NCT03561181已完成1 期
A Single-center, Open, Phase I Clinical Trial to Evaluate Safety of S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine in Healthy Volunteers Aged Above 3 Months
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Occurrence of adverse events during a 30 day follow-up period after each vaccination
研究概览
简要总结
The purpose of this study is to evaluate safety of S.flexneriza-S.sonnei Bivalent Conjugate Vaccine in healthy volunteers aged above 3 Months.
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
- 3 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •3 months old and above healthy people.
- •Subject or legal representative who consent and has signed written informed consent.
- •Subject and parent/guardian who is able to comply with all study procedures.
- •Subject who did't receive blood products within 30 days ,immune with any live vaccine within 14 days and inactivated vaccine within 7 days before vaccination.
- •Axillary temperature ≤37.0 ℃.
排除标准
- •Febrile illness (temperature ≥ 38°C) in the 3 days.
- •Subject who are allergic to tetanus toxoid.
- •Allergic history after vaccination.
- •Immunodeficiency diseases patients who administered with immunosuppressive agents.
- •In pregnancy or lactation or pregnant women.
- •Subject who are suffering from serious chronic diseases, infectious diseases, active infection, cardiovascular disease,liver or kidney disease.
- •Subject who have symptoms such as diarrhea, abdominal pain, and pus and bloody stools in the past 3 days.
- •History of allergy，eclampsia, epilepsy,brain trauma,encephalopathy and mental disease or family disease.
- •Subject who diagnosis of thrombocytopenia or other history of coagulopathy may cause intramuscular contraindication.
- •Children with abnormal labor（pregnancy week<37w,>42w）,birth weight (<2500g,>4000g), asphyxia rescue history,congenital malformations or developmental disorders(Only applicable to 3-5 months old group)
- •Blood routine, blood chemistry and urinalysis laboratory collection abnormalities and the severity of grade 2 and above before immunization.
- •Subject who plan to participate in or is in any other drug clinical trial.
- •Any condition that, in the judgment of investigator, may affect trial assessment.
研究组 & 干预措施
High dose Group
Experimental
Received Vaccine: S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine,10μg/dose
干预措施: S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine (Biological)
low dose Group
Experimental
Received Vaccine: S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine,5μg/dose
干预措施: S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine (Biological)
结局指标
主要结局
Occurrence of adverse events during a 30 day follow-up period after each vaccination
时间窗: 30 day after each vaccination
次要结局
未报告次要终点
研究者
研究点 (1)
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