CTRI/2010/091/000008已完成1 期
A Phase I clinical trial to assess safety of the Pandemic influenza vaccine (Human, live attenuated) A (H1N1) 2009 of SIIL in Adults
Serum Institute of India Limited0 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
- •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. Altered immune status 5. Acute febrile illness or acute infectious disease or had acute respiratory illness in the previous 7 days. 6. Subject with nasal pathology, History of allergic rhinitis, asthma or administration of any intranasal medication. 7. History of a previous severe allergic reaction. 8. History of H1N1 Influenza infection or any influenza vaccination. 9. Positive serology for HIV antibody, HCV antibody or Hepatitis B surface antigen.10. History of Guillain-Barré Syndrome.
研究者
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