A Study to Evaluate the Persistence of Antibody Seven Years After a Booster Dose of Either a Glycoconjugate or a Polysaccharide Vaccine Against Serogroup C Neisseria Meningitidis Given to Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Percentage of participants with rSBA titre ≥1:8 (correlate of protection).
研究概览
简要总结
The main purpose of this study is to evaluate the duration of immunity after a booster dose of a MenC-CRM vaccine given to adolescents between 13 and 15 years of age. Does seroprotection persist beyond teenage years and into the early twenties? This is the age group which is most likely to carry the organism and to transmit it to other members of the population. If a booster dose of MenC vaccine given to adolescents does produce protective levels of antibody which persist into early adulthood, this would strengthen the case for such a booster to be added to the UK routine immunisation schedule, to reduce the risk of a resurgence of the disease in the future.
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
- 20 Years 至 23 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants who completed clinical study M14P2E1
- •Participant who are willing to participate and who would be expected to comply with the requirements of the protocol
- •Participants who have given informed consent for participation in the study
排除标准
- •History of invasive meningococcal C disease (or any case of invasive meningococcal disease where the serotype was unknown)
- •Confirmed or suspected immunosuppressive or immunodeficient conditions, including human immunodeficiency virus (HIV) infection
- •Severe blood clotting disorders
结局指标
主要结局
Percentage of participants with rSBA titre ≥1:8 (correlate of protection).
时间窗: 4 months
次要结局
- Geometric mean titre (GMT) rSBA.(4 months)