NCT01040078Unknown3 期
Novel Influenza A/H1N1 Split- Virion Vaccine in Healthy Children Aged 6 to 35 Month
Centers for Disease Control and Prevention, China3 个研究点 分布在 1 个国家目标入组 900 人开始时间: 2009年12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
- 900
- 试验地点
- 3
研究概览
简要总结
The purpose of this study is to generate data on immunogenicity and safety of the monovalent H1N1 vaccine in support of the development and registration.
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
- Double (Participant, Investigator)
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
- •Male or female aged >= 6 months to =<35 months at the time of the first study vaccination. Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg
- •Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative Subject and parent/legal representative are able to attend all scheduled visits and to comply with all trial procedures
排除标准
- •Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination
- •Planned participation in another clinical trial during the present trial period
- •Receipt of any vaccine in the 4 weeks preceding the first trial vaccination
- •Planned receipt of any vaccine prior to the Day 42 blood sample
- •Receipt of blood or blood-derived products in the past 3 months which might interfere with the assessment of immune response
- •Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
- •Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances
- •Thrombocytopenia contraindicating intramuscular (IM) vaccination as reported by parents/legal representative
- •Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion contraindicating IM vaccination
- •Chronic illness that in the opinion of the Investigator is at a stage where it might interfere with trial conduct or completion
- •Family members of the employees or the Investigator
- •Previous participation in a trial investigating a vaccine with the swine-origin A/H1N1 influenza strain
- •Confirmed infection with the novel influenza A/H1N1 strain
- •Febrile illness (temperature ≥ 38.0°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment
研究者
研究点 (3)
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