NCT01025544已完成3 期
A Phase III Open Label, Multi-Center Pediatric Study in China Comparing Booster Doses of Vaxem Hib and Hiberix Vaccines for the Prevention of Haemophilus Influenzae Type b (Hib) Infection
Novartis Vaccines1 个研究点 分布在 1 个国家目标入组 846 人开始时间: 2009年9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
- 846
- 试验地点
- 1
- 主要终点
- Anti-PRP antibody levels at day 31 post booster
研究概览
简要总结
This study will evaluate the safety and immunogenicity of booster doses of the two vaccines used to prevent Haemophilus influenzae type b infections in children 12-18 months of age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 12 Months 至 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Toddlers 12-18 months of age who have previously participated in study M37P2.
排除标准
- •Prior Hib booster administration.
- •History of serious reaction(s) following vaccination.
- •Vaccination within 14 days of study vaccination.
- •Known or suspected immune impairment.
- •For additional entry criteria please refer to the protocol.
结局指标
主要结局
Anti-PRP antibody levels at day 31 post booster
时间窗: 31 days after vaccination
次要结局
- Solicited local and systemic reactions, AEs, and SAEs(30 days post vaccination)
研究者
研究点 (1)
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