摘要
objective:to evaluate the safety of a combined diphtheria-tetanus-whole cell pertussis-haemophilus influenzae type b vaccine used on the brazilian national immunizations program, chiefly the incidence of hypotonic-hyporesponsive episodes. method: follow-up of a cohort of 21,064 infants (20,925 or 99.7% adhered to the study protocol), within 48 hours of vaccination with diphtheria-tetanus-whole cell pertussis-haemophilus influenzae type b vaccine in health care units in the city of rio de janeiro, to ascertain and investigate spontaneous and solicited severe adverse events. each child was followed-up for one dose only. results: the rate of hypotonic-hyporesponsive episodes was 1/1,744 doses (confirmed cases) and 1/1,495 doses (confirmed plus suspect cases). the rate of convulsions was 1/5,231 doses. no cases of apnea were detected. these results are comparable to those found in the literature with diphtheria-tetanus-whole cell pertussis vaccine. conclusion: the diphtheria-tetanus-whole cell pertussis-haemophilus influenzae type b vaccine under study can be safely used in the national immunizations program, according to the current precautions and contraindications.