Proportion of subjects with seroconversion(Baseline to Day 42)
研究者
研究点 (2)
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