A prospective, randomized, two arm, single blind, parallel, active controlled, multicentre, non-inferiority, phase II/III clinical study to evaluate the immunogenicity and safety of Tetanus vaccine (adsorbed) of M/s Cadila Healthcare Limited compared to Tetanus vaccine (adsorbed) of M/s Serum Institute of India Limited in healthy subjects and subjects with clean minor wounds

Cadila Healthcare Ltd0 个研究点目标入组 283 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. Healthy subject or subject with clean minor wound(s) of either gender between 10-40 years
•2. History of previous immunization with tetanus toxoid containing vaccine
•3. Written informed consent from adult subjects; or assent from adolescent subject in addition to written informed consent from subjectâ??s legally acceptable representative
•4. Adult subject or legally acceptable representative of adolescent subject literature enough to fill the diary card

•1. Past history of hypersensitivity reaction, neurological disorder or any serious adverse event to any component of tetanus toxoid containing vaccine including thiomersal (a mercury derivative) and 2-Phenoxyethanol
•2. Past history of tetanus
•3. Subjects with history of administration of any tetanus toxoid containing vaccine within the past 5 years
•4. Subjects with thrombocytopenia or any coagulation disorder, or subjects on anticoagulation therapy
•5. Subjects with confirmed or suspected immunosuppressive or immunodeficiency disorder; or subjects on any immunosuppressive or immunostimulant therapy
•6. Clinically significant systemic disorder such as cardiovascular, respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, hematological or immunological disorder
•7. History of any acute illness within the last 1 week
•8. Subjects with febrile illness (temperature >= 38oC) at the time of enrollment
•9. Subjects administered blood, blood containing products or immunoglobulins within the last 3 months or planned administration during the study
•10. Any other parenteral vaccine administration within the last 30 days
•11. Pregnant and lactating women & female subjects not using acceptable contraceptive measures (double barrier methods, oral or injectable hormonal contraceptives or surgical sterilization)
•12. Participation in another clinical trial in the past 3 months
•13. Subjects with history of alcohol or drug abuse in the past one year

发起方