A Multicentric open label non-interventional post marketing Surveillance study to evaluate safety and tolerability of BEâ??s inactivated vero cell derived Japanese Encephalitis vaccine in â?¥1 to â?¤3 year old healthy children in a two dose schedule. - None

Biological ELimited0 个研究点目标入组 800 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。

•1.Subjects of either sex who are between >=1 to <=3 years at the time of 1st vaccination
•2.Written informed consent obtained prior to screening from subjectâ??s Parents/Guardian or the legally acceptable representative (LAR)
•3.Free of clinically significant health problems as established by medical history and physical examination before entering into the study
•4.Ability of the subjectâ??s Parents/Guardian or the legally acceptable representative (LAR) to understand and comply with the requirements of the protocol

•1.Use of any other investigational or non-registered drug or vaccine in addition to the study vaccine during the study period or within 30 days preceding the first dose of study vaccine.
•2.Any family history of Immunodeficiency or autoimmune disease.
•3.Administration of chronic (defined as more than 14 days) immune-suppressants or other immune-modifying drugs within 6 months of vaccination. (For corticosteroids, this meant prednisone, or equivalent, >=0.05 mg/kg/day. Topical and inhaled steroids allowed).
•4.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).
•5.Any confirmed or suspected Infection with HIV, HCV and Hepatitis B (HBsAg).
•6.Subjects with history of severe cardiopulmonary, hepatobiliary / renal disorders and or malignancy.
•7.Any acute infection within two weeks prior to enrolment.
•8.Inability or unwillingness by the subjectâ??s parent/guardian or legally acceptable representative(s) to provide informed consent and to abide by the requirements of the study.
•9.Any condition which in the opinion of the investigator makes the subject unsuitable for inclusion.

发起方

Biological ELimited