Incidence of hypotonic-hyporesponsive episodes associated to the combined DTP/Hib vaccine used in Brazilian National Immunizations Program

J Pediatr (Rio J). 2007 Nov-Dec;83(6):523-8. doi: 10.2223/JPED.1721.

Abstract

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.

MeSH terms

  • Brazil / epidemiology
  • Cohort Studies
  • Diphtheria / prevention & control
  • Diphtheria-Tetanus-Pertussis Vaccine / administration & dosage
  • Diphtheria-Tetanus-Pertussis Vaccine / adverse effects*
  • Female
  • Fever / epidemiology
  • Fever / etiology*
  • Haemophilus Infections / prevention & control
  • Haemophilus Vaccines / administration & dosage
  • Haemophilus Vaccines / adverse effects*
  • Humans
  • Immunization Programs / statistics & numerical data*
  • Incidence
  • Infant
  • Interviews as Topic
  • Male
  • Seizures / epidemiology
  • Seizures / etiology*
  • Severity of Illness Index
  • Tetanus / prevention & control
  • Whooping Cough / prevention & control

Substances

  • Diphtheria-Tetanus-Pertussis Vaccine
  • Haemophilus Vaccines
  • diphtheria-tetanus-pertussis-haemophilus b conjugate vaccine