NCT00581620已完成4 期
To Evaluate the Humoral Immune Response to a Conjugated Pneumococcus Vaccine 7-Valent (Prevenar®) in Children From High Risk Groups.
Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 160 人开始时间: 2002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
- 160
- 主要终点
- To determine immunogenicity of the heptavalent CRM197 pneumococcal conjugate in children with immunodeficiency condition
研究概览
简要总结
To determine immunogenicity of the heptavalent CRM197 pneumococcal conjugate in children with immunodeficiency condition. To evaluate tolerability of Prevenar® in that population.
详细描述
This study will require 24 months to be completed. Each child will participate for a period of time according to age of the 1st dose of vaccination: infants up to 6 months of age will be evaluated for 5 months; infants between 7 to 11 months will be evaluated for 3 months; children between 12 months up to 9 years of age will be evaluate for 2 months
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 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children between 2 months to 9 years old.
- •Children with HIV+; Sickle Cell disease; Neprotic symdrome; Chronic pulmonary disease
- •No history of seizures
排除标准
- 未提供
结局指标
主要结局
To determine immunogenicity of the heptavalent CRM197 pneumococcal conjugate in children with immunodeficiency condition
时间窗: 4 months
次要结局
- To evaluate tolerability of Prevenar* in that population.(4 months)
研究者
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