NCT00316654已完成4 期
A Phase IV,Multi-Center,Open-Label,Unrandomized Study to Evaluate the Persistence of Antibody Response to N.Meningitidis Group C,Before & After 2 Doses of the Conjugate Pneumococcal Vaccine,in Children Seven Months & Older Who Previously Received Immunization With Chiron Meningococcal C Conjugate Vaccine & a Hexavalent Infant Vaccine According to the Applicable Infant Immunization Schedule
Novartis Vaccines2 个研究点 分布在 2 个国家目标入组 489 人开始时间: 2005年2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
- 489
- 试验地点
- 2
- 主要终点
- Immunogenicity: serum antibody responses, as measured by bactericidal activity,using hBCA
研究概览
简要总结
Persistence of Antibody Response to N. meningitidis Group C in Children
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
- 7 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy children
排除标准
- •previous ascertained or suspected disease caused by N. meningitidis
- •previous significant acute or chronic infections
- •any other serious disease
结局指标
主要结局
Immunogenicity: serum antibody responses, as measured by bactericidal activity,using hBCA
次要结局
- Evaluate and compare persistence of antibody response to N. meningitidis serogroup C as measured by serum bactericidal activity
- safety and tolerability
研究者
研究点 (2)
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