Trial of immunogenicity of a monovalent influenza A (H1N1) 2009 vaccine

ational Hospital Organization Headquarters0 个研究点目标入组 200 人开始时间: 2010年1月4日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1)Subjects aged 20 years or older at the time of getting informed consent.
•2)Pregnant women were permitted after permission by obstetricians or gynecologists.
•3)Subjects, who were able to follow the regulation of the trial, have clinical examination written in the protocol and report their symptoms.

•1)Subjects with the history of Swine Influenza A (H1N1) infection. (obtained by subjects)
•2)Subjects vaccinated with Swine Influenza A (H1N1) vaccine previously (obtained by subjects).
•3)Subjects, who had history of anaphylaxy to foods or medicines previously.
•4)Subjects with severe diseases in cardiovascular, blood, respiratory, liver, kidney, digestive or neurological systems in their clinical recording.
•5)Subjects with a history of acute disseminated encephalomyelitis and Guillain-Barre syndrome in the past.
•6)Subjects aged 75 years or older living alone, or suffered from dementia and unable to have their consent.
•7)Subjects participated in a clinical trial with influenza vaccine within four months (counted from the date of vaccination).
•8)Subjects vaccinated with live vaccine within 27 days, or received a dose of inactivated vaccine within six days (counting from the date of vaccination).
•9)Subjects 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 (counting from the date of vaccination).

发起方

ational Hospital Organization Headquarters