A Phase IV Randomized, Controlled Study to Evaluate the Immunogenicity and Safety of Inactivated Japanese Encephalitis Vaccine in healthy volunteers. - JENVAC

Bharat Biotech International Ltd0 个研究点目标入组 500 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.Subjects of age 1 to <=65 years without significant medical history or abnormal clinical findings.
•2.Subject or Subjectâ??s Legally Acceptable Representative (LAR) who has been explained about all risks and benefits of the study and is willing to provide written informed consent.
•3.Agree to be available for all study related visits and procedures throughout the entire duration of the study.
•4.Individuals who are in good health as determined by the outcome of medical history, physical examination and based on the clinical judgement of the Principal Investigator.

•1.Subjects with age less than 1 year and more than 65 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 of the vaccine under study.
•4.Past history of JE vaccination.
•5.Life threatening or serious cardiac (NYHA grades III-IV heart failure), respiratory gastrointestinal, Hepatic, renal, Endocrine, hematological or immune disorders.
•6.Any confirmed or suspected immunosuppressive or Immunodeficient condition.
•7.Use of any marketed or investigational or herbal medicine or non-registered drug or vaccine for JE or other vaccine in the past 2months.
•8.Any criteria, which in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol.
•9.Previous history of hypersensitive reaction to vaccine or vaccine component.
•10.Women who are pregnant or breast-feeding.
•11.Married or sexually active participants who are not willing to follow effective birth control methods during the treatment period.
•12.Individuals participating in any other clinical trial within one month prior to study participation or intent to participate in any other clinical trial during the conduct of the study.

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