Clinical study to evaluate and compare the immunogenicity and safety of Tetanus vaccine of Cadila Healthcare Ltd. vs Tetanus vaccine of Serum Institute of India Ltd. in healthy subjects and subjects with clean minor wounds
- Conditions
- Health Condition 1: Z23- Encounter for immunization
- Registration Number
- CTRI/2015/05/005740
- Lead Sponsor
- Cadila Healthcare Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 283
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of subjects with sero-protective levels of anti-tetanus antibodies 28 days post-vaccinationTimepoint: 28 days following vaccination
- Secondary Outcome Measures
Name Time Method Geometric mean titre of anti-tetanus antibodies at baseline and 28 days post-vaccinationTimepoint: 28 days following vaccination;Proportion of subjects with booster response to tetanus toxoid 28 days post-vaccinationTimepoint: 28 days following vaccination