A single centre open label phase-1 study to evaluate the Safety and Reactogenicity of BEs Inactivated JE vaccine in greater than or equal to 18 to 49 year old healthy adult male subjects. - None

Biological E Limited0 个研究点目标入组 20 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•Healthy Indian adult male subjects between greater than or equal to 18 to <49 years of age.
•-Free of significant health problems as established by medical history and clinical laboratory tests before entering into the study.
•-Written informed consent obtained prior to screening from Subjects or their legally acceptable representative.
•-Ability of the volunteer or his legally acceptable representative to understand and comply with the requirements of the protocol.

•-History of vaccination against Japanese encephalitis (JE), Yellow fever and Dengue fever.
•-Inability or unwillingness to abide by the requirements of the study
•-Use of any investigational or non-registered drug or vaccine other than the study vaccine during the study period or within 30 days preceding the first dose of study vaccine.
•-Any acute infection at the time of 1st vaccination.
•-History of severe hypersensitivity reactions (in particular to a component of the investigational vaccine, anaphylaxis or severe cases of atopy requiring emergency treatment or hospital admission).
•-Volunteers with history of type-I diabetes, severe cardiopulmonary disorders, hepatobiliary / renal disorders and malignancy
•-Subjects with any condition which in the opinion of the investigator makes the subject unsuitable for inclusion.

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