CTRI/2024/06/069638
Not yet recruiting
Phase 3
A Phase III Open-label Study to Evaluate the Immunogenicity and Safety of Typhoid Tetanus Toxoid Conjugate Vaccine, Typbar TCV® in Adults (greater than 65 Years). - Typbar-TCV
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Bharat Biotech International Limited
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Subjects of age \=18 without significant medical history or abnormal
- •clinical findings
- •2\. Subject who has been explained about all risks and benefits of the
- •Trail and is willing to provide written informed consent.
- •3\. Agrees to be available for all Trail related visits and procedures
- •throughout the duration of the Trail.
- •4\. Female subjects of child bearing potential must demonstrate a negative
- •urine pregnancy test at the time of screening.
- •5\. Individuals who are in good health as determined by the outcome of
- •medical history, physical examination and based on clinical judgement of
Exclusion Criteria
- •1\. Subjects who are under the age of 18 years
- •2\. Fever of any origin or duration for more than 3 days prior to intended Trail immunization
- •3\. History of Typhoid vaccination in the last 5 years
- •4\. History of Typhoid disease in the last 5 years
- •5\. History of any illness or any laboratory abnormality that, in the opinion of the investigator, might
- •interfere with the results of the Trail or pose additional risk to the subjects due to participation
- •in the Trail
- •6\. Individuals with any serious chronic or progressive diseases according to the judgment of
- •Investigator (eg: neurological, neoplasm, insulin dependent diabetes, hepatic, renal, cardiac
- •7\. Any confirmed or suspected use of immunosuppressive drugs or immunodeficient condition.
Outcomes
Primary Outcomes
Not specified
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