None listed
Conditions
Interventions
Intervention1: Bivalent Typhoid and Paratyphoid A
Conjugate Vaccine of M/s. Zydus Lifesciences Ltd.: Dose:0.5 ml
Route:Intramuscular
Duration:- Single dose
Frequency: Once
Control Intervention1: Typho
Sponsors
Zydus Lifesciences Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1)Subjects of either gender of 6 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 or paratyphoid fever 4)Informed consent from the adult subjects or from the parents of pediatric subjects.Additionally,assent from pediatric subjects aged 7 to less than 18 years. 5)Adult subjects or parents of pediatric subject should be literate enough to fill the diary card. 6)Men and women of childbearing potential must agree to use adequate birth control measures during the study. Acceptable methods of birth control in this study include surgical sterilization,intrauterine device, oral contraceptive, contraceptive patch, long-acting injectable contraceptive, male partner s vasectomy, double-barrier method (condom or diaphragm with spermicide) or abstinence for at least 4 weeks prior to vaccine administration, during study participation and for 30 days after vaccine administration.
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 or paratyphoid fever in the past 3 years 3. Household contact with known exposure to an individual with laboratory confirmed or clinical diagnosis of typhoid or paratyphoid fever 4. Fever of any origin or infectious disorder of 3 days or more within the past month 5. Febrile illness (body temperature less than equal to 37.5 C) at the time of enrolment 6. History of any vaccination within the past month 7. Significant acute or chronic infection requiring systemic antibiotic treatment 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 16. Female participants who are pregnant, currently breastfeeding, or attempting to conceive.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Seroconversion rate of anti-Vi IgG antibodies and anti-LPS IgG antibodiesTimepoint: Day 0 to Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Geometric mean titre of anti-Vi IgG antibodies and anti-LPS IgG antibodiesTimepoint: Day 0 and Day 28;Solicited local and systemic adverse eventsTimepoint: Day 0 to Day 28;Unsolicited adverse eventsTimepoint: Day 0 to Day 28;Serious adverse eventsTimepoint: Day 0 to Day 28 | — |
Countries
India
Contacts
Public ContactDr Pavankumar Daultani
Zydus Research Centre
Outcome results
None listed