The Phase Ⅲ Clinical Trial Protocol for the Inactivated Poliomyelitis Vaccine Made From Sabin Strains
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,200
- 试验地点
- 2
- 主要终点
- The study on immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains on Healthy infants
研究概览
简要总结
Based on pre-clinical trial and phase 1 and phase 2 clinical data and principle of GCP, the objective of phase Ⅲ clinical trial is to evaluate safety and immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains(Sabin IPV).
详细描述
The Sabin IPV was manufactured with poliovirus type 1, 2, 3 Sabin strains and Vero cells by microcarrier culture in 550 liter bioreactors. The virus suspension was harvested, ultra-concentrated, purified and inactivated with formalin. The D Ag contents of Sabin IPV were type 1 30DU, type 2 32DU, type 3 45DU /0.5ml/per dose.
Inactivated Poliomyelitis Vaccine (Salk strains) was manufactured by Sanofi Pasteur D Ag contents /0.5ml/per dose were type 1 40DU, type 2 8DU, type 3 32DU.
This is a randomized, blind phase 3 clinical trial. Total 1200 infants (ages 60 days to 90 days) were selected, randomized to two groups (Sabin IPV and Salk IPV, each group n=600), infants in each group will be vaccinated with three doses of either Sabin IPV or Salk IPV respectively, one month apart.
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 90 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females, age from 60 days to 90 days;
- •Adults, parent(s) or guardians are able to understand and sign informed consent for participation;
- •Participants or guardians are able to attend all planned clinical appointment and obey and follow all study instructions;
- •Infants no vaccinated with poliovaccine or other preventive biologicals in recent 7 days;
- •Axillary temperature ≤37℃.
排除标准
- •Have medical record of participants or their family on allergy, convulsion, falling sickness, encephalopathy and psychopathy;
- •Low platelet or bleeding disorder do not allow vaccination into the muscle;
- •Have damaged or lower immunological function;
- •Received blood, plasma or immunoglobulin treatment since birth;
- •Have inborn abnormality, develop obstacles or clinical diagnostic serious chronic ( Down Syndrome, diabetes, sickle cell anemia or neural Guillain-Barre Syndrome );
- •Have or be doubtful of following diseases: respiratory system diseases, acute infection or active chronic, cardiovascular diseases, liver and kidney diseases, skin diseases, HIV.
- •Exclusion Criteria for doses 2 and 3
- •Have serious anaphylaxis or high fever, convulsion during first dose;
- •Have any circus of Exclusion Criteria after Eligible for study;
- •Have serious adverse event which related to previous vaccination; Withdrawal and Discontinuance Criteria;
- •Received necessary or interference study drugs such as: immune-inhibition or immune-stimulating agents;
- •Vaccinated with any other vaccine（except DTP）;
- •Stop observation determined by investigator owing to occurring serious adverse event.
结局指标
主要结局
The study on immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains on Healthy infants
时间窗: fours year
Parallel study on comparison of sera protection rates (Neutralization antibody titer ≥1:8) of Sabin IPV and Salk IPV after three doses of vaccination.
次要结局
- Mucosal Immunity - Comparison of intestinal excretion of polioviruses following one dose of tOPV after three doses of IPV(30-60 days after third dose immunization)
- The study on efficacy of Inactivated Poliomyelitis Vaccine made from Sabin Strains on Healthy infants(One year)