CTRI/2010/091/000082已完成1 期
A Phase I clinical trial to assess safety of the Influenza Vaccine (whole virion, Inactivated) A/H1N1 (Pandemic) in Adults
Serum Institute of India Limited SII0 个研究点目标入组 50 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
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
入选标准
- •Inclusion Criteria:
- •1) Normal healthy subjects of 18-49 years age at the time of screening. 2)Free of obvious health problems.
排除标准
- •1.Have a known allergy to eggs or other components of the vaccine. 2.Pregnancy 3. Participating in other clinical trial during the present trial period 4. Acute febrile illness or acute infectious disease 5.History of a previous severe allergic reaction. 6. History of H1N1 Influenza infection or any influenza vaccination. 7. Positive serology for HIV antibody, HCV antibody or Hepatitis B surface antigen. 8.History of Guillain-Barré Syndrome. 9. Known history of a bleeding disorder
研究者
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