NCT01812135撤回2 期
A Double-blind and Randomized, Phase II -02 Study With Inactivated EV71 Vaccines in Healthy Infants
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Neutralization antibody geometric mean titer in infants 28 days after immunization with 400U vaccine with or without aluminium hydroxide adjuvant
研究概览
简要总结
A randomized, double-blind, phase II-02 clinical trial is to evaluate the safety and immunogenicity of an inactivated EV71 vaccine with or without aluminum adjuvant
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 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males and females, aged from 6 to 11 months 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
- •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 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
研究组 & 干预措施
Group 1: 400U EV71 vaccine without adjuvant
Experimental
60 infants received 2 doses of 400U EV71 vaccine without aluminium hydroxide adjuvant 28 days apart
干预措施: 400 U EV71 vaccine with adjuvant (Biological)
Group 2: 400U EV71 vaccine without adjuvant
Experimental
60 infants received 1 doses of 400U EV71 vaccine without aluminium hydroxide adjuvant
干预措施: 400 U EV71 vaccine with adjuvant (Biological)
Group 3: 400U EV71 vaccine with adjuvant
Experimental
60 infants received 1 doses of 400U EV71 vaccine with aluminium hydroxide adjuvant
干预措施: 400 U EV71 vaccine with adjuvant (Biological)
结局指标
主要结局
Neutralization antibody geometric mean titer in infants 28 days after immunization with 400U vaccine with or without aluminium hydroxide adjuvant
时间窗: 2 months
Primary immunogenicity end point were geometric mean titer of neutralization antibody againt EV71 virus \>= 1:8
次要结局
- The rates and severity of solicited and unsolicited adverse events in infants following immunization as a Measure of Safety and Tolerability(2 months)
研究者
研究点 (1)
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