NCT03893747已完成4 期
Three Batches Consistency, Immunity Duration and Safety of Inactivated Enterovirus 71 Vaccine Post-marketing Among Children Aged 6-35 Months in China
Jiangsu Province Centers for Disease Control and Prevention1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2019年4月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Incidence and severity of adverse reactions/adverse events after each dose
研究概览
简要总结
This study evaluates three batches consistency, immunity duration and safety of inactivated Enterovirus 71(EV-A71) vaccine(vero cell) post-marketing among children aged 6-35months in China.3000 subjects will be recruited in this study, of who 1500 subjects will be randomly assigned in a ratio of 1:1:1 to receive one of the three batches of EV-A71 vaccines manufactured by 40L capacity reactor, other 1500 subjects will be randomly assigned in a ratio of 1:1:1 to receive one of the three batches of EV-A71 vaccines manufactured by 150L capacity reactor. Vaccine wil be administrated according to a two doses of schedule given at day 0 and 28. Sample will be collected at day 0, day 56 and at month 13 after vaccinaiton.
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
- 6 Months 至 35 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy children aged 6-35 months
- •Subjects who have been clinically judged to be healthy by the researcher after being asked about the medical history and related physical examination
- •The subjects' guardians agree the requirements of the protocol and the relevant follow up visits
- •The subjects' guardians agree and sign the informed consent
- •Subjects who have no relocation or long-term travel plan within one year and are able to comply with the requirements of the clinical trial protocol.
排除标准
- •Subject who has a medical history of HFMD caused by EV71 or has been vaccinated with EV71 vaccine
- •Subject that has a history of allergies to vaccines or vaccine ingredients, and has serious side effects on vaccines, such as allergies, urticaria, dyspnea, vascular neuroedema or abdominal pain
- •Subject who has congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
- •Subject who has a history of epilepsy, convulsion or convulsion, or a family history of mental illness
- •Subject who has autoimmune disease or immune deficiency, or whose parents and siblings have autoimmune disease or immune deficiency
- •Subject who has a history of asthma, vascular and neuroedema, diabetes or malignant tumor
- •Subject who has a thyroid resection history, or received treatment due to thyroid disease in the past 12 months
- •Subject who has an abnormal coagulation function (such as coagulation factor deficiency, coagulant disease, platelet abnormality) or obvious bruising or clotting disorder which was diagnosed by doctors.
- •Asplenia, functional asplenia, or splenectomy due to any circumstances
- •Acute onset of various acute or chronic diseases in the last 7 days
- •Immunosuppressant therapy, antiallergic therapy, cytotoxicity therapy, inhaled corticosteroids (excluding corticosteroid spray therapy for allergic rhinitis, surface corticosteroid therapy for acute non-dermatitis) in the past 6 months
- •Any prior administration of blood products in last 3 months
- •Any prior administration of other research medicines or vaccines in last 1 month
- •Any prior administration of attenuated live vaccine in last 15 days
- •Any prior administration of subunit or inactivated vaccines in last 7 days
- •Under the anti-TB prevention or therapy
- •Underarm temperature > 37.0 ℃ for fever before vaccination
- •Other factors that are not suitable for clinical trials according to the judgment of researchers
- •Exclusion Criteria for the second dose:
- •Have severe allergic reaction after first dose
- •Have severe adverse reactions related to first dose
- •Any situation meet the exclusion criteria stated in the exclusion criteria for first dose
- •Acute infection or illness
- •Other factors that are not suitable for clinical trials according to the judgment of researchers
结局指标
主要结局
Incidence and severity of adverse reactions/adverse events after each dose
时间窗: 1 month after each dose
Incidence and severity of adverse reactions/adverse events within 1 month after each dose
Consistency of different batches for geometric mean titre(GMT) after vaccination
时间窗: 56 days after vaccination
Consistency of different batches for GMT of EV-A71 neutralizing antibody on 56 day after vaccination
次要结局
- Positive rate of EV-A71 neutralizing antibody on day 56 after vaccination(56 days after vaccination)
- GMTof EV-A71 neutralizing antibody on month 13 after vaccination(13 months after vaccination)
- Positive rate of EV-A71 neutralizing antibody on month 13 after vaccination(13 months after vaccination)
- GMTof EV-A71 neutralizing antibody on day 56 after vaccination(56 days after vaccination)
- Geometric Mean Fold Increase(GMFI) of EV-A71 neutralizing antibody on day 56 after vaccination(56 days after vaccination)
- Incidence of sever adverse events after vaccination(13 months after vaccination)
- Seroconversion rate of EV-A71 neutralizing antibody on day 56 after vaccination(56 days after vaccination)
研究者
研究点 (1)
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