A phase1 study of Hydroxypropyl-beta-cyclodextrin(HP-beta-CyD)-adjuvanted influenza split vaccine - A phase1 study of Hydroxypropyl-beta-cyclodextrin(HP-beta-CyD)-adjuvanted influenza split vaccine

Osaka University hospital0 个研究点目标入组 36 人开始时间: 2017年9月1日最近更新: 2023年10月17日

适应症

试验速览

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•1.having following disease and not controlled despite the medication;cardiac disease,renal disease,hepatic disease,hematologic disease,autoimmune disease or developmental disorder. 2.any history of seasonal influenza in the past 6 months 3.any seasonal vaccination in the past 6 months 4.any scheduled to any other vaccination during this trial 5.any history of anaphylaxis to food, medicine or vaccine 6.any history of anaphylaxis or any likely to allergic reaction to components of test drug,egg,chicken,or other element derived from fowl 7.any history of following disease:acute disseminating encephalomyelopathy,Guillain Barre syndrome,thrombocytopenic purpura, thrombocytopenia, vasculitis, encephalopathy/encephalitis, myelitis, Stevens Johnson syndrome, or nephrotic syndrome 8.administration with any live vaccine in the past 27 days 9.administration with any inactivated/toxoid vaccine in the past 6 days 10.any history of having a blood transfusion or administration with gamma globulin in the past 3 months 11.any history of administration with more than 200 mg/kg of gamma globulin in the past 6 months 12.administration with any investigative drug in the past 4 months in clinical trials 13.no intention to prevent pregnancy during this clinicaltrial 14.being judged as inadequate for joining the clinical trial by investigators

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