Health Condition 1: R62- Lack of expected normal physiological development in childhood and adults
Conditions
Interventions
Intervention1: ZyVac TCV: Day 0 - Participants of both study groups will receive a 0.5 mL single dose of Typhoid Vi Conjugate Vaccine I.P. of M/s. Zydus Lifesciences Ltd. as an intramuscular injectio
Sponsors
Zydus Lifesciences Limited
Cliantha Research Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female aged 6 months (completed months) to less than 5 years (5 years old child cannot be enrolled). 2. Healthy or with moderate to severe malnutrition as per WHO growth standards (Refer Appendix I) 3. No previous history of vaccination (oral or injectable) against typhoid fever 4. Parents literate enough to fill the participant diary 5. Participants and their parents likely to be available for follow-up for entire duration of the study 6. Availability of informed consent from the parents of participants
Exclusion criteria
Exclusion criteria: 1. History of hypersensitivity reaction or serious adverse event to any component of the vaccine 2. History of laboratory confirmed or suspected typhoid fever in the past 3 years 3. Fever of any origin or infectious disorder of 3 days or more within the past month 4. Febrile illness (body temperature greater than or equals to 37.5 C) at the time of enrollment 5. History of any vaccination within the past 4 weeks 6. Clinically significant systemic disorder, such as cardiovascular, respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, hematological, immunological, or major congenital 7. Confirmed or suspected immunosuppressive or immunodeficiency disorder or on any immune-suppressive or immunostimulant therapy 8. Known case of thrombocytopenia or any coagulation disorder, or on anticoagulation therapy 9. Administered with blood, blood containing products, or immunoglobulins within the last 3 months or planned administration during the duration of the study 10. Participation in any clinical trial in the last 3 months 11. Any other reason, in the opinion of the investigator, due to which participation is not recommended
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Seroconversion rate at 28 days after vaccinationTimepoint: 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Seroconversion: Seroconversion rate at 180 days after vaccination 2. Geometric mean titer: bodies at the baseline and at 28 and 180 days after vaccination 3. Solicited local and systemic AEs reported during the study 4. Unsolicited AEs reported during the study 5. Medically attended AEs reported during the study 6. Serious AEs reported during the study Timepoint: 1. 26 Weeks 2. At 4 weeks and 26 Weeks 3. During the Study 4. During the Study 5. During the Study 6. During the Study | — |
Countries
India
Contacts
Public ContactMr Devesh Verma
Cliantha Research Limited
Outcome results
None listed