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The immunogenicity and reactogenicity of DTPw-HBV/Hib 2.5 combination vaccine: results from four phase III multicenter trials across three continents.

Author(s): Ortega-Barria E, Kanra G, Leroux G, Bravo L, Safary A, Lefevre I, DTPw-HBV/Hib 2.5 study group

Affiliation(s): GlaxoSmithKline Biologicals, Rue de l'institut 89, Rixensart, Belgium.

Publication date & source: 2007-12-05, Vaccine., 25(50):8432-40. Epub 2007 Oct 9.

Publication type: Clinical Trial, Phase III; Comparative Study; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

This paper presents the results of four separate phase III trials, which assessed the immunogenicity and reactogenicity of DTPw-HBV/Hib 2.5 in comparison with licensed Tritanrix-Hep B (GlaxoSmithKline Biologicals) and Hiberix (10 microg PRP), given as separate or mixed injections (3 trials) or with or without hepatitis B vaccine at birth (1 trial). The immunogenicity of DTPw-HBV/Hib 2.5 was non-inferior to the reference vaccine regimen in terms of seropositivity rates. The overall reactogenicity profile of DTPw-HBV/Hib 2.5 was also similar to that of the reference vaccine regimen. These results confirm the previously established immunogenicity and safety of reduced dose PRP conjugated vaccine regimens.

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