0P-S2-5

A NEW FULLY LIQUID DTAP-IPV-HIB-HB HEXAVALENT COMBINATION VACCINE

Luc Hessel M.D.

Aventis Pasteur MSD, Lyon, France

 

To reduce the number of injections needed to comply with pediatric vaccination requirements, a liquid, hexavalent vaccine (DTacP-IPV-PRP-T-HBs; Hexavac; Aventis Pasteur MSD) has been developed for primary and booster vaccination of infants. In extensive clinical studies, Hexavac has been shown to be highly immunogenic. Seroconversion or seroprotective titers of antibodies against all antigens were achieved in the majority of infants following a primary series of three doses administered at 1-2 month intervals from 2 months of age. Hexavac also induced immunologic memory, as evidenced by the strong anamnestic response to booster vaccination at 12-18 months of age. These responses were comparable with those seen following concomitant administration of Pentavac and H-B-Vax II, and were also within the ranges observed for other relevant licensed vaccines. Clinical studies comparing the immunogenicity of Hexavac administered at either 2, 3 and 4 or 2, 4 and 6 months demonstrated that it can be used by either vaccination schedule. A further study also supported the use of primary doses of Hexavac at 3 and 5 months with a booster at 12 months of age. Hexavac has a good reactogenicity and tolerability profile. The most frequently reported adverse events after both primary and booster doses were local reactions of redness and swelling/induration and a systemic response of mild fever, irrespective of the vaccine used for priming. Hexavac therefore represents an ideal opportunity to provide protection against six important childhood diseases with a single injection at each clinic visit.