Safety and Immunogenicity of a Fully Liquid Vaccine Containing Five-Component Pertussis-Diphtheria-Tetanus-Inactivated Poliomyelitis-Haemophilus influenzae Type B Conjugate Vaccines Administered at Two, Four, Six and 18 Months of Age

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dc.contributor.authorGold, Ronald
dc.contributor.authorBarreto, Luis
dc.contributor.authorFerro, Santiago
dc.contributor.authorThippawong, John
dc.contributor.authorGuasparini, Roland
dc.contributor.authorMeekison, William
dc.contributor.authorRussell, Margaret
dc.contributor.authorMills, Elaine
dc.contributor.authorHarrison, Dana
dc.contributor.authorLavigne, Pierre
dc.date.accessioned2018-09-27T12:14:36Z
dc.date.available2018-09-27T12:14:36Z
dc.date.issued2007-01-01
dc.date.updated2018-09-27T12:14:36Z
dc.description.abstractOBJECTIVE: The safety, immunogenicity and lot consistency of a fully liquid, five-component acellular pertussis combination vaccine, comprised of diphteria, tetanus and acellular pertussis, inactivated polio vaccine, Haemophilus influenzae type b (DTaP-IPV-Hib [Pediacel, sanofi pasteur, Canada]) were assessed and compared with that of Hib vaccine reconstituted with the five-component acellular pertussis combination vaccine (DTaP-IPV//Hib, Pentacel [sanofi pasteur, Canada]).METHODS: Infants were recruited at vaccine study centres in Montreal, Quebec; Simon Fraser Health Region, British Columbia, and southern Alberta after the protocol had been approved by the relevant institutional ethics committees. Written informed consent was obtained from the parents or guardians of all subjects. At two months of age, the infants were randomly assigned to receive one of three consecutive production lots of DTaP-IPV-Hib by intramuscular injection. Reactions to vaccinations were assessed by parental observation and through telephone interviews conducted by study nurses. Blood samples were obtained at two, six, seven, 18 and 19 months of age for measurement of antibodies to vaccine antigens.RESULTS: Most injection site and systemic reactions were mild or moderate, and of brief duration. All infants were protected against tetanus, diphtheria and all three polio serotypes after both primary and booster vaccinations. Antibody responses to pertussis antigens were similar to those observed in Swedish infants, in whom the five-component vaccine was shown to be 85% effective. Proportions of infants with antipolyribosylribitol phosphate antibody of 0.15 μg/mL or greater and 1.0 μg/mL or greater, were 97.9% and 88.9%, respectively, following primary immunization, and 100% and 99% following booster vaccination. Safety and immunogenicity results with both reconstituted and fully liquid combination vaccines were comparable.CONCLUSIONS: The fully liquid combination vaccine was comparable in terms of safety and immunogenicity with the reconstituted combination vaccine.
dc.description.versionPeer Reviewed
dc.identifier.citationRonald Gold, Luis Barreto, Santiago Ferro, et al., “Safety and Immunogenicity of a Fully Liquid Vaccine Containing Five-Component Pertussis-Diphtheria-Tetanus-Inactivated Poliomyelitis-Haemophilus influenzae Type B Conjugate Vaccines Administered at Two, Four, Six and 18 Months of Age,” Canadian Journal of Infectious Diseases and Medical Microbiology, vol. 18, no. 4, pp. 241-248, 2007. doi:10.1155/2007/289842
dc.identifier.doihttps://doi.org/10.1155/2007/289842
dc.identifier.urihttp://hdl.handle.net/1880/108531
dc.identifier.urihttps://doi.org/10.11575/PRISM/44043
dc.language.rfc3066en
dc.rights.holderCopyright © 2007 Hindawi Publishing Corporation. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
dc.titleSafety and Immunogenicity of a Fully Liquid Vaccine Containing Five-Component Pertussis-Diphtheria-Tetanus-Inactivated Poliomyelitis-Haemophilus influenzae Type B Conjugate Vaccines Administered at Two, Four, Six and 18 Months of Age
dc.typeJournal Article
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