NCT00387569已完成1 期
A Randomized, Observer-Blinded, Parallel-Group, Active-Control, Phase 1/2 Trial of the Safety, Immunogenicity, and Tolerability of 20 µg, 60 µg, and 200 µg of Meningococcal Group B rLP2086 Vaccine in Healthy Adolescents Aged 10 to 12 Years
Wyeth is now a wholly owned subsidiary of Pfizer1 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2006年10月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Local and systemic reactions through 14 days post-injection; Vaccinations at 0,1,6 months
研究概览
简要总结
A study to assess the safety of an investigational meningitis vaccine in toddlers and their immune response to it.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Months 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18- to 36-months
- •Healthy male or female subjects
排除标准
- •Prior vaccination with a serogroup B meningococcal vaccine
- •Prior history of any invasive meningococcal disease
结局指标
主要结局
Local and systemic reactions through 14 days post-injection; Vaccinations at 0,1,6 months
时间窗: Vaccinations at 0,1,6 months
次要结局
未报告次要终点
研究者
研究点 (1)
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