title: Incidence of hypotonic-hyporesponsive episodes associated to the combined DTP/Hib vaccine used in Brazilian National Immunizations Program.
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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors: Fundação Oswaldo Cruz (Fiocruz), Rio de Janeiro, RJ, Brazil.
authors: Reinaldo M
authors: RM
authors: Martins
authors: Luiz A B
authors: LA
authors: Camacho
authors: Maria Cristina F
authors: MC
authors: Lemos
authors: Tatiana G de
authors: TG
authors: Noronha
authors: Maria Helena C de
authors: MH
authors: Carvalho
authors: Nadja
authors: N
authors: Greffe
authors: Marli M
authors: MM
authors: da Silva
authors: André R
authors: AR
authors: Périssé
authors: Maria Lourdes S
authors: ML
authors: Maia
authors: Akira
authors: A
authors: Homma
mesh_terms: D001938:Brazil / Q000453:epidemiology; D015331:Cohort Studies; D004165:Diphtheria / Q000517:prevention & control; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000008:administration & dosage / Q000009:adverse effects*; D005260:Female; D005334:Fever / Q000453:epidemiology / Q000209:etiology*; D006192:Haemophilus Infections / Q000517:prevention & control; D018073:Haemophilus Vaccines / Q000008:administration & dosage / Q000009:adverse effects*; D006801:Humans; D017589:Immunization Programs / Q000706:statistics & numerical data*; D015994:Incidence; D007223:Infant; D007407:Interviews as Topic; D008297:Male; D012640:Seizures / Q000453:epidemiology / Q000209:etiology*; D012720:Severity of Illness Index; D013742:Tetanus / Q000517:prevention & control; D014917:Whooping Cough / Q000517:prevention & control
chemical_list: D015721:Diphtheria-Tetanus-Pertussis Vaccine; D018073:Haemophilus Vaccines; C080881:diphtheria-tetanus-pertussis-haemophilus b conjugate vaccine