NCT00310687已完成4 期
A Phase IV, Single Centre, Open-label Study to Evaluate the Persistence of Antibodies in Adolescents 14-16 Years of Age, Vaccinated With Chiron Meningococcal C Conjugate Vaccine During the 1999-2001 UK MenCC Immunization Campaign, at One Year After Either a Challenge Dose of Aventis Pasteur MSD Meningococcal A/C Polysaccharide Vaccine or a Booster Dose of MenC Vaccine, in Parallel to Subjects Aged 11-20 Evaluated at 4 Years After Vaccination During the 1999-2001 UK MenCC Immunization Campaign
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 1,244
- 试验地点
- 2
- 主要终点
- persistence of memory response to N. meningitidis serogroup C as measured by serum bactericidal activity at one year after either a challenge with 1/5 of a dose of Meningococcal A/C Polysaccharide vaccine or a booster dose of MenC Vaccine.
研究概览
简要总结
Persistence of Immune response after vaccination with MCC
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 11 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy adolescents vaccinated with Meningococcal C Conjugate vaccine
排除标准
- •ascertained or suspected disease caused by N. meningitidis
- •household contact with individuals with proven N. meningitidis serogroup C infection
- •significant acute or chronic infections
- •any other serious disease
结局指标
主要结局
persistence of memory response to N. meningitidis serogroup C as measured by serum bactericidal activity at one year after either a challenge with 1/5 of a dose of Meningococcal A/C Polysaccharide vaccine or a booster dose of MenC Vaccine.
次要结局
- Evaluation of the immunological response (ELISA) to N. meningitidis serogroup C
- Evaluation and comparison of the persistence of antibodies against N. meningitidis serogroup C as measured by hBCA
研究者
研究点 (2)
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