NCT00197808已完成4 期
Response of United Kingdom (UK) Infants to a Reduced Primary Schedule With Meningococcal C and Pneumococcal Conjugate Vaccines
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 392
- 试验地点
- 2
- 主要终点
- Immunogenicity
研究概览
简要总结
The purpose of the study is to evaluate the immune responses of UK infants after one or two doses of pneumococcal conjugate vaccine or one or two doses of three different types of meningococcal conjugate vaccine given at either two and three or two and four months of age.
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
- 7 Weeks 至 11 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed consent obtained from parent or legal guardian of infant
- •Age 7-11 weeks at first dose
排除标准
- •Any contraindications to vaccination as specified in the UK Handbook "Immunisation Against Infectious Disease" (Ed 1996)
- •< 7 weeks or > 11 weeks at first dose
研究组 & 干预措施
Vaccine schedule 2
Experimental
Menjugate vaccine at 2 and 4 months
干预措施: Men C conjugate vaccine (Biological)
vaccine schedule3
Experimental
Neissvacc at 2 and 3 months
干预措施: Men C conjugate (Biological)
vaccine schedule 4
Experimental
Neissvacc at 2 and 4 months
干预措施: Men C Conjugate (Biological)
Vaccine schedule 5
Experimental
Meningitec at 2 and 3 months
干预措施: Men C conjugate (Biological)
Vaccine schedule 6
Experimental
Meningitec at 2 and 4 months
干预措施: Men C conjugate (Biological)
Vaccine schedule 1
Experimental
Menjugate vaccine at 2 and 3 months
干预措施: menjugate (Biological)
结局指标
主要结局
Immunogenicity
时间窗: 3 months after last sample
SBA men C responses
次要结局
未报告次要终点
研究者
研究点 (2)
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