A Randomized, Blinded, Single-center, Parallel Controlled , Phase Ⅱ Clinical Trial to Evaluate Immunogenicity and Safety of S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine in Healthy Volunteers Aged From 3 Months to 5 Years Old
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1,050
- 试验地点
- 1
- 主要终点
- incidence of adverse events during 30 days
研究概览
简要总结
The purpose of this study is to evaluate immunogenicity and safety of S.flexneriza-S.sonnei Bivalent Conjugate Vaccine in healthy volunteers aged from 3 months to 5 years old.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Health infants and children aged from 3 months to 5 years old.
- •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.
- •Subject who haven't immuned with diarrhea vaccination,3-11 months health infants who haven't immuned with Haemophilus b Conjugate vaccination,or had a history of Hib vaccination before the age of 1 but no history of vaccination after 1 year of age,and the interval between the day of the enrollment and the previous dose is more than one month.
- •Axillary temperature ≤37.0 ℃.
排除标准
- •Febrile illness (temperature ≥ 38°C) in the 3 days or in the acute phase of the disease / active period.
- •Subject who have symptoms such as diarrhea, abdominal pain, and pus and bloody stools in the past 3 days.
- •Subject who are allergic to tetanus toxoid.
- •Allergic history after vaccination.
- •Immunodeficiency diseases patients (such as perianal abscess suggests that there may be immunodeficiency in infants and young children) who administered with immunosuppressive agents (≥14 days).
- •Subject who are suffering from serious chronic diseases, cardiovascular disease,liver or kidney disease.
- •Subject with congenital malformations, drug allergies, convulsions, epilepsy, history of craniocerebral trauma, encephalopathy and psychosis, or family history.
- •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(Only applicable to 3-5 months old group).
- •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
S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine,10μg/dose
干预措施: S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine (Biological)
High dose Group
S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine,10μg/dose
干预措施: Haemophilus b Conjugate Vaccine (Biological)
Low dose Group
S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine,5μg/dose
干预措施: S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine (Biological)
Low dose Group
S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine,5μg/dose
干预措施: Haemophilus b Conjugate Vaccine (Biological)
Adjuvant-free Group
Adjuvant-free S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine,10μg/dose
干预措施: S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine (Biological)
Adjuvant-free Group
Adjuvant-free S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine,10μg/dose
干预措施: Haemophilus b Conjugate Vaccine (Biological)
Control Group
Haemophilus b Conjugate Vaccine,10μg/dose
干预措施: S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine (Biological)
结局指标
主要结局
incidence of adverse events during 30 days
时间窗: 30 day after each vaccination
Occurrence of adverse events during a 30 day follow-up period after each vaccination
Antibody positive rate
时间窗: 30 day after each vaccination
Percentage of participants with seroresponse to each vaccination
次要结局
未报告次要终点