CTRI/2024/01/061080Active, not recruitingPhase 4
A prospective, randomized, parallel, three-arm,open-label, multicenter, phase IV clinical trial toevaluate the immunological non-interference ofTyphoid Vi conjugate vaccine with Yellow fevervaccine administered to healthy subjects - Indian
Trial Snapshot
- Phase
- Phase 4
- Status
- Active, not recruiting
- Sponsor
- Zydus Lifesciences Limited
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility 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 <18 years
- •5. Adult subjects or parents of pediatric subjects literate enough to fill the diary card
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
Investigators
Similar Trials
Completed
Phase 4
A clinical study to evaluate non-interference of immune response generated by Typhoid conjugate vaccine and Measles and Rubella vaccine administered to healthy infantsCTRI/2022/02/040274Cadila Healthcare Limited900
Completed
Not Applicable
A clinical study to evaluate the Efficacy and Safety of Garlixir TM capsules (250 mg or 500 mg) in Hyperlipidemia patientsCTRI/2016/09/007273Biogen Extracts Pvt Ltd78
Active, not recruiting
Phase 1
Parallel group, blinded, multi-centre study of mifepristone in patients with endometriosisendometriosis in reproductive-ageMedDRA version: 20.0 Level: PT Classification code 10014778 Term: Endometriosis System Organ Class: 10038604 - Reproductive system and breast disordersEUCTR2018-002367-26-HUitaphar Laboratorios490
Active, not recruiting
Phase 1
Parallel group, blinded, multi-centre study of mifepristone in patients with endometriosisendometriosis in reproductive-ageMedDRA version: 20.0Level: PTClassification code 10014778Term: EndometriosisSystem Organ Class: 10038604 - Reproductive system and breast disordersEUCTR2018-002367-26-BGitaphar Laboratorios220
Active, not recruiting
Phase 1
Parallel group, blinded, multi-centre study of mifepristone in patients with endometriosisEUCTR2018-002367-26-PLitaphar Laboratorios490