A Study on Immunity Duration Against Polio Over 18 Months Infants After 2 or 3 Primary Doses Sabin Strain Inactivated Poliovirus Vaccine in China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 774
- 试验地点
- 1
- 主要终点
- Antibody persistence
研究概览
简要总结
In 2017, China CDC conducted a study titled "A Study of Immunogenicity and Seroconversion With Sabin IPV Schedules in China". At present, all the infants in the monitoring cohort were over 18 months old and at least one year had elapsed since the last dose of sIPV inoculation.Since there is no any data about the protection duration of two-dose Sabin IPV schedules, China CDC propose to follow up the study cohort to evaluate the proportion of seroprotection of antibody and measure neutralizing antibody titers against poliovirus at over 18 months of age infants after a 2-dose or a 3-dose primary schedule of Sabin IPV in Chinese children.
详细描述
In 2017, China CDC conducted a study titled "A Study of Immunogenicity and Seroconversion With Sabin IPV Schedules in China". This study offers evidence that two doses of sIPV administered at 4 and 8-11 months of age and three doses of sIPV administered at 2, 3, and 4 months of age both provide serological protection against poliomyelitis. At present, all the infants in the monitoring cohort were over 18 months old and at least one year had elapsed since the last dose of sIPV inoculation.
Since there is no any data about the protection duration of two-dose Sabin IPV schedules, China CDC propose to follow up the study cohort when all subjects are at least 18 months old to monitor persistence of antibody. So that, if the antibody levels are not high enough to protect children from the disease, remedial measures can be taken as soon as possible.So China CDC conduct this follow up study ,to
- Evaluate the proportion of seroprotection of antibody against poliovirus at over 18 months of age infants after a 2-dose or a 3-dose primary schedule of Sabin IPV in Chinese children.
- Measure neutralizing antibody titers against poliovirus type I, II and III at over 18 months of age infants after 2-dose Sabin IPV schedule, compared with 3-dose Sabin IPV schedule.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Months 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parent or legal guardian agree to participate in the follow study.
- •The subject was vaccinated either two doses or three doses Sabin IPV ,collected two blood samples and laboratory test results were available per protocol of pervious study
- •The subject is at least 18 months age.
排除标准
- •Parent or legal guardian does not agree to participate in the follow up study.
- •The subject has received any polio vaccine product beyond the protocol of previous study.
结局指标
主要结局
Antibody persistence
时间窗: 1 month
Evaluate the proportion of seroprotection of antibody against poliovirus at over 18 months of age infants after a 2-dose or a 3-dose primary schedule of Sabin IPV in Chinese children.
次要结局
- Neutralizing antibody titers(1 month)
研究者
AN Zhijie
Researcher of National Immunization Program
Centers for Disease Control and Prevention, China