NCT00314041已完成2 期
A Randomized, Double-blind, Controlled, Active Comparator, Phase II Study to Assess the Tolerance and Immunogenicity of Conjugate Meningococcal C (MnCC) Vaccine in Infants When Administered in Conjunction With Primary DTP/Hib Vaccination at 2, 3, and 4 Months of Age.
Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 240 人开始时间: 1997年6月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 主要终点
- Antibody responses to MnCC and concomitant vaccines
研究概览
简要总结
Infant phase: To determine the safety of and production of antibodies by a group C meningococcal conjugate vaccine (MnCC), when given at 2, 3, and 4 months of age with routine vaccines.
Booster phase: To compare the safety of and production of antibodies by MnCC with and without MMR and to compare the antibody response to that produced by a low dose of plain polysaccharide vaccine as a way of investigating immune memory
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
- Double
入排标准
- 年龄范围
- 7 Weeks 至 10 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy infants 7-10 weeks of age eligible to receive routine immunization
排除标准
- 未提供
结局指标
主要结局
Antibody responses to MnCC and concomitant vaccines
次要结局
- Safety and reactogenicity
研究者
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