NCT01761136已完成4 期
Phase 4 Study of Haemophilus Influenzae Type b Vaccine in Different Injection Site
Beijing Center for Disease Control and Prevention5 个研究点 分布在 1 个国家目标入组 680 人开始时间: 2011年11月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 680
- 试验地点
- 5
- 主要终点
- Incidence rate of adverse events of Haemophilus influenzae type b vaccine in different injection site
研究概览
简要总结
The objective of this study was to evaluate the safety and immunogenicity of Haemophilus influenzae type b vaccine in different injection site.
详细描述
A randomized trial was conducted in 680 healthy infants with Hib vaccine of two brands. The different sub-groups were selected randomly based on the plan to inoculate vaccines in the upper arm deltoid or vastus lateralis muscle. The safety and immunogenicity were assessed after three or two doses.
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
- 2 Months 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •participants were under 1 years old, and were in good healthy
- •participants were full-time pregnancy and birth weight were more than 2.5 kg
排除标准
- •current infectious fever or acute disease
- •a history of hypersensitivity to study vaccine components especially tetanus toxoid
- •a history of allergy, autoimmune, convulsions, seizures heredity disease
- •a history of Hib vaccination or Hib disease
- •a history of congenital deformity, developmental disorders or serious chronic diseases, muscle injection contradiction, and immunosuppressive agents, hormone or immunoglobulin received.
结局指标
主要结局
Incidence rate of adverse events of Haemophilus influenzae type b vaccine in different injection site
时间窗: one year
次要结局
- Antibody titre of Haemophilus influenzae type b vaccine in different injection site(one year)
研究者
研究点 (5)
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