Efficacy and safety of the avian influenza A/H7N9 inactivated whole-virus vaccine produced using the embryonated egg in human (Investigator-initiated Phase 2b trial) - Efficacy and safety of the avian influenza A/H7N9 inactivated whole-virus vaccine produced using the embryonated egg in human (Investigator-initiated Phase 2b trial)(H7N9BK_P2b)

Clinical Research Center, National Hospital Organization0 个研究点目标入组 105 人开始时间: 2016年8月23日最近更新: 2023年10月17日

适应症

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•1)Individuals with the history of Avian Influenza A (H7)virus infection.(obtained from subjects) 2)Individuals, who had history of anaphylaxis to foods or medicines previously. 3)Individuals with severe diseases in cardiovascular, blood, respiratory, liver, kidney, digestive or neurological systems in their clinical recording. 4)Individuals with a history of acute disseminated encephalomyelitis and Guillain-Barre syndrome in the past. 5)Individuals participated in a clinical trial within four months(counted from the date of vaccination). 6)Individuals vaccinated with live vaccine within 27 days, or received a dose of inactivated vaccine within six days(including the day of vaccination). 7)Individuals received with gamma globulin or blood transfusion within three months, or received the formulation of high dose of gamma globulin therapy (200 mg/kg or more) within six months (including the day of vaccination). 8)From the day of the first administration to the last day of follow-up , Individuals or partners, who wish to become pregnant, and Individuals, who could not perform the appropriate method of contraception. 9)A breast-feeding women, a pregnant women or a suspected pregnancy woman. 10)Individuals, who are deemed to be inappropriate by the investigator.

发起方

Clinical Research Center, National Hospital Organization