CTRI/2015/05/005740
Completed
Phase 2
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
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Cadila Healthcare Ltd
- Enrollment
- 283
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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