Phase 2/3 Clinical Trial to Assess the Safety and Immunogenicity of Live Attenuated Poliomyelitis Vaccine (Human Diploid Cell)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- Comparison of virogene VP1 genovariation between vaccinal I-III Sabin strains and poliovirus separated from faeces of study objects after vaccinated
研究概览
简要总结
The purpose of this Phase 2/3 trial is to assess the safety and immunogenicity of Live attenuated Poliomyelitis vaccine (human diploid cell)
详细描述
Live attenuated Poliomyelitis vaccine (human diploid cell) is used for poliovirus prevention in children above 2 years old , Which was developed by Institute of Medical Biology , Chinese Academy of Medical Sciences , based on the other two products : Poliomyelitis Vaccine in Dragee Candy (Monkey Kidney Cell), Live ; and Poliomyelitis（Live）Vaccine (Monkey Kidney Cell),Oral . After its safety been proved in phase 1 clinical trail evaluation , the phase 2/3 trail was started in Guangxi Province, China during 2011-2012. The purpose of this trial is to assess the safety and immunogenicity in healthy children of 2,3 and 4 months old .
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 2 Months 至 4 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Only subjects fulfilling all of the following criteria will be eligible for the study:
- •People aged from 2 months to 4 months old.
- •The subjects or subjects' guardians are able to understand and sign the informed consent
- •The subjects or subjects' guardians allow to comply with the requirements of the protocol
- •Subjects with temperature <=37.0°C on axillary setting
- •The subjects have signed informed consent already
排除标准
- •The subjects have never been vaccinated with any Poliomyelitis Vaccine.
结局指标
主要结局
Comparison of virogene VP1 genovariation between vaccinal I-III Sabin strains and poliovirus separated from faeces of study objects after vaccinated
时间窗: up to 90 days
20 children aged 4 years old and 20 infants aged 2 months were vaccinated with 3 dose of Live attenuated Poliomyelitis vaccine (human diploid cell). Their faeces on day 0,7,30,60 and 90 were collected and incubated in L20B and RD cells for 2 generations, in order to separate and amplify poliovirus I-III Sabin strains in faeces of study objects . Extract total viral RNA from the culture supernatants and detect virogene VP1 through RT-PCR and sequencing ,in order to test the genovariation of vaccinal I-III Sabin strains in faeces after vaccinated .
次要结局
- Change of seroconversion from baseline to 3 months(up to 3 months)
- The frequency of all the adverse events in vaccine group and placebo group(up to 30 days)