NCT00948272已完成2 期
Immunogenicity of the Purified Vero Rabies Vaccine - Serum Free in Comparison With the Reference Purified Vero Rabies Vaccine in Pre-exposure Use in Healthy Adults
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 384
- 试验地点
- 6
- 主要终点
- To provide information concerning the immunogenicity of Purified Vero Rabies Vaccine.
研究概览
简要总结
The purpose of this study is to generate data in human on immunogenicity and safety of Purified Vero Rabies Vaccine (VRVg) in support of the vaccine registration.
Primary Objective:
- To demonstrate that VRVg is at least as immunogenic as the reference vaccine, Verorab, in terms of seroconversion rate at Day 42 of the primary vaccination series.
Secondary Objectives:
- To assess the clinical safety of VRVg after each vaccination when administered in a pre-exposure vaccination schedule with a booster at 12 months after the first vaccination in all subjects.
- To describe the immune response induced by VRVg 21 days after two vaccinations in a subset of randomized subjects and 14 days after the last vaccination of the primary vaccination series.
详细描述
All subjects will receive three vaccinations for primary series and a booster vaccination at 12 months after the first vaccination.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 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
结局指标
主要结局
To provide information concerning the immunogenicity of Purified Vero Rabies Vaccine.
时间窗: 42 days post-primary series vaccination
次要结局
- To provide information concerning the safety after Purified Vero Rabies Vaccine.(0 to 7 days post-vaccination and entire study duration)
研究者
研究点 (6)
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