A Phase II/III, Randomized, Single Blinded, Active Controlled Study to Evaluate the Immunogenicity and Safety of Inactivated Japanese encephalitis Vaccine in healthy volunteers - JENVAC

Bharat Biotech Intl Ltd0 个研究点目标入组 600 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.Healthy volunteers of 50 to 1 years age group (inclusive) without significant medical history or abnormal findings at screening
•2.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 and above 50 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, head ache, 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, hematological or immune disorders.
•6.Past history of / current 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.Clinically relevant abnormal hematology or biochemistry values in the opinion of the investigator.
•10.Any criteria, which in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol.
•11.Intention to travel out of the area prior to final or follow-up
•Visit on day 56±2.
•12.Previous history of hypersensitive reaction to vaccine or
•Vaccine component.

发起方

Bharat Biotech Intl Ltd