NCT00345319已完成3 期
Evaluate the Immunogenicity and Safety of Rabies Vaccine Given in a Post-exposure Prophylaxis Regimen to Healthy Children and Adults Aged 10-60 Years.
Novartis Vaccines1 个研究点 分布在 1 个国家目标入组 630 人开始时间: 2006年3月最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 630
- 试验地点
- 1
- 主要终点
- serum bactericidal activity
研究概览
简要总结
Evaluate the immunogenicity and safety of rabies vaccine given in a post-exposure prophylaxis regimen to healthy children and adults aged 10-60 years.
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 (Participant)
入排标准
- 年龄范围
- 10 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •male and female healthy subjects aged 10-60 years old
排除标准
- •history of rabies immunization
- •previous exposure to a suspect rabid animal within the last 12 months
- •any significant acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the past 7 days
- •treatment with corticosteroids, immunosuppressive or anti-malaria drugs during the two month period before enrollment
- •known/suspected immunodeficiency, or autoimmune disease, or any immunologic disorder
- •known hypersensitivity to neomycin, tetracycline, amphotericin-B, or any other vaccine component
结局指标
主要结局
serum bactericidal activity
时间窗: measured at day 14 and day 45 after first vaccination dose
次要结局
- solicited local and systemic reactions(within 6 days following vaccination and adverse events thought the study)
研究者
研究点 (1)
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