CTRI/2022/02/040274CompletedPhase 4
A prospective, randomized, parallel, three-arm, open-label, multicenter, phase IV clinical trial to evaluate the immunological non-interference of Typhoid Vi conjugate vaccine with Measles and Rubella vaccine administered to healthy infants
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Cadila Healthcare Limited
- Enrollment
- 900
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •1. Healthy infant subject of either gender aged (Age calculated as per completed months) 9 to 10 months at the time of enrollment
- •2. Subjects should be in good health as determined by medical history and physical examination based on clinical judgment of the investigator
- •3. No history of vaccination against typhoid fever, measles and rubella
- •4. Written informed consent from the subjectâ??s parent (mother/father)
- •5. Subjectâ??s parent literate enough to fill the diary card
Exclusion Criteria
- •1. History of hypersensitivity reaction to any component of the vaccines
- •2. History of laboratory confirmed or suspected measles, rubella or typhoid fever in past
- •3. History of any vaccination against typhoid fever, measles or rubella in past
- •4. Subject exposed (Close contact (family member or neighbour) with laboratory confirmed or clinical diagnosis
- •of measles / rubella / typhoid fever) to measles virus, rubella virus or Salmonella typhi within the past 30 days
- •5. Fever of any origin or infectious disorder of 3 days or more within the past 30 days
- •6. Febrile illness (axillary temperature >= 37.5°C) at the time of enrollment
- •7. History of any vaccination within the past 30 days
- •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. Subject participated in another clinical study in the past 3 months
- •13. Any other reason for which the investigator feels that subject should not participate
Investigators
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