A Randomized, Controlled Trial to Compare Protection in Adolescents Between Different Meningococcal Immunization Schedules Used in Canada; a Canadian Immunization Research Network (CIRN) Study.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 244
- 试验地点
- 3
- 主要终点
- Confirm non-inferiority of MenC protection at 1-year post-MenACWY booster between groups with differing priming schedules
研究概览
简要总结
This study is to confirm non-inferiority of the three MenACWY vaccines (Menveo, Menactra or Nimenrix) in adolescents, and to identify whether the number of previous doses of MenC influences the response to the MenACWY vaccine.
详细描述
Participants will be randomized to receive one of the three doses of licensed MenACWY as a booster dose in adolescents. Serology will be collect at 3 time points; prior to the booster dose and 1 month and 1 year post-vaccination to measure antibody levels. The participants are healthy students in grades 7-9 who have not received their MenACWY vaccine yet and received their routine infant MenC vaccines per previous Canadian schedules.
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
- 11 Years 至 15 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
Confirm non-inferiority of MenC protection at 1-year post-MenACWY booster between groups with differing priming schedules
时间窗: 1 year following MenACWY adolescent booster
N. meningitidis capsular group C serum bactericidal antibody titer
Confirm non-inferiority of MenC protection at 1-year post-MenACWY booster between differing vaccines
时间窗: 1 year following MenACWY adolescent booster
N. meningitidis capsular group C serum bactericidal antibody titer
次要结局
- Confirm safety of MenACWY conjugate vaccines(Up to 1 month post-vaccine)
- Confirm non-inferiority of MenC protection at 1 month post-MenACWY booster between groups with differing MenC priming schedules.(1 month following MenACWY booster)
- Confirm non-inferiority of MenC protection at 1 month post-MenACWY booster between groups with different MenACWY vaccines(1 month following MenACWY booster)
- Subgroup analysis to determine effects of different MenC priming schedules in subjects receiving different MenACWY booster immunizations at 1 month and 1 year post-MenACWY booster(1 month and 1 year following MenACWY booster)
- Subgroup analysis to determine effects of different MenACWY vaccines in subjects primed with different MenC schedules at 1 month and 1 year post-MenACWY booster(1 month and 1 year following MenACWY booster)