NCT00700635已完成2 期
Exploratory Evaluation of a Two-dose Schedule Versus a One-dose Schedule of Menactra® (Meningococcal [Groups A, C, Y and W 135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) in Children in the US
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 333
- 试验地点
- 15
- 主要终点
- Percentage of Participants With Meningococcal Antibody Titers ≥ 8 After Each Vaccination
研究概览
简要总结
To explore the potential benefit of the administration of Menactra vaccine as a two-dose regimen to children.
Primary Objective:
To assess, by age group, the immune response to Menactra vaccine after each vaccine injection.
详细描述
This is an open-label trial designed to explore the immune response to a two-dose schedule of Menactra vaccine compared with a standard one-dose schedule in children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Percentage of Participants With Meningococcal Antibody Titers ≥ 8 After Each Vaccination
时间窗: 30 days post-vaccination
Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by serum bactericidal assay using human complement (SBA-HC)
次要结局
- Geometric Mean Titers (GMTs) of Meningococcal Antibodies After Each Menactra® Vaccination.(30 days post-vaccination)
- Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination(7 days post-vaccination 2)
- Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination(7 days post-vaccination 1)
- Percentage of Participants With Meningococcal Antibody Titers at ≥ 4 After Each Vaccination(30 days post-vaccination)
研究者
研究点 (15)
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