A Study to Evaluate the Adverse Reaction of Tetanus Vaccine (Adsorbed) in Healthy Indian Adults

Abstract

BACKGROUND Tetanus disease is one of the most dramatic and globally prevalent diseases of humans and vertebrate animals and has been reported for over 24 centuries. The manifestation of the disease, spastic paralysis, is caused by the second most poisonous substance known as the tetanus toxin. According to the World Health Organisation, India had reported 70,335 cases of Tetanus in the period from 2000 -2015, of these 17,025 cases were neonatal tetanus. Serological surveys have demonstrated an increasing proportion of patients with inadequate immunity as age increases: 49% -66% of patients over 60 years had antibody levels below the protective level. [4][5][6] MATERIALS AND METHODSThis was a single arm, uncontrolled clinical trial study to evaluate the adverse events following Tetanus Vaccine (Adsorbed) in healthy adult subjects. Total 39 healthy individuals consented for the study and after exclusion criteria all eligible were e nrolled into the study, i.e. a total of 34 healthy adult subjects aged 18 to 45 years were enrolled into the study. All selected individuals were admitted as IP for evaluation of the adverse reactions for 3 days and follow-up till 28 days. Single dose of the Tetanus Vaccine (Adsorbed) 0.5 mL was administered as deep intramuscular injection into the deltoid region. Observation period was 28 days after vaccination. There were no antibody estimation done in this trial. Local and systemic reactions were collected for 28 days following injection using Diary Card (i.e. Day 0 to Day 28). All AEs, SAEs and AEs that lead to withdrawal from the study and related prescription vaccines were collected for the entire study period. RESULTSThe study population consisted of 34 healthy adult subjects aged between 18 and 45 years. All subjects received the study vaccine and hence the safety population consisted of all (100%) vaccinated subjects. CONCLUSIONThis was a single arm study designed to evaluate the safety and tolerability of Tetanus Vaccine (Adsorbed) in healthy adult subjects. A total of 34 healthy adult subjects aged 21 to 44 years were enrolled into the study. A total of 39 subjects were screened for the study. Of these, 34 subjects received the study vaccine.