None listed
Conditions
Interventions
Intervention1: Typhoid Vi Conjugate Vaccine I.P. of M/s.
Zydus Lifesciences Limited & Yellow Fever Vaccine (WHO prequalified): TCV: The vaccine will be available in the liquid form. A 0.5 ml single do
Sponsors
Zydus Lifesciences Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects of either gender of 9 months to 65 years of age (both inclusive) 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 or yellow fever 4. Informed consent from the adult subjects or from the parents of pediatric subjects. Additionally, assent from pediatric subjects aged 7 to 5. Adult subjects or parents of pediatric subjects literate enough to fill the diary card
Exclusion criteria
Exclusion criteria: 1. History of hypersensitivity reaction to any component of the study vaccines including egg and chicken proteins 2. History of laboratory confirmed or suspected typhoid fever in the past 3 years 3. History of laboratory confirmed or suspected yellow fever in the past 4. Fever of any origin or infectious disorder of 3 days or more within the past month 5. Febrile illness (body temperature >=37.5°C) at the time of enrollment 6. Subjects positive for serological markers against Dengue infection(NS1 antigen, IgM and IgG antibodies) 7. History of any vaccination within the past month 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 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 |
|---|---|
| Non-inferiority for seroconversion for anti-Vi and anti-YF IgG antibodies at 28 days after vaccinationTimepoint: At 28 days after respective vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity-Geometric mean titre of anti-Vi and anti-YF IgG antibodies at 28 days after vaccinationTimepoint: At 28 days after respective vaccination;Safety- Solicited local and systemic adverse events & Unsolicited adverse events reported during the studyTimepoint: Throughout the study duration;Safety-Serious adverse events reported during the studyTimepoint: Throughout the study duration | — |
Countries
India
Contacts
Public ContactDr Pavan Daultani
Zydus Lifesciences Limited
Outcome results
None listed