Safety of ChimeriVax™ Dengue Tetravalent Vaccine in Adult Subjects Previously Immunised With an Investigational Dengue or Yellow Fever Vaccine
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Safety: To provide information concerning the safety of ChimeriVax™
研究概览
简要总结
To evaluate effect of previous flavivirus exposure on the safety and immunogenicity of the ChimeriVax™ dengue tetravalent vaccine
Primary Objectives:
- To describe the safety of one injection of ChimeriVax™ dengue tetravalent vaccine.
- To describe the immune response against dengue before and after one injection of ChimeriVax™ dengue tetravalent vaccine
详细描述
This study will evaluate a dengue tetravalent vaccine formulation in subjects aged 18 to 40 years and previously immunised with a dengue or YF vaccine.
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
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
Received monovalent Vero dengue vaccine in Study DIV12
干预措施: Chimeric dengue serotype (1, 2, 3, 4) (Biological)
2
Received Yellow fever vaccine in Study DIV12
干预措施: Chimeric dengue serotype (1, 2, 3, 4) (Biological)
3
Flavivirus-naive subjects
干预措施: Chimeric dengue serotype (1, 2, 3, 4) (Biological)
结局指标
主要结局
Safety: To provide information concerning the safety of ChimeriVax™
时间窗: 28 days post-vaccination and entire study duration
Immunogenicity: To provide information concerning the immunogenicity of ChimeriVax™
时间窗: 28, 60 and 180 days post vaccination
次要结局
未报告次要终点