A Prospective, Multi-national, Multi-center, Double-blind, Randomized, Active Controlled, Parallel-group, Seamless Phase II/III Clinical Study to Evaluate the Safety and Immunogenicity of 'LBVC (Sabin Poliomyelitis Vaccine (Inactivated))' Compared With 'Imovax® Polio (Poliomyelitis Vaccine (Inactivated))' in Healthy Infants
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,417
- 试验地点
- 3
- 主要终点
- Stage1: Seroconversion rate(%)
研究概览
简要总结
The purpose of the study is to evaluate safety and immunogenicity of inactivated poliomyelitis vaccine based on Sabin strain (LBVC) in healthy infants to select optimal dose of LBVC as well as to demonstrate the lot-to-lot consistency and non-inferiority of LBVC.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Weeks 至 8 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy infants of either sex who have reached at least 42 days (6 weeks) of age and not more than 56 days (8 weeks) of age at the time of enrollment
- •Born at full term of pregnancy (Gestational age ≥37 weeks)
- •Body weight ≥ 3.2 kg at the time of screening
- •Born to HIV negative mother
- •The parents or Legally Acceptable Representative (LAR) able to understand and comply with planned study procedures
- •Signed informed consent by subject's parents or Legally Acceptable Representative (LAR)
排除标准
- •Previously received any polio vaccines (OPV or IPV)
- •History of previous or concurrent vaccinations other than HepB, BCG, DTP, Hib, Rotavirus vaccine and PCV
- •History of bleeding disorder contraindicating intramuscular injection.
- •Experienced fever ≥ 38 °C/ 100.4 °F within the past 3 days prior to the screening
- •Receipt of immunoglobulin or blood-derived product since birth
- •History of allergic reactions to any vaccine components, including excipients and preservatives (neomycin, streptomycin and polymyxin B, etc.)
- •Known or suspected immune disorder, or received immunosuppressive therapy
- •History of poliomyelitis
- •History of any neurological disorders or seizures
- •Known or suspected febrile, acute or progressive illness
- •Household contact and/or intimate exposure in the previous 30 days to an individual with poliomyelitis
- •Participation in another interventional trial within 30 days before to the enrollment or simultaneous participation in another clinical study
- •Infants whose families are planning to leave the area of the study site before the end of the study period
- •Infants who is considered unsuitable for the clinical study by the investigator
研究组 & 干预措施
Test group 1
Low dose (Stage2: Lot A) of investigational inactivated poliomyelitis vaccine based on Sabin strains (LBVC)
干预措施: Inactivated Poliomyelitis Vaccine (Sabin strain) (Biological)
Test group 2
Middle dose (Stage2: Lot B) of investigational inactivated poliomyelitis vaccine based on Sabin strains (LBVC)
干预措施: Inactivated Poliomyelitis Vaccine (Sabin strain) (Biological)
Test group 3
High dose (Stage2: Lot C) of investigational inactivated poliomyelitis vaccine based on Sabin strains (LBVC)
干预措施: Inactivated Poliomyelitis Vaccine (Sabin strain) (Biological)
Comparator
Cormmercialized inactivated poliomyelitis vaccine based on Sabin strains (Imovax Polio)
干预措施: Inactivated Poliomyelitis Vaccine (Salk strain) (Biological)
结局指标
主要结局
Stage1: Seroconversion rate(%)
时间窗: 4 weeks after 3rd vaccination
Proportion of subjects achieving seroconversion of each poliovirus serotype using microneutralization assay
Stage2: Seroconversion rate(%)
时间窗: 4 weeks after 3rd vaccination
Proportion of subjects achieving seroconversion of each poliovirus serotype using microneutralization assay
次要结局
- Stage1: GMTs (Geometric Mean Titers)(4 weeks after 2nd and 3rd vaccination)
- Stage1: Seroconversion rate (%)(4 weeks after 2nd vaccination)
- Stage2: Seroprotection rate (%)(4 weeks after 3rd vaccination)
- Stage2: GMTs (Geometric Mean Titers)(4 weeks after 3rd vaccination)