NCT02777411已完成2 期
An Open-label, Dose-finding, Phase II Study to Evaluate the Safety and Immunogenicity of EV71 Vaccine in Pediatric Subjects Aged 3 to 6 Years and 6 to 35 Months Old
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 4
- 主要终点
- Unsolicited adverse events
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 AlPO4 at 0.5-μg, 1-μg, 2-μg and 5-μg dose (if required) in children aged 3 to 6 years old and 0.25-μg (if required), 0.5-μg, 1-μg and 2-μg (if required) in 6 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
- 6 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; from 6 to 35 months old (i.e. ≥ 6 months old and < 36 months old) for Part B at the time of first vaccination.
- •Subject's guardians were able and willing to comply with study procedures and give written informed consent.
- •Subject was able and could 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, 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 bleeding difficulties with IM injections or blood draws.
- •Any acute infections 7 days prior to administrate 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 attenuated live vaccine within 7 days prior to vaccination.
- •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.
- •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
Unsolicited adverse events
时间窗: 28 days after each vaccination
Solicited adverse events
时间窗: 7 days after each vaccination
The occurrence of overall adverse events (AEs) and serious adverse event (SAEs)
时间窗: Day 0 to Day 196
次要结局
- immunoglobulin G (IgG) titers induced by the EV71 vaccine ( determined by ELISA)(Day 28, Day 56, Day 196)
- serum neutralizing antibody titers (NT) induced by the EV71 vaccine(Day 28, Day 56, Day 196)
- change in the laboratory results based on hematology tests in each visit(Day 28, Day 56, Day 196)
- change in blood pressures at each visit (for the 3 to 6 years old group only)(Day 28, Day 56, Day 196)
- Seroconversion rate (SCR) based on neutralizing antibody titers(Day 28, Day 56, Day 196)
- change in the laboratory results based on biochemistry tests in each visit(Day 28, Day 56, Day 196)
- change in heart rates at each visit (for the 3 to 6 years old group only)(Day 28, Day 56, Day 196)
研究者
研究点 (4)
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