NCT00387725已完成2 期
A Randomized, Observer-blinded, Parallel-group, Active-control, Phase ½ Trial Of The Safety, Immunogenicity, And Tolerability Of 20 Mg, 60 Mg, And 200 Mg Of Meningococcal Group B Rlp2086 Vaccine In Healthy Children And Adolescents Aged 8 To 14 Years
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 127
- 试验地点
- 9
- 主要终点
- Percentage of Participants With Seroconversion in rLP2086 Specific SBA Titer 1 Month After Dose 3
研究概览
简要总结
Study to evaluate the safety of an investigational meningitis vaccine and the immune response to it in adolescents
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria
- •Aged 8 to 14 years at the time of enrollment.
- •Healthy male or female subjects
- •Negative urine pregnancy test for female subjects
排除标准
- •Exclusion Criteria
- •Prior vaccination with a meningococcal B vaccine
- •Prior meningococcal disease
研究组 & 干预措施
Group A
Experimental
20ug Experimental
干预措施: rLP2086 (Biological)
Group 4
Active Comparator
Active comparator
干预措施: rLP2086 (Biological)
Group 3
Experimental
200ug Experimental
干预措施: rLP2086 (Biological)
Group 2
Experimental
60ug Experimental
干预措施: rLP2086 (Biological)
结局指标
主要结局
Percentage of Participants With Seroconversion in rLP2086 Specific SBA Titer 1 Month After Dose 3
时间窗: 1 month after Dose 3
Percentage of Participants With at Least One Adverse Event (AE)
时间窗: Dose 1 up to 1 month after Dose 3
Percentage of Participants With Seroconversion in rLP2086 Specific Serum Bactericidal Assay (SBA) Titer 1 Month After Dose 2
时间窗: 1 month after Dose 2
次要结局
未报告次要终点
研究者
研究点 (9)
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