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
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Completed
- Sponsor
- Cadila Healthcare Ltd
- Enrollment
- 282
- Locations
- 6
- Primary Endpoint
- Proportion of subjects with sero-protective levels of anti-tetanus antibodies 28 days post-vaccination
Study Overview
Brief Summary
This is a randomized, single blind, parallel, active controlled, non-inferiority, multicentre clinical trial to evaluate and compare the immunogenicity and safety of Tetanus vaccine (adsorbed) of M/s Cadila Healthcare Ltd. with Tetanus vaccine (adsorbed) of M/s Serum Institute of India Ltd. in healthy subjects and subjects with clean minor wounds. Blood samples will be collected pre-vaccination (day 0) & post-vaccination (day 28) to determine anti-tetanus antibody titre. The primary objective of this study is to demonstrate the non-inferiority of test vaccine to the reference vaccine for proportion of subjects with sero-protective levels of anti-tetanus antibodies post-vaccination. The sero-protective cut-off titre for serum anti-tetanus antibodies is 0.1 IU/ml. The booster response to vaccination will be considered as per following criteria: Post-vaccination titre of ≥ 0.4 IU/ml for individuals with pre-vaccination antibody concentrations of < 0.1 IU/ml or; Four fold or greater antibody rise post-vaccination for participants with pre-vaccination antibody concentrations ≥ 0.1 IU/ml but < 2 IU/ml or; Two fold or greater antibody response post-vaccination for participants with pre-vaccination antibody levels ≥ 2 IU/ml.xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" / The safety of the vaccine will be assessed by recording the adverse events occurring during the entire course of the study.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 10.00 Year(s) to 40.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Healthy subject or subject with clean minor wound(s) of either gender between 10-40 years
- •History of previous immunization with tetanus toxoid containing vaccine
- •Written informed consent from adult subjects; or assent from adolescent subject in addition to written informed consent from subject’s legally acceptable representative
- •Adult subject or legally acceptable representative of adolescent subject literature enough to fill the diary card.
Exclusion Criteria
- •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
- •Past history of tetanus
- •Subjects with history of administration of any tetanus toxoid containing vaccine within the past 5 years
- •Subjects with thrombocytopenia or any coagulation disorder, or subjects on anticoagulation therapy
- •Subjects with confirmed or suspected immunosuppressive or immunodeficiency disorder; or subjects on any immunosuppressive or immunostimulant therapy
- •Clinically significant systemic disorder such as cardiovascular, respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, hematological or immunological disorder
- •History of any acute illness within the last 1 week
- •Subjects with febrile illness (temperature ≥ 38oC) at the time of enrollment
- •Subjects administered blood, blood containing products or immunoglobulins within the last 3 months or planned administration during the study
- •Any other parenteral vaccine administration within the last 30 days
- •Pregnant and lactating women & female subjects not using acceptable contraceptive measures (double barrier methods, oral or injectable hormonal contraceptives or surgical sterilization)
- •Participation in another clinical trial in the past 3 months
- •Subjects with history of alcohol or drug abuse in the past one year.
Outcomes
Primary Outcomes
Proportion of subjects with sero-protective levels of anti-tetanus antibodies 28 days post-vaccination
Time Frame: 28 days following vaccination
Secondary Outcomes
- Proportion of subjects with booster response to tetanus toxoid 28 days post-vaccination(28 days following vaccination)
- Geometric mean titre of anti-tetanus antibodies at baseline and 28 days post-vaccination(28 days following vaccination)