Combined hexavalent diphtheria-tetanus-acellular pertussis-hepatitisB-inactivated poliovirus-Haemophilus influenzae type B vaccine; Infanrix™ hexa:twelve years of experience in Italy.

Infant vaccination using 2-dose priming at 3 and 5 mo of age with a booster at11-12 mo of age was pioneered in Italy. The 3-5-11 schedule is now used in agrowing number of European countries. Infanrix™ hexa (DTPa-HBV-IPV/Hib,GlaxoSmithKline Vaccines) was first licensed for use in 2000 and has been theonly pediatric hexavalent vaccine available since 2005. We reviewed availableclinical trial data describing the immunogenicity of DTPa-HBV-IPV/Hib whenadministered at 3, 5, and 11 mo of age, and conducted an analysis of safety usingglobal and Italian post-marketing surveillance data. In Italy, DTPa-HBV-IPV/Hibhas a demonstrated safety record extending over a decade of use, it has beenassociated with record levels of vaccine coverage, and with sustained diseasecontrol in vaccinated cohorts. Hexavalent vaccines will continue to contribute tohigh vaccine coverage in Italy and across Europe.