NCT01738074Unknown3 期
Phase Three Clinical Trials of Trivalent Rotavirus Genetic Reassortment Vaccine
Center for Disease Control and Prevention, Henan Province0 个研究点目标入组 10,020 人开始时间: 2012年8月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 10,020
- 主要终点
- Antibody titer differences in serum
研究概览
简要总结
Assessment and evaluation the rotavirus gastroenteritis prevention effect and severe rotavirus diarrhea reducing effectiveness of human body, which inoculate trivalent rotavirus genetic reassortment vaccine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 6 Weeks 至 13 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •6 to 13 weeks aged healthy baby;
- •Guardian volunteer to participate in the study and sign informed consent;
- •have use thermometer as required and the ability to fill in the diary table;
- •Subjects guardian can abide by the requirements of clinical research scheme;
- •The past has not been vaccinated rotavirus vaccine;
- •Normal term eutocia, birth weight up to standard;
- •Axillary temperature is 37.0 ℃ or less.
排除标准
- •With allergy, convulsion, epilepsy, encephalopathy and spirit history or the family history;
- •Be allergy to any ingredients in the vaccine;
- •Known immunology function damage or low person;
- •Immunosuppressant therapy Accepter;
- •Suffering from congenital malformation and developmental disorder;
- •Known or suspected also suffer from diseases including: digestive system disease, respiratory system disease, acute infection, mother or I have HIV infection, cardiovascular diseases, malignant tumor during treatment, skin disease;
- •Inoculation other vaccine within 7 days.
结局指标
主要结局
Antibody titer differences in serum
时间窗: 4 weeks after full vaccination
Incidence differences of rotavirus diarrhea
时间窗: 2 years after full vaccination.
次要结局
未报告次要终点
研究者
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