NCT00262015Unknown4 期
A Phase IV, Single Center, Open-Label, Controlled, Randomized Study to Evaluate the Memory Response of Children Previously Vaccinated With Chiron Meningococcal C Conjugate Vaccine, Menjugate® and Describe the Kinetic of the Antibody Response and Maturation on Days 2-7 and 28 After Challenge With Pasteur Merieux Meningococcal A/C Polysaccharide Vaccine or Menjugate®
适应症
试验速览
- 阶段
- 4 期
- 入组人数
- 264
- 试验地点
- 2
- 主要终点
- To measure immunological memory response to N. meningitidis serogroup C after those who received a partial dose of Meningococcal A/C Polysaccharide vaccine and in subjects who received a dose of Chiron Meningococcal C conjugate vaccine.
研究概览
简要总结
The purpose of this study is to determine when a memory immune response after re-vaccination with Meningococcal C conjugate vaccine (Menjugate) or challenge with Meningococcal A/C polysaccharide vaccine can be observed, after initial vaccination with Meningococcal C conjugate vaccine during the UK immunization campaign
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
- 13 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy adolescents between and including 13-15 years of age, who provide written informed consent and who received one immunization with Chiron Meningococcal C Conjugate vaccine (Menjugate) during the UK immunization campaign and for which documentation can be provided.
排除标准
- •Subjects with a previous or suspected disease caused by N. meningitidis; or previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s); Any serious acute, chronic or progressive disease
结局指标
主要结局
To measure immunological memory response to N. meningitidis serogroup C after those who received a partial dose of Meningococcal A/C Polysaccharide vaccine and in subjects who received a dose of Chiron Meningococcal C conjugate vaccine.
次要结局
- To assess the immunological response to N. meningitidis serogroup C in those challenged with meningococcal A/C polysaccharide vaccine and in those who received a dose of Chiron Meningococcal C conjugate vaccine.
研究者
研究点 (2)
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