Immunogenicity and Safety of the Booster Dose of Polio Vaccine Immunization Using Sabin IPV or bOPV at Children Aged 4 Years With Different Three Sequential Schedules History by Sabin IPV or bOPV in China
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 387
- 试验地点
- 2
- 主要终点
- Persistence (tite rates) of antibodies against poliovirus 3 years after the primary 3 dose polio vaccine immunization
研究概览
简要总结
This study is to evaluate the immunogenicity and safety of Sabin IPV or bOPV, given as a booster vaccination in children aged 4 years who were previously immunised with different sequential immunization history by Sabin IPV and bOPV, and to observe the antibody persistence three years after different primary sequential immunization with Sabin IPV or bOPV at age 2, 3 and 4 months.
详细描述
This is a continuous study of preliminary trial (Immunogenicity of three sequential schedules with Sabin inactivated poliovirus vaccine and bivalent oral poliovirus vaccine in Zhejiang, China: NCT03147560) . The investigators will follow up previous participants at age 4 years old with different primary sequential immunization schedules at age 2, 3 and 4 months: sIPV-bOPV-bOPV , sIPV-sIPV-bOPV , or sIPV-sIPV-sIPV, and give the 4th doses of polio vaccine with Sabin IPV or bOPV. A pre-vaccination blood sample is taken for polio antibody determinations. Sabin IPV will be administrated for participants in the previous Group 1 (sIPV-bOPV-bOPV), and Sabin IPV or bOPV will be given for participants in the previous Group 2 (sIPV-sIPV-bOPV) and Group 3 (sIPV-sIPV-sIPV) after they were randomly divided into two subgroups. At least two active surveillance visits, during which staff visited the participants s at home (on days 3 and 30) will required after vaccination to collect adverse reaction data. Parents or legal guardians were instructed to contact investigators if they observed any possible vaccine-related adverse events or important medical events (such as serious illness, physical disability, or death). The second blood sample will be collected 28-60 days after the booster vaccination. The investigators will asess the immunogenicity by seroconversion rate and seropositivity after the booster vaccination, and evaluate the antibody persistence using seropositive rate and GMT in participants before the booster vaccination. Safety will assessed with the occurrence of adverse events reported across the study groups.
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
- None
入排标准
- 年龄范围
- 48 Months 至 51 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants aged ≥48 months to ≤ 51 months from preliminary study (NCT03147560) with sequential immunization history by Sabin IPV and bOPV.
- •Parent/legal acceptable representative is willing and able to understand the protocol requirements and provide informed consent.
- •≥ 14 days interval between the last vaccination.
- •Body temperature ≤ 37.2℃.
排除标准
- •Known acute illness, severe chronic disease, acute exacerbation of chronic disease and fever.
- •Known allergy to any constituent of the vaccine.
- •Had 4 doses vaccination record of polio vaccine.
- •Known impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin .
- •Received non-specific immunoglobulin within 1 month.
- •An acute illness with fever (temperature ≥ 37.3℃) or any infectious diseases.
- •Patients with a well-diagnosed history of thrombocytopenia or other coagulation disorders that may cause contraindications for injection.
- •Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the vaccine.
结局指标
主要结局
Persistence (tite rates) of antibodies against poliovirus 3 years after the primary 3 dose polio vaccine immunization
时间窗: 3 years after the primary three doses of polio immunization(before the booster vaccination )
The percentage of participants with positive antibody(titre ≥ 8) against all three serotypes of poliovirus 3 years after the primary immunization with different sequential immunization schedules using sIPV or bOPV
Seroconversion rates of the booster vaccination
时间窗: before and 28-60 days after the booster dose (4 years old) of polio vaccine
Defined as any positive antibody (titre ≥ 8) response in children who were seronegative prior to the vaccination, or at least a fourfold increase in type-specific antibody levels for children who had pre-existing positive antibodies
Seroprotection rates after the booster vaccination
时间窗: 28-60 days after the booster dose (4 years old) of polio vaccine
The percentage of participants with positive antibody(titre ≥ 8) against all three serotypes of poliovirus
次要结局
- Antibody titers pesistence against poliovirus(3 years after the primary three doses of polio immunization(before the booster vaccination ))
- Safety of the booster dose of polio vaccine immunization(30 days after the booster vaccination)
- Antibody titers against poliovirus after the booster immunization(28-60 days after the booster dose of polio vaccine given)