A new DTPa-HBV-IPV vaccine co-administered with Hib, compared to a commercially available DTPw-IPV/Hib vaccine co-administered with HBV, given at 6, 10 and 14 weeks following HBV at birth

Three hundred and twenty eligible infants were enrolled in an open randomiz ed clinical trial and allocated to one of two groups to receive either sepa rate concomitant injections of a candidate combined DTPa-HBV-IPV and commer cial Hib vaccine (candidate administration: DTPa-HBV-IPV + Hib) or separate concomitant injections of licensed DTPw-IPV mixed in the same syringe with Hib and HBV vaccines (comparator administration: DTPw-IPV/Hib + HBV). Vacc ines were administered at 6, 10 and 14 weeks of age preceded by a monovalen t dose of HBV at birth. The candidate vaccine administration was shown to b e at least as immunogenic (primary objective) as the candidate administrati on with respect to the diphtheria, tetanus, polio, HBs and PRP seroprotecti on rates (primary endpoints). Post vaccination, both vaccine administration s showed an equivalent level of seroprotection with nearly all subjects (> 96%) acquiring seroprotective titers against diphtheria, tetanus: polioviru ses, HBsAg and PRP antigens. A markedly higher anti-HBs response post dose 2 at week 14 in the group receiving the candidate vaccine, 98.6% of subject s had seroprotective titers (GMT of 505.7 mIU/ml) compared with only 88.7% (GMT of 107.5 mIU/ml) in the comparator group. There was a lower incidence of adverse events following the DTPa-based candidate administration compare d with the DTPw-based comparator. Despite the early age and short interval between doses, both administrations were immunogenic, with the concomitant administration of DTPa-HBV-IPV and Hib vaccines showing an improved tolerab ility over the commercial vaccines DTPw-IPV/Hib and HBV. (C) 2000 Elsevier Science Ltd. All rights reserved.