A Phase IV, single dose, openlabelled, comparative, randomized controlled study to evaluatethe immunogenicity and safety of BBILâ??s JENVAC (Inactivate JE Vaccine) vs. Chinese SA-14-14-2 (Live JE Vaccine) vaccine in healthy volunteers â?? Immunogenicity and safety followingbooster dose after 2 year. - JENVAC Single Dose Extension study

Bharat Biotech International Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Healthy volunteers of 1 to 15 years age group (inclusive) without significant medical history or abnormal findings at screening
•2.Parents/legal representative willing to give signed written Informed Consent.
•3.Available for all study related visits and procedures for the entire duration of the study, without any known exposure to JE prior to the first screening visit based on previous clinical history.

•1.Subjects with the age less than 1 year or more than 15 years.
•2.Fever of any origin of duration more than 3 days within one month prior to screening or on the day of screening.
•3.History of malaise, headache, anorexia at the time of screening or during the administration of the vaccine under study.
•4.Past history of JE infection.
•5.Life threatening or serious cardiac (NYHA grades III-IV heart failure), respiratory gastrointestinal, Hepatic, renal, Endocrine, haematological or immune disorders.
•6.History of allergic diseases.
•7.Any confirmed or suspected immunosuppressive or immunodeficient condition
•8.Use of any marketed or investigational or herbal medicine or non-registered drug or vaccine for JE or other vaccine in the past 2 months.
•9.Previous history of hypersensitive reaction to vaccine or vaccine component.

发起方