Antibody Responses to a Booster Dose of an Experimental Tetravalent (A, C, Y, and W-135) Meningococcal Diphtheria Toxoid Conjugate Vaccine, Menactra® in Adolescents Who Previously Received Menomune® or Menactra®
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 241
- 试验地点
- 9
- 主要终点
- Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups.
研究概览
简要总结
This study was designed to evaluate the antibody response to a Menactra® booster dose in participants who previously received one dose of Menactra® or Menomune® as adolescents 3 years earlier in Study MTA02.
Primary Objective:
To evaluate the antibody responses to a booster dose of a tetravalent meningococcal diphtheria toxoid conjugate vaccine (Menactra®) in participants who had previously received Menactra® or Menomune® as adolescents in the MTA02 Study and antibody responses to a dose of Menactra® in naive adolescents.
详细描述
All subjects were given a single boosting dose of Menactra® to evaluate the kinetics of the response, the magnitude and the avidity of the antibody produced.
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
- 13 Years 至 21 Years（Child, Adult）
- 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
Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups.
时间窗: Day 0 and 8 and 28 days post-vaccination
Geometric mean titers and their 95% confidence interval of serum bactericidal activity for the 4 vaccine serogroups before vaccination, at 8 days post- and 28 days post-booster dose of Menactra vaccine or a primary dose of Menactra vaccine in the meningococcal vaccine-naïve Control group.
次要结局
未报告次要终点