Immunogenicity and Safety of Three Consecutive Lots of a New Inactivated Enterovirus Type 71 (EV71) Vaccine: A Double-blind, Randomized and Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,400
- 试验地点
- 1
- 主要终点
- The GMT of anti-EV71 antibodies in serum 28 days after the two-dose regimen
研究概览
简要总结
The purpose of this study is to evaluate the immunogenicity and safety of three consecutive lots of EV71 Vaccines in healthy infants volunteers aged from 6 months to 5 years old.
详细描述
The data from the phase I and II study suggested that the inactivated EV71 vaccine (vero cell) had a clinically acceptable safety and good immunogenicity for healthy Chinese infants. The phase III study of inactivated vaccine has initiated on Jan 2012 in China. Over 10,000 healthy infants have revieved the vaccines and no unexpected severe adverse reactions were reported. According to the requirement of SFDA (China), the sponsor should also provide the evidence for the consistency of three consecutive lots of EV71 Vaccines before the application for the market. Thus, a clinical trial to evaluate the immunogenicity and safety of three consecutive lots of EV71 Vaccines in healthy infants volunteers is planed to conduct.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 6 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males and females, aged from 6 months to 11 years old Health is determined by medical history, physical examination, laboratory examination and clinical judgment of the investigator
- •Provided legal identification for the sake of recruitment
- •Subjects and/or parent(s)/legal guardian(s) are able to understand and sign informed consents
排除标准
- •History of Hand-foot-mouth Disease
- •Subject that has allergic history of vaccine, or allergic to any ingredient of vaccine
- •Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
- •Congenital malformations or developmental disorders, genetic defects, or severe malnutrition
- •Epilepsy, seizures or convulsions history, or family history of mental illness
- •Autoimmune disease or immunodeficiency, or parents, brothers and sisters have autoimmune diseases or immunodeficiency
- •History of asthma, angioedema, diabetes or malignancy
- •History of thyroidectomy or thyroid disease that required medication within the past 12 months
- •Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws
- •Asplenia, functional asplenia or any condition resulting in the absence or removal the spleen
- •Acute illness or acute exacerbation of chronic disease within the past 7 days
- •Any history of immunosuppressive medications or cytotoxic medications or inhaled corticosteroids within the past six months (with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis)
- •History of any blood products within 3 months
- •Administration of any live attenuated vaccine within 14 days
- •Administration of subunit or inactivated vaccines ,e.g., pneumococcal vaccine, or allergy treatment within 7 days
- •Axillary temperature > 37.0 centigrade before vaccination
- •Abnormal laboratory parameters before vaccination
- •Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent
结局指标
主要结局
The GMT of anti-EV71 antibodies in serum 28 days after the two-dose regimen
时间窗: 28 days after first vaccination
to evaluate the immunogenicity of anti-EV71 antibodies in serum 28 days after second vaccination
次要结局
- Frequency of systemic and local adverse reactions after the first vaccination(28 days after the first vaccination)
- Frequency of systemic and local adverse reactions after the second vaccination(28 days after the second vaccination)