NCT01273246已完成1 期
A Blind, Randomized and Placebo-controlled Clinical Trial With Inactivated Enterovirus Type 71 Vaccines in Healthy Children.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- To evaluate the safety of the inactivated Enterovirus Type 71 Vaccine
研究概览
简要总结
A Phase I clinical trialto evaluate the safety of an Inactivated Enterovirus Type 71 Vaccine in healthy children (3-11y) and infants (6-35m).
详细描述
36 eligible children aged from 3 to 11 years and 96 eligible infants aged from 6 to 35 months will be enrolled in the study, they will be randomized to receive different dosage of vaccine candidate or placebo to evaluate the safety of this vaccine
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, Care Provider)
入排标准
- 年龄范围
- 6 Months 至 11 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.
- •Birth weight more than 2500 grams
排除标准
- •Histroy 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 28 days
- •Administration of subunit or inactivated vaccines ,e.g., pneumococcal vaccine, or allergy treatment within 14 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
To evaluate the safety of the inactivated Enterovirus Type 71 Vaccine
时间窗: 6 months
All adverse events were records. Blood cell and biochemistry were performed.
次要结局
- To evaluate the immunogenicity of the inactivated Enterovirus Type 71 Vaccine(6 months)
研究者
研究点 (1)
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