NCT03147560已完成4 期
Immunogenicity and Safety Evaluation of Different Sequential Immunization Strategies by Sabin IPV and bOPV in Chinese Infants
Zhejiang Provincial Center for Disease Control and Prevention2 个研究点 分布在 1 个国家目标入组 528 人开始时间: 2017年5月2日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 528
- 试验地点
- 2
- 主要终点
- seroconversion rate
研究概览
简要总结
The purpose of this study is to evaluate the immunogenicity and safety of different sequential immunization strategies by Sabin IPV and bOPV in Chinese 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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Days 至 75 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parent/legal acceptable representative is willing and able to understand the protocol requirements and provide informed consent.
- •Participant is aged ≥ 60 days to ≤ 75 days.
- •Participant without preventive inoculation of polio vaccine and previous history of Polio.
- •Subject and parent/guardian able to attend all scheduled visits and comply with all trial procedures.
- •Body temperature ≤ 37.5℃.
排除标准
- •Known allergy to any constituent of the vaccine.
- •Known acute illness, severe chronic disease, acute exacerbation of chronic disease and fever.
- •Known or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth.
- •Reported the history of allergies, convulsions, epilepsy, mental illness and brain disease and clear serious systemic reaction.
- •Known bleeding disorder.
- •Receipt of the whole blood, blood plasma or immunoglobulin before the trial vaccination.
- •Reported the history of acute illness had need systemic antibiotics or antiviral treatment of infections in the 7 days preceding the trial vaccination.
- •An acute illness with or without fever (temperature ≥ 38.0℃) in the 3 days preceding enrollment in the trial.
- •Participation in any other intervention clinical trial.
- •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
seroconversion rate
时间窗: seroconversion rate was evaluated 4-5 weeks after the third dose of polio vaccine.
any positive antibody response in infants who were seronegative prior to their first dose, or at least a fourfold increase in type-specific antibody levels for infants who had pre-existing antibodies.
次要结局
- neutralizing antibody titer(Blood samples were obtained prior to the first dose and 4-5 weeks after the third dose of polio vaccine.)
- safety: rate of adverse events(At least 2 active surveillance visits (3 days and 30 days) were required after each vaccination to collect adverse reaction data.)
研究者
研究点 (2)
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