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Clinical Trials/CTRI/2020/02/023128
CTRI/2020/02/023128
Completed
Phase 4

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 sites500 target enrollmentTBD
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Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Not specified
Sponsor
Bharat Biotech International Ltd
Enrollment
500
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •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.

Exclusion Criteria

  • •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.

Outcomes

Primary Outcomes

Not specified

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