Immunogenicity After Primary Immunization and Booster Immunization of Sabin Strain Inactivated Polio Vaccine (Vero Cells) in Infants and Young Children and Enterovirus Serological Monitoring Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 233
- 试验地点
- 1
- 主要终点
- seropositive rate of antibodies against different enteroviruses (EV71/CA16/CA6/CA10) in infants and young children
研究概览
简要总结
This study was conducted on the basis of "Safety Observation of Sabin Strain Inactivated Polio Vaccine (Vero Cell) on primary Immunization, Booster Immunization and Simultaneous Vaccination with Other Vaccines in Infants and Young Children(ID: PRO-sIPV-MA4001-JX). Blood samples were collected in about 200 qualified subjects 1-9 months after their last vaccination of sIPV. And immunogenicity of sIPV and other vaccines simultaneously administrated will be tested, the antibodies against enterovirus (including EV71、CA16、CA6 and CA10) will also be tested.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Months 至 27 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participated in the previous study (ID: PRO-sIPV-MA4001-JX)
- •Subjects in the Primay immunization group(aged 2-3 months) need to complete 3 doses of sIPV vaccination, and the simultaneous vaccination group DTaP needs to complete 3 doses of vaccination; the booster immunity group(aged more than 18 months) needs to complete sIPV vaccination, and the simultaneous vaccination group needs to complete the corresponding vaccination;
- •There should be an interval of 1-9 months between the last dose of vaccination and the date of blood sample collection;
- •The guardian of subjects need to agree to sign the informed consent form.
排除标准
- •The interval between vaccination and blood collection is less than 1 month, or more than 9 months;
- •Subjects were participating in other clinical studies of vaccines or drugs;
- •Other conditions that make subjects unsuitable for participating in this study judged by investigator's
结局指标
主要结局
seropositive rate of antibodies against different enteroviruses (EV71/CA16/CA6/CA10) in infants and young children
时间窗: 1 month
Antibody positivity rate of sIPV vaccine after primary immunization in infants
时间窗: 1 month
Antibody positivity rate of sIPV after booster immunization with sIPV vaccine in young children
时间窗: 1 month
次要结局
- GMT of sIPV after booster immunization with sIPV vaccine in young children(1 month)
- GMT of antibodies against different enteroviruses(1 month)
- GMT of sIPV vaccine after primary immunization in infants(1 month)