NCT00310635已完成4 期
A Phase IV, Multi-Center, Controlled Open-Label Study to Evaluate the Safety, Tolerability and Immunogenicity of a Commercially Available Meningococcal C Vaccine When Given as First, Third or Fourth Immunization to Children 32-40 Months of Age
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 241
- 试验地点
- 2
- 主要终点
- Determination of memory antibody response to Neisseria meningitidis serogroup C after 2 or 3 doses of MenC vaccine given during infancy, as measured by hBCA at day 0 and day 28.
研究概览
简要总结
Safety, Tolerability and Immunogenicity of Meningococcal C Conjugate Vaccine to Children 32 to 40 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
- 32 Months 至 40 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy children
排除标准
- •known hypersensitivity to any vaccine component
- •significant acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the past 14 days
- •ascertained or suspected disease caused by N. meningitidis
- •household contact with or intimate exposure to an individual with a positive culture of N. meningitidis serogroup C within the previous 60 days
结局指标
主要结局
Determination of memory antibody response to Neisseria meningitidis serogroup C after 2 or 3 doses of MenC vaccine given during infancy, as measured by hBCA at day 0 and day 28.
次要结局
- Determination of antibody titers in naïve control subjects.
- Determination of persistence of antibody response after either 2 or 3 doses of MenC vaccine given during infancy and one dose of MenPS A/C vaccine given at 12 months of age.
- Evaluation of the safety and tolerability of a single 0.5 mL intramuscular (IM) injection of MenC Vaccine when given to children approximately three years of age.
研究者
研究点 (2)
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