NCT01125527已完成3 期
A Phase III Observer-blind, Randomized, Controlled, Single-coordinating Center Study to Investigate Immunogenicity and Safety of a Monovalent Glycoprotein-conjugated (Diptheria Toxin -CRM197) Hib Vaccine in 13-59 Months Old Healthy Children in China, According to the Recommended Regimen of 1 Dose
Novartis Vaccines1 个研究点 分布在 1 个国家目标入组 700 人开始时间: 2009年8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
- 700
- 试验地点
- 1
- 主要终点
- Anti-PRP 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 single dose of two commercially available vaccines used to prevent Haemophilus influenzae type b infections in children 13-59 months 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
- 13 Months 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants 13-59 months of age.
排除标准
- •Prior Hib vaccine administration.
- •History of serious reaction(s) following vaccination.
- •Any vaccination within 7 days of study vaccination.
- •Known or suspected immune impairment.
- •Premature (before 37th week of gestation) or birth weight less than 2500g
- •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 last vaccination
时间窗: 30 days after last vaccination
次要结局
- Solicited local and systemic reactions, AEs, and SAEs(30 days post last vaccination)
研究者
研究点 (1)
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