NCT01404962已完成4 期
A Post Marketing Surveillance Study to Monitor the Reactogenicity and Safety of Vaxem™Hib When Administered According to the Prescribing Information in Korea
Novartis Vaccines10 个研究点 分布在 1 个国家目标入组 764 人开始时间: 2011年8月最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 764
- 试验地点
- 10
- 主要终点
- Number of participants with Adverse Events 28 days following vaccination
研究概览
简要总结
This is a multicenter, post marketing surveillance study which aims to evaluate the safety profile of haemophilus influenza type b vaccine when administered to Korean children according to the product insert.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 2 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female children 2 months to 5 years of age scheduled to receive vaccination
排除标准
- •Contraindications to Vaxem™Hib Korean Prescribing information
结局指标
主要结局
Number of participants with Adverse Events 28 days following vaccination
时间窗: 29 days to 5 months
次要结局
未报告次要终点
研究者
研究点 (10)
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