None listed
Conditions
Interventions
Intervention1: Typbar TCV: Visit 1: (Day 0+3days)
Subjects between agesâ?¥18 to â?¤65 years will be screened as per the eligibilty criteria, after obtaining written informed consent. Screening procedu
Sponsors
Bharat Biotech International Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Subjects of age >=18 to 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 Agree to be available for all study related visits and procedures throughout the entire duration of the study. Female subjectâ??s of child bearing potential must demonstrate a negative urine pregnancy test at the time of screening. 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
Exclusion criteria: Subjects with age less than 18 years and more than 65 years. Fever of any origin or duration for more than 3 days prior to intended study immunization Past history of Typhoid infection. History of any illness or any laboratory abnormality that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study Individuals with any serious chronic or progressive diseases according to the judgment of Investigator (eg: neurological, neoplasm, insulin-dependent diabetes, hepatic, renal, cardiac diseases). Any confirmed or suspected use of immunosuppressive drugs or Immuno deficient condition. Use of any marketed/investigational/herbal medicine or non-registered drug or vaccine for Typhoid. Any criteria, which in the opinion of the investigator, suggests that the subject may not be compliant with the study protocol. History of allergy or allergic reactions to the vaccine or any vaccine component. Women who are pregnant or breast-feeding or of childbearing age. Married or sexually active participants who are not willing to follow effective birth control methods for at least 3 months after vaccine. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects attaining seroconversion ( four-fold rise in anti-salmonella typhi Vi polysaccharide IgG antibody titre compared to baseline), 28±2 days after vaccine administration Compare GMT and Seroconversion at Day 0 and Day 28 Timepoint: Day 0 and Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of solicited local and systemic adverse events, unsolicited adverse events and proportion of subjects with Serious Adverse EventsTimepoint: Day 0 and Day 28 | — |
Countries
India
Contacts
Public ContactDr V Krishna Mohan
Bharat Biotech International Limited
Outcome results
None listed