None listed
Conditions
Interventions
Intervention1: Typhoid Vi Conjugate Vaccine I.P. of
M/s. Cadila Healthcare Ltd. (ZyVac
TCV): subject will receive a single dose of 0.5 ml of ZyVac TCV. The vaccine will
be administered as intramuscula
Sponsors
Cadila Healthcare Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy subjects of either gender �6 months to �45 years of age at the time of enrollment 2. Subjects should be in a good health as determined by the medical history and physical examination based on clinical judgment of the investigator 3. No previous history of vaccination (oral or injectable) against typhoid fever 4. Informed consent from the adult subjects or from the parents of pediatric subjects. Additionally, assent from pediatric subjects aged 7 years or more 5. Adult subjects or parents of pediatric subjects literate enough to fill the diary card 6. Adult subjects or, pediatric subjects and their parents intend to be available for follow-up for entire duration of the study
Exclusion criteria
Exclusion criteria: 1. History of hypersensitivity reaction to any component of the vaccine 2. History of laboratory confirmed or suspected typhoid fever in the past 3 years 3. Subject who have had household contact with/ and/or intimate exposure to an individual with laboratory confirmed S. typhi 4. Fever of any origin or infectious disorder of 3 days or more within the past month 5. Febrile illness (body temperature â�¥ 37.5�°C) at the time of enrollment 6. History of any vaccination within the past month 7. History of COVID-19 within the past 3 months 8. Clinically significant systemic disorder such as cardiovascular, respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, hematological or immunological disorder 9. Confirmed or suspected immunosuppressive or immunodeficiency disorder; or subjects on any immunosuppressive or immunostimulant therapy 10. Known case of thrombocytopenia or any coagulation disorder, or subjects on anticoagulation therapy 11. Subjects administered blood, blood containing products or immunoglobulins within the last 3 months or planned administration during the study 12. Pregnant and lactating women & female subjects not using acceptable contraceptive measures (double barrier methods, oral or injectable hormonal contraceptives or surgical sterilization) 13. Subject participated in another clinical study in the past 3 months or subject intend to participate in another clinical study within 3 months following intended study vaccine administration 14. Subject with history of alcohol or drug abuse in the past one year 15. Any other reason for which the investigator feels that subject should not participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events reportedTimepoint: Throughout the study duration | — |
Secondary
| Measure | Time frame |
|---|---|
| Geometric mean titre of anti-Vi IgG antibodiesTimepoint: Baseline (pre-vaccination) and 28 days after vaccination;Seroconversion rateTimepoint: 28 days after vaccination | — |
Countries
India
Contacts
Public ContactDr Pavankumar Daultani
Cadila Healthcare Limited
Outcome results
None listed