Evaluation of the Antibody Persistence in African Participants Beyond Five Years After Immunization With MenFiveTM (NmCV-5), a Pentavalent Meningococcal ACYWX Conjugate Vaccine
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 450
- 试验地点
- 2
- 主要终点
- Geometric mean titers (GMTs) measured by rSBA against serogroups A, C, Y, W and X
研究概览
简要总结
This study will measure immune persistence of the NmCV-5 more than 5 years after a single dose vaccination in participants 2-29 years of age in Mali and The Gambia.
详细描述
This non-interventional long-term follow-up study will involve one telephonic contact in all 1800 former participants from study ACYWX-03 followed by one visit beyond five years after vaccination in a subset of 450 participants. This subset will be randomly selected to participate in a follow-on immune persistence evaluation. To document the duration of the immune response and any requirement of booster dose in the target population, this study is intended to explore antibody persistence.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 7 Years 至 36 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed consent and assent (if applicable)
排除标准
- •Current or previous, confirmed disease caused by Neisseria meningitidis at any given time since meningococcal vaccination
- •Any condition or criteria that in the opinion of the investigator might compromise the well-being of the participant or the compliance with study procedures or interfere with the outcome of the study
研究组 & 干预措施
NmCV-5
MenACWY-D
结局指标
主要结局
Geometric mean titers (GMTs) measured by rSBA against serogroups A, C, Y, W and X
时间窗: five-six years after vaccination.
次要结局
- Percentage of participants with rSBA titers ≥ 8(five-six years after vaccination.)
- Percentage of participants with rSBA titers ≥ 128(five-six years after vaccination)