A Randomized, Multi-center, Controlled Clinical Trial for Evaluating the Immunogenicity and Safety of Sequential Immunization Schedules of Sabin IPV and bOPV
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 604
- 试验地点
- 1
- 主要终点
- Seroconversion rates at both baseline and 30 days after the 3rd vaccination
研究概览
简要总结
The purpose of this study is to evaluate the immunogenicity and safety of sequential immunization schedules of Sabin IPV and bOPV.
详细描述
A phase 4 clinical trial is designed to evaluate the safety and immunogenicity of different sequential immunization schedules of Sabin IPV and bOPV. To be specific, the subjects were divided into 3 groups.
Group 1 received Sabin-IPV+bOPV+bOPV respectively at the age of 2,3,4 months old.
Group 2 received Sabin-IPV+Sabin-IPV+bOPV respectively at the age of 2,3,4 months old.
Group 3 received Sabin-IPV+Sabin-IPV+Sabin-IPV respectively at the age of 2,3,4 months old.
Blood samples were collected before vaccination and 30 days after the third dose. Neutralization antibody against type I, Type II and Type III poliomyelitis virus were detected to evaluate the seroprotection rates and antibody geometric mean concentrations. The safety of the 3 immunization schedule groups were also monitored.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Days 至 89 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •subjects aged from 60 days to 89 days old at the date of recruitment;
- •with informed consent signed by parent(s) or guardians;
- •parent(s) or guardians are able to attend all planned clinical appointments and obey and follow all study instructions;
- •subjects did not receive any vaccination within 14 days;
- •axillary temperature ≤37.0℃
排除标准
- •allergic to any ingredient of vaccine or with allergy history to any vaccine;
- •acute febrile disease or infectious disease;
- •serious chronic diseases;
- •any other factor that makes the investigator determines the subject is unsuitable for this study;
研究组 & 干预措施
sIPV+bOPV+bOPV
202 subjects were vaccinated with 1 dose of Sabin-IPV and 2 doses of bOPV at their age of 2/3/4 months old, respectively
干预措施: Sabin-IPV+bOPV+bOPV (Biological)
sIPV+sIPV+bOPV
197 subjects were vaccinated with 2 doses of Sabin-IPV and 1 dose of bOPV at their age of 2/3/4 months old, respectively
干预措施: Sabin-IPV+Sabin-IPV+bOPV (Biological)
sIPV+sIPV+sIPV
205 subjects were vaccinated with 3 doses of Sabin-IPV at their age of 2/3/4 months old, respectively
干预措施: Sabin-IPV+Sabin-IPV+Sabin-IPV (Biological)
结局指标
主要结局
Seroconversion rates at both baseline and 30 days after the 3rd vaccination
时间窗: 4 months
Determine the seroconversion rates of poliovirus (types I,II,III）at both baseline and 30 days after the 3rd vaccination
次要结局
- Neutralizing antibody titers at both baseline and 30 days after the 3rd vaccination(4 months)