NCT03268083已完成2 期
An Open-Label, Dose-Finding, Phase II Study to Evaluate the Immunogenicity and Safety of the Bioreactor-generated EV71 Vaccine in Pediatric Subjects Aged 3 to 6 Years and 2 to 35 Months Old
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 4
- 主要终点
- Seroconversion rate (SCR) based on neutralizing antibody titers
研究概览
简要总结
The objectives of this study are to evaluate the immune response and safety profiles of two injections of EV71 vaccine administrated with or without adjuvant Al(OH)3 at 0.5-μg and 1-μg dose in children aged 3 to 6 years old and 2 to 35 months old infants/toddlers.
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
- 2 Months 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy children aged from 3 to 6 years old (i.e. ≥ 3 years old and < 7 years old) for Part A,and from 2 to 35 months old (i.e. ≥ 2 months old and < 36 months old) for Part B at the time of first vaccination.
- •Subject's guardians are able and willing to comply with study procedures and provide the signed informed consent.
- •Subject is able and can comply with the requirements of the protocol.
- •Subject with body temperature ≤38°C.
排除标准
- •Subject with previous known exposure to Enterovirus 71 (EV71).
- •Subject with a history of herpangina, hand-foot-mouth disease,and acute hemorrhagic conjunctivitis associated with enterovirus infection in the past 3 months.
- •Subject with gestation < 37 weeks.
- •Subject with birth weight <2.5 kg.
- •Subject with a history of hypersensitivity to vaccines, or a history of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- •Family history of seizures or progressive neurological disease.
- •Family history of congenital or hereditary immunodeficiency.
- •Severe malnutrition or dysgenopathy.
- •Major congenital defects or serious chronic illness, including perinatal brain damage.
- •Subject diagnosed of having autoimmune disease (e.g., celiac disease, type I diabetes, lupus (SLE), juvenile dermatomyositis, scleroderma, juvenile idiopathic arthritis (JIA), immune (or idiopathic) thrombocytopenia purpura).
- •Bleeding disorder diagnosed by a doctor or significant bruising or hemostatic difficulties with IM injections or blood draws.
- •Any acute infections 7 days prior to administrating the first vaccination.
- •Use of any investigational product (including drug, vaccine) within 30 days prior to vaccination or planned use during the study period.
- •Administration of any vaccines within 14 days prior to randomization.
- •Use of immunoglobulins or any blood products within 3 months prior to vaccination or planned use during the study period.
- •Chronic administration (defined as > 14 days) of immunosuppressants or other immunomodulators or systemic corticosteroids within 6 months prior to vaccination or planned use during the study period.
- •Subjects who had ever received investigational EV-71 vaccine prior to randomization.
- •Under anti-tuberculosis prevention or therapy.
- •Any condition that in the opinion of the investigator may interfere with the evaluation of study objectives.
结局指标
主要结局
Seroconversion rate (SCR) based on neutralizing antibody titers
时间窗: Day 196
Evaluate the immunogenicity change of SCR from baseline on Day 196
Serum neutralizing antibody titers (NT) induced by the EV71 vaccine
时间窗: Day 196
Evaluate the immunogenicity change of serum neutralizing antibody titers induced by the EV71 vaccine from baseline on Day 196
次要结局
- Serum neutralizing antibody titers (NT) induced by the EV71 vaccine(Day 364)
- Unsolicited adverse events(28 days after each vaccination)
- Solicited adverse events(7 days after each vaccination)
- The occurrence of overall adverse events (AEs) and serious adverse event (SAEs)(Day 0 to Day 196)
- The occurrence of EV 71 breakthrough infection after Visit 3(Day 57 to Day 364)
研究者
研究点 (4)
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