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临床试验/NCT02901990
NCT02901990已完成不适用

Observational Cohort Study to Evaluate Immunogenicity, Protection, and Persistence of Antibody to Mumps in 3-7 Years' Children Received One-dose Mumps-containing Vaccine

Jiangsu Province Centers for Disease Control and Prevention6 个研究点 分布在 1 个国家目标入组 7,901 人开始时间: 2015年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
7,901
试验地点
6
主要终点
to describe the sero-prevalence in specific age groups following an active surveillance of vaccinated subjects in each year

研究概览

简要总结

This study was aimed to conduct a 3-year perspective study to observe the immunological effect of one-dose mumps-containing vaccine, monitor the incidence of mumps in vaccinated population aged 3-7 years,and provide basis for adjusting MMR immunization strategy in Jiangsu province, China.

详细描述

in 3-7 years old children with high risk of mumps, epidemiological investigation of the serum IgG antibody level were conducted, and then a prospective observational cohort was established in the population with a history of mumps vaccination, and the incidence of mumps in each antibody level group will be observed, the relationship between different antibody levels and the incidence after mumps vaccinated were analyzed, to explore attenuation of mumps IgG antibody levels in the body,S79 vaccine strain against F genotype mumps' antigenic cross-reactivity and the protective effect of antibodies.

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
3 Years 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged 3-7 years old;
  • local resident children living at least 3 months;
  • physical health, has been vaccinated at least once a dose of MuV

排除标准

  • did not administer MuV;
  • refused to collect venous blood;
  • have been infected with mumps;
  • have serious illness or other reasons should not participate in the study after clinical evaluation

结局指标

主要结局

to describe the sero-prevalence in specific age groups following an active surveillance of vaccinated subjects in each year

时间窗: 3 years

次要结局

  • to describe wane immunity of IgG antibody to mumps virus in specific age groups following an active surveillance of vaccinated subjects in each year(3 years)
  • To characterize the incidence of mumps in specific age groups following an active surveillance of vaccinated subjects in each year(3 years)

研究者

申办方类型
Network
责任方
Sponsor

研究点 (6)

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