An open label phase-IV, label expansion study to evaluate the safety and immunogenicity of BEâ??s licensed Inactivated vero cell based Japanese Encephalitis Vaccine in â?¥3 to 18 year old Indian children & adolescents in a two dose (0, 28D) schedule. - None

Biological E Limited0 个研究点目标入组 108 人开始时间: 待定最近更新: 2021年11月24日

研究概览

暂无简介。

•1.Indian subjects of either sex between >=3 to <18 years at the time of 1st vaccination.
•2.Free from clinically significant health problems as established by medical history and protocol specified clinical laboratory tests before entering into the study as judged by the Investigator.
•3.Written informed consent obtained prior to screening from subject, subjectâ??s parent/guardian or his/her legally acceptable representative. An assent will also be obtained for children and adolescents (>=10 years to <18 years) where applicable prior to screening.
•4.Ability of the subject, subjectâ??s parent/guardian or his/her legally acceptable representative to understand and comply with the requirements of the protocol.
•5.Female subjects with either no childbearing potential or, if after onset of menarche, a negative pregnancy test and a willingness to practice a reliable method of contraception.
•6.Acceptable methods of birth control included barrier methods (including male and female condoms), diaphragms (cervical caps) with intra-vaginal spermicide (including jellies, foams and suppositories), intra-uterine devices, hormonal contraceptives, abstinence or same sex relationships.

•1.History of vaccination against Japanese encephalitis (JE), Yellow fever and Dengue fever
•2.Planned administration of any other study vaccine during the study period.
•3.Any family history of Immunodeficiency or autoimmune disease.
•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, HBV and HCV.
•6.Subjects with history of severe uncontrolled diabetes/ cardiopulmonary/hepatobiliary / renal disorders and or malignancy.
•7.Any acute infection within two weeks prior to enrolment.
•8.Drug addiction within 3 months prior to enrolment (including alcohol dependence, i.e. more than approx. 60 mL of alcohol per day, or conditions which might interfere with the study conduct).
•9.Pregnancy (positive urine pregnancy test during screening), lactation or unreliable contraception in female subjects after onset of menarche.
•10.Subjects with any condition which in the opinion of the investigator makes the subject unsuitable for inclusion.

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