A phase III, randomized controlled study to assess the safety and immunogenicity of a semi-synthetic diphtheria, tetanus and whole-cell pertussis vaccine in Indian infants

► Reactions to DPT vaccine are well known. ► WHO suggests semi-synthetic medium for manufacture of diphtheria and tetanus toxoids. ► SIIL manufactured semi-synthetic diphtheria and tetanus toxoid. ► This vaccine had a significantly lower incidence of reactions. ► Both vaccines provided adequate seroprotection in the target population.