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

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.