Combination vaccine is safe and effective for infants

January 9, 2009

com/archive/2009/01/08/professional/links/20090108publ001.html

Last Updated: 2009-01-08 8:00:58 -0400 (Reuters Health)

NEW YORK (Reuters Health) - 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. A. Guerra of the San

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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