NCT01098786已完成不适用
Observational Study to Evaluate Safety of Cell-derived A/H1N1 Influenza HA Vaccine in Healthy Japanese Subjects
Novartis Vaccines1 个研究点 分布在 1 个国家目标入组 556 人开始时间: 2010年2月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 556
- 试验地点
- 1
- 主要终点
- Evaluate clinical symptoms according to the subject background after vaccination
研究概览
简要总结
This is to evaluate safety of cell-derived A/H1N1 influenza HA vaccine in healthy Japanese subjects.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Japanese
排除标准
- •The person has received any other company's new influenza vaccine (swine-derived A/H1N1) before vaccination with this product.
- •The person has participated in any clinical study of this product or any other company's new influenza vaccine (swine-derived A/H1N1) and received the investigational vaccine.
- •The person is regarded as a subject in one of the following items 3) to 6) who is not appropriate to receive preventive vaccination as described in the current package insert.
- •The person shows obvious fever.
- •The person obviously suffers from serious acute disease.
- •The person has obviously shown anaphylaxis due to an ingredient of this vaccine.
- •The person is otherwise in an inappropriate state to receive preventive vaccination.
结局指标
主要结局
Evaluate clinical symptoms according to the subject background after vaccination
时间窗: 28 days
次要结局
- The kinds, degrees, durations and onset ratios of adverse events(28 days)
研究者
研究点 (1)
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