JPRN-UMIN000000471已完成2 期
A confirmatory trial of BK-PIFA in healthy volunteers. - BK-PIFA/002
ational Hospital Organization Mie National Hospital0 个研究点目标入组 300 人开始时间: 2006年9月4日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 65years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1. Defined history of H5N1 avian flu ( gived subjects ) 2. Previously H5 avian flu vaccinated ( gived subjects ) 3. Subjects who has induced anaphylaxis by substance of foods and drugs. 4. Any cllinically significant history of heart, vasculature, blood systems, respiratory, liver, kidney, digestive, neuropsychiatric disorder. 5. History of Guillain- Barre Syndrome and Acute-disseminated-encephalomyelitis. 6. Participation in any clinical trial within 4months. 7. Previous treatment for livevaccine within 27days, or inactivated vaccine( without influenza vaccine HA vaccine)/toxoid within 6days. 8. Previously influenza vaccine HA vaccine within 4months. 9. History of blood transfusion or gamma-globulin preparations within 3months, or massive dose therapy of gamma-globulin preparations (greater or equal 200 mg/kg ) within 6months. 10. Pregnant and probably pregnant subjects. 11. Others judged as being inappropriate for the subjects of the study by investigators.
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