CTRI/2020/04/024533
Completed
Phase 1
Phase I open label, clinical trial to evaluate the safety, tolerability and immunogenicity ofChikungunya vaccine in healthy adults of 18 to 50 years age - CHIKV40ug
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Bharat Biotech International limited
- Enrollment
- 20
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.\>\=18 and \<\=50 yrs inclusive on the day of screening
- •2\.Able and willing to complete informed consent process with understanding of the purpose and procedures of the study
- •3\.Medical history and physical examination without clinically significant findings at the time of screening.
- •4\.Hematological and biochemical values either within institutional normal range and accompanied by physician approval.
- •5\.Agree to keep a daily record of symptoms for the duration of the study
- •6\.Available for clinical followâ??up throughout the study period via telephone contact as well as clinic visits
- •7\.Female specific criteria:
- •a.If female of child bearing potential â?? have a negative urine pregnancy test result within 24 hrs of the scheduled first vaccination; (a woman who has not undergone permanent sterilization procedure, and has had 4 menstrual periods in last 12 months is considered as â??female of child bearing potential).
Exclusion Criteria
- •Female specific criteria:
- •Woman who is breast feeding or planning to become pregnant during the
- •study period.
- •General Criteria:
- •1\.History of suspected or confirmed Chikungunya fever.
- •(Case definition for Suspected Chikungunya:
- •A subject meeting both the clinical and epidemiological criteria.
- •2\.Clinical criteria: acute onset of fever \>38\.5°C and severe
- •arthralgia/arthritis not explained by other medical conditions.
- •3\.Epidemiological criteria: residing or having visited epidemic areas,
Outcomes
Primary Outcomes
Not specified
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