NCT01226953已完成3 期
A Phase III Observer Blind Single-Coordinating Center Pediatric Study in China Comparing a Booster Dose of Vaxem™ Hib to HIBERIX® When Given as Part of a Local Dosing Regimen in Infants
Novartis Vaccines1 个研究点 分布在 1 个国家目标入组 660 人开始时间: 2010年10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
- 660
- 试验地点
- 1
- 主要终点
- Anti-PRP (polyribosyl-ribitol-phosphate) antibody levels at day 31 post last vaccination
研究概览
简要总结
This study will evaluate the safety and immunogenicity of booster dose of two commercially available vaccines used to prevent Haemophilus influenzae type b infections in children 365-569 days of age
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
- 365 Days 至 569 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants 365-569 days of age.
排除标准
- •Subjects who already received a booster dose of Hib vaccine.
- •History of serious reaction(s) following vaccination.
- •Any vaccination within 7 days of study vaccination.
- •Known or suspected immune impairment.
结局指标
主要结局
Anti-PRP (polyribosyl-ribitol-phosphate) antibody levels at day 31 post last vaccination
时间窗: 30 days after last vaccination
次要结局
- Solicited local and systemic reactions, adverse events (AEs), and serious adverse events (SAEs)(30 days post last vaccination)
研究者
研究点 (1)
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