Interchangeability of two diphtheria and tetanus toxoids, acellular pertussis, inactivated poliovirus, Haemophilus influenzae type b conjugate vaccines as a fourth dose in 15-20-month-old toddlers
Abstract
Since 1998, all children in Canada have been immunized with a pentavalent diphtheria and tetanus toxoids, acellular pertussis, inactivated poliovirus, Haemophilus influenzae type b conjugate vaccine (DTaP-IPV-Hib) produced by one manufacturer (Pentacel). Recently, another DTaP-IPV-Hib (Infanrix-IPV-Hib) became available. Data on the interchangeability of these products was lacking. In this multicentered, observer-blind study, healthy 15-20-month-old children previously immunized with three doses of Pentacel were randomly allocated to receive a single dose of Pentacel or Infanrix-IPV-Hib. Adverse events were documented by diary for 7 days post-immunization and unsolicited adverse events were documented for 30 days. 433 participants were enrolled (mean age 17.1 months). Rates of fever, anorexia and irritability were similar in both groups. Injection-site redness >20 mm (11.5% versus 5.6%; p = 0.038), injection-site pain (52.1% versus 39.4%; p = 0.009) and moderate or greater drowsiness (13.8% versus 7.4%; p = 0.042) were more common after Pentacel than Infanrix-IPV-Hib. The proportions of participants who were sero-protected or who sero-responded were similar for all antigens. Geometric mean titers or concentrations were similar ...Continue Reading
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