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临床试验/CTRI/2012/04/002604
CTRI/2012/04/002604已完成2 期

A Phase II/III clinical trial to assess safety and immune response of Trivalent, Live Attenuated Seasonal Influenza vaccine of SIIL in Adults, Elderly and Pediatric Populations

Serum Institute of India Ltd0 个研究点目标入组 290 人开始时间: 待定最近更新:

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
290

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 appropriate age (pediatric 2-17 years; adult 18-49 years; elderly >= 50 years 2.Free of obvious health problems as established by medical history, and physical examination. 3. A woman of child bearing age potential must agree not to become pregnant and a man must agree not to conceive a child during his/her study participation.

排除标准

  • 1. Confirmed/suspected influenza infection or any influenza vaccination.2. Have a known allergy to eggs. 3. Pregnancy and breastfeeding women 4. Subject participating in other clinical trial 5. Altered immune status. 6. Acute febrile illness or acute infectious disease. 7. Any nasal pathology. 8. Asthma with recurrent wheezing. 9. History of allergic reaction. 10. History of serious chronic illness. 11. H/o Guillain-Barré Syndrome. 12. children or adolescents receiving aspirin therapy in the previous 7 days. 13. Major congenital defects

研究者

发起方
Serum Institute of India Ltd

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