NCT04133584已完成4 期
Multiple Centers, Randomized, and Control Trail on the Immunogenicity and Safety of the Simultaneously Vaccination of Inactivated Enterovirus 71 Vaccine (EV71) and Seasonal Influenza Vaccine(SIV)
Zhejiang Provincial Center for Disease Control and Prevention1 个研究点 分布在 1 个国家目标入组 1,134 人开始时间: 2019年9月16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
- 1,134
- 试验地点
- 1
- 主要终点
- immunogenicity evaluation
研究概览
简要总结
The purpose of this study is to evaluate the Immunogenicity and safety of the simultaneously vaccination of Inactivated Enterovirus 71 Vaccine (EV71) and seasonal influenza vaccine(SIV)
详细描述
Main subjects:
The seroconversion rate for each antigen when EV71 is administrated with SIV
Secondary subjects:
The positive rate of antibody for each antigen when EV71 is administrated with SIV The safety for each antigen when EV71 is administrated with SIV
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
- 6 Months 至 11 Months（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 ≥ 6 month to <12 months.
- •Participant without preventive inoculation of Enterovirus 71 Vaccine ,seasonal influenza vaccine vaccine and previous history of Enterovirus.
- •Subject and parent/guardian able to attend all scheduled visits and comply with all trial procedures.
- •Body temperature ≤ 37.0#.
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
immunogenicity evaluation
时间窗: change from baseline antibody concentration at 28 days after the last dose
The positive rate of antibody
次要结局
- safety evaluation: The occurrence of adverse events(up to 30 days after every injection)
研究者
研究点 (1)
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