A clinical trial to evaluate the immunological non-interference of typhoid Vi conjugate vaccine with yellow fever vaccine administered to healthy subjects
- Registration Number
- CTRI/2024/01/061080
- Lead Sponsor
- Zydus Lifesciences Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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 <18 years
5. Adult subjects or parents of pediatric subjects literate enough to fill the diary card
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
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method on-inferiority for seroconversion for anti-Vi and anti-YF IgG antibodies at 28 days after vaccinationTimepoint: At 28 days after respective vaccination
- Secondary Outcome Measures
Name Time Method 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