A prospective, open-label, multicenter, phase IV clinical study to evaluate the long term persistence of immunological response after primary vaccination with Typhoid Vi Conjugate Vaccine and response to booster dose vaccination with Typhoid Vi Conjugate Vaccine of M/s Cadila Healthcare Limited in healthy subjects - None

Cadila Healthcare Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. Subjects who had participated and completed the previously conducted phase II/III clinical study (Project No. 15-03) and had received the study vaccine before 3 years Â± 3 months
•2. Informed consent from adult subjects or from parents of the pediatric subjects. Additionally, assent from pediatric subjects of >=7 years of age
•3. Adult subjects or parents of pediatric subjects literate enough to fill the diary card

•1. History of typhoid fever or vaccination against typhoid fever after previous study
•2. Subjects administered blood, blood containing products or immunoglobulins during the past 3 months
•3. Clinically significant systemic disorder such as cardiovascular, respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, hematological or immunological disorder
•4. Subjects with confirmed or suspected immunosuppressive or immunodeficiency disorder; or subjects on any immunosuppressive or immunostimulant therapy
•5. Known case of thrombocytopenia or any coagulation disorder, or subjects on anticoagulation therapy
•6. Participation in another clinical trial in the past 3 months
•7. Subjects with history of alcohol or drug abuse in the past one year

发起方