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

• Published in: Jornal de pediatria 2007-11, Vol.83 (6), p.523-528
• Main Authors: Martins, Reinaldo M, Camacho, Luiz A B, Lemos, Maria Cristina F, Noronha, Tatiana G de, Carvalho, Maria Helena C de, Greffe, Nadja, da Silva, Marli M, Périssé, André R, Maia, Maria Lourdes S, Homma, Akira
• Format: Article
• Language: English
• Subjects: 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
• ISSN: 0021-7557
• DOI: 10.2223/JPED.1721

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. 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. 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. 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.