A prospective, randomized, two-arm, parallel, active-controlled, multicentre, non-inferiority, phase III clinical trial to evaluate the immunogenicity and safety of ZyVac TCV of M/s Cadila Healthcare Limited compared to Typbar TCV of M/s Bharat Biotech International Limited in healthy adults aged 45 to 65 years - NA

Cadila Healthcare Limited0 个研究点目标入组 238 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. Subjects of either gender of 45 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
•4. Written informed consent from the subjects
•5. Subjects 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 typhoid fever in the past 3 years
•3. Fever of any origin or infectious disorder of 3 days or more within the past month
•4. Febrile illness (body temperature >= 37.5oC) at the time of enrollment
•5. History of any vaccination within the past month
•6. Clinically significant systemic disorder such as cardiovascular, respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, hematological or immunological disorder
•7. Confirmed or suspected immunosuppressive or immunodeficiency disorder; or
•subjects on any immunosuppressive or immunostimulant therapy
•8. Known case of thrombocytopenia or any coagulation disorder, or subjects on
•anticoagulation therapy
•9. Subjects administered blood, blood containing products or immunoglobulins within
•the last 3 months or planned administration during the study
•10. Pregnant and lactating women & female subjects not using acceptable contraceptive
•measures (double barrier methods, oral or injectable hormonal contraceptives or
•surgical sterilization)
•11. Subject participated in another clinical study in the past 3 months
•12. Subject with history of alcohol or drug abuse in the past one year
•13. Any other reason for which the investigator feels that subject should not participate

发起方