NEW YORK (Reuters Health) Jan 08 - A combination vaccine against diphtheria, tetanus, pertussis, polio and flu, which is routinely used in Canadian children, has been shown to be immunogenic and well tolerated in a U.S. study.
The randomized trial was conducted to support U.S. licensure of the vaccine -- DTaP5-IPV-Hib -- which incorporates diphtheria-tetanus-5-component acellular pertussis (DTaP5), inactivated poliovirus (IPV), and Haemophilus influenzae type B (Hib) vaccines.
Nearly 2000 infants were vaccinated at 2, 4, and 6 months of age, either with the DTaP5-IPV-Hib combination vaccine (Pentacel; Sanofi Pasteur Ltd., Toronto, Ontario) or with the DTaP5, IPV and Hib vaccines administered separately. Some babies in each group were also given fourth dose of DTaP5-IPV-Hib or of the DTaP5 and Hib vaccines as toddlers.
In the January issue of Pediatrics, Dr. Fernando A. Guerra of the San Antonio Metropolitan Health District in Texas and colleagues report that, compared with licensed vaccines, the combined vaccine produced similar or fewer injection site and systemic reactions with "noninferior" seroresponse and seroprotection rates, along with identical or higher concentrations of antibodies to pertussis toxoid, filamentous hemagglutinin, and Hib polysaccharide.
The children were followed up to age 5, at which time "the two groups had comparable persistence of antibodies...to all vaccine antigens in the DTaP5-IPV-Hib vaccine, except for pertactin," according to the article.
"The current results are reassuring and consistent with safety surveillance data in Canada, where for the past decade, the combination vaccine has been the only DTaP-containing vaccine used among infants and toddlers," the researchers conclude.
Pediatrics 2009;123:301-312.
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