The use of toxoid for the prevention of tetanus neonatorum. Final report of a double-blind controlled field trial

Abstract

With a view to determining the effectiveness of a method for the control of tetanus neonatorum which would be independent of medical examination or care, a double-blind field trial covering 1618 women was conducted between 1961 and 1966 in a rural area of Colombia with an estimated existing tetanus neonatorum death rate of 11.6 per 100 births. The study group was given 1-3 injections of 1 ml of an aluminium-phosphate-adsorbed tetanus toxoid more than 6 weeks apart, and the control group a similar number of injections of an influenza-virus vaccine.There was no statistically significant difference between those in the two groups given one injection. Those in the control group given 2 or 3 injections had a tetanus neonatorum death rate of 7.8 deaths per 100 births, and the corresponding subjects in the study group had none. This difference is unlikely to have occurred by chance.