A Randomized, Blinded, Parallel Positive-controlled Clinical Trial of Sequential Vaccination of Sabin Inactivated Poliomyelitis Vaccine (Vero Cell) and Live Attenuated Poliomyelitis Vaccine in Healthy 2-month-old Infants
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- The positive seroconversion rates of poliovirus type I, type II and type III neutralizing antibody
研究概览
简要总结
The goal of this clinical trial is to evaluate the immunogenicity and safety of a Sabin Inactivated Poliomyelitis Vaccine (sIPV) and a commercially available Live Attenuated Poliomyelitis Vaccine (bOPV) according to the "2+1 sequential" immunization program (sIPV-sIPV-bOPV) in 2-month-old healthy infants.
详细描述
A total of approximately 300 infants 2 months of age (over 60 days old and less than 90 days old) will be enrolled and randomized in 1:1 ratio into the study group and control group, with 150 participants in each group.The study group will receive study sIPV developed by Biominhai and control group will receive wIPV developed by SANOFI PASTEUR S.A. The "2+1 sequential" procedure consists of 2 doses of inactivated vaccine (sIPV or wIPV) and 1 dose of bOPV, a total of 3 doses, with 1 month between each vaccination. This study has indicated that the sIPV is not inferior to the wIPV in terms of immunogenicity and safety according to the "2+1 sequential" immunization program in 2-month-old healthy infants.
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
- Double (Participant, Investigator)
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
- •Healthy permanent residents aged 2 months (over 60 days and less than 90 days);
- •Infant's legal guardians agree to sign the informed consent forms voluntarily;
- •Infant's legal guardians are able to comply with the requirements of the clinical trial protocol;
- •Armpit temperature ≤ 37.0 ℃
排除标准
- •Preterm birth (delivery before the 37th week of pregnancy).
- •Previous vaccination against polio.
- •Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
- •History of polio.
- •History or family history of convulsions, seizures, encephalopathy, and neurological disorder.
- •History of a serious reaction to any prior vaccination or known hypersensitivity to any component of the investigational vaccine.
- •Individuals with immunodeficiency or receiving immunosuppression therapy.
- •Disturbance of coagulation diagnosed by doctor (e.g., coagulation factors deficiency, coagulation disease, platelet abnormality) or obvious bruising or coagulation disorder.
- •Known or suspected concomitant diseases include: respiratory disease, acute infection or active chronic disease, cardiovascular disease, liver and kidney disease, skin disease, mother with HIV infection.
- •Administration of blood or blood-related products or immunoglobulins (hepatitis B immunoglobulins is acceptable).
- •History of administration of live attenuated vaccines within 14 days.
- •History of administration of subunit or inactivated vaccines within 7 days.
- •Individuals with any acute diseases within 7 days, receiving antibiotics or antiviral therapy.
- •Fever within 3 days (Armpit temperature ≥38.0 ℃).
- •Use of any investigational product recently, or have any conditions that the investigator believes may affect the evaluation of the trial.
研究组 & 干预措施
study group
study group: sIPV-sIPV-bOPV, a total of 3 doses, with 1 month between each vaccination; 150 participants
干预措施: sIPV+bOPV (Biological)
control group
control group: wIPV-wIPV-bOPV, a total of 3 doses, with 1 month between each vaccination; 150 participants
干预措施: wIPV+bOPV (Biological)
结局指标
主要结局
The positive seroconversion rates of poliovirus type I, type II and type III neutralizing antibody
时间窗: Day 30 post full vaccination
次要结局
- GMT of poliovirus type I, type II and type III neutralizing antibody(Day 30 post full vaccination)
- GMI of poliovirus type I, type II and type III neutralizing antibody(Day 30 post full vaccination)
- The seropositive rates of poliovirus type I, type II and type III neutralizing antibody(Day 30 post full vaccination)
- The ratio of poliovirus type I, type II and type III neutralizing antibody titer ≥1:64(Day 30 post full vaccination)
- Incidence of adverse reactions/events(30 days after each dose of vaccination)
- Incidence of serious adverse events (SAE)(From the first immunization to 6 months after the last immunization)