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

Cadila Healthcare Limited0 个研究点目标入组 900 人开始时间: 待定最近更新: 2023年5月1日

试验速览

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•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

•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 >= 37.5Â°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

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