Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
7-8
pubmed:dateCreated
2001-2-2
pubmed:abstractText
Three hundred and twenty eligible infants were enrolled in an open randomized clinical trial and allocated to one of two groups to receive either separate concomitant injections of a candidate combined DTPa-HBV-IPV and commercial 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). Vaccines were administered at 6, 10 and 14 weeks of age preceded by a monovalent dose of HBV at birth. The candidate vaccine administration was shown to be at least as immunogenic (primary objective) as the candidate administration with respect to the diphtheria, tetanus, polio, HBs and PRP seroprotection rates (primary endpoints). Post vaccination, both vaccine administrations showed an equivalent level of seroprotection with nearly all subjects (>96%) acquiring seroprotective titers against diphtheria, tetanus, polioviruses, 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 subjects 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 compared 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 tolerability over the commercial vaccines DTPw-IPV/Hib and HBV.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Nov
pubmed:issn
0264-410X
pubmed:author
pubmed:issnType
Print
pubmed:day
22
pubmed:volume
19
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
825-33
pubmed:dateRevised
2006-11-15
pubmed:meshHeading
pubmed:year
2000
pubmed:articleTitle
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.
pubmed:affiliation
Medical University, Bd Stefan cel Mare 165, 2004, Chisinau, Moldova.
pubmed:publicationType
Journal Article, Clinical Trial, Comparative Study, Randomized Controlled Trial