NCT00297817已完成2 期
A Phase 2, Single-Blind, Controlled, Randomized Study of the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine ± OMV When Administered at an 0-2-6-Month Schedule in Healthy Adolescents 11-18 Years of Age
Novartis Vaccines8 个研究点 分布在 1 个国家目标入组 203 人开始时间: 2006年2月最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 203
- 试验地点
- 8
- 主要终点
- Safety, tolerability and immunogenicity as measured by serum bactericidal activity of the two vaccines in healthy adolescents
研究概览
简要总结
The purpose of this study is to evaluate the safety and immunogenicity of two serogroup B meningococcal vaccines in comparison to placebo administered to healthy adolescents ages 11 to 18 years.
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
- Single (Participant)
入排标准
- 年龄范围
- 11 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Adolescents between and including 11-18 years of age, who provide written informed consent.
排除标准
- •Previous or suspected disease caused by N. meningitidis; or previous immunization with a serogroup B meningococcal vaccine; Any acute, chronic or progressive disease.
结局指标
主要结局
Safety, tolerability and immunogenicity as measured by serum bactericidal activity of the two vaccines in healthy adolescents
时间窗: 1 month after completion of immunization schedule
次要结局
- Safety, tolerability and immunogenicity as measured by serum bactericidal activity of the two vaccines in healthy adolescents(6 months after completion of immunization schedule)
研究者
研究点 (8)
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