None listed
Conditions
Interventions
Intervention1: Typbar TCV: Typhoid Conjugate Vaccine
A single dose of 0.5 ml of Typbar TCV® will be administered intramuscularly in the deltoid region of the arm ON Day 0
Control Intervention1: No com
Sponsors
Bharat Biotech International Limited
Eligibility
Inclusion 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 the Principal Investigator.
Exclusion criteria
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 diseases). 7. Any confirmed or suspected use of immunosuppressive drugs or immunodeficient condition. 8. Use of any marketed/investigational/herbal medicine or non-registered drug or vaccine for Typhoid. 9. Any criteria, which in the opinion of the investigator, suggests that the subject may not be compliant with the Trail protocol. 10. History of allergy or allergic reactions to vaccine or any vaccine component 11. Women who are pregnant or breast-feeding. 12. Married or sexually active participants who are not willing to follow effective birth control methods for at least 3 months after vaccine. 13. Individuals participating in any other clinical trial within one month prior to Trail participation or intent to participate in any other clinical trial during the conduct of the Trail
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. 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 2. Anti-Vi IgG GMT will be assessed on Day 0 and Day 28±2. Timepoint: Day 0 and Day 28±2. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Occurrence of solicited local and systemic adverse events, unsolicited adverse events and proportion of subjects with Serious Adverse EventsTimepoint: 1.30 minutes after vaccination 2.Till 7 days 3.Throughout the study period | — |
Countries
India
Contacts
Public ContactDr V Krishna Mohan
Bharat Biotech international limited
Outcome results
None listed