title: Combined hexavalent diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus-Haemophilus influenzae type B vaccine; Infanrix™ hexa: twelve years of experience in Italy.
abstract: Infant vaccination using 2-dose priming at 3 and 5 mo of age with a booster at 11-12 mo of age was pioneered in Italy. The 3-5-11 schedule is now used in a growing number of European countries. Infanrix™ hexa (DTPa-HBV-IPV/Hib, GlaxoSmithKline Vaccines) was first licensed for use in 2000 and has been the only pediatric hexavalent vaccine available since 2005. We reviewed available clinical trial data describing the immunogenicity of DTPa-HBV-IPV/Hib when administered at 3, 5, and 11 mo of age, and conducted an analysis of safety using global and Italian post-marketing surveillance data. In Italy, DTPa-HBV-IPV/Hib has a demonstrated safety record extending over a decade of use, it has been associated with record levels of vaccine coverage, and with sustained disease control in vaccinated cohorts. Hexavalent vaccines will continue to contribute to high vaccine coverage in Italy and across Europe.
authors.affiliation: Department Molecular Medicine; Laboratory of Public Health; University of Padua; Padua, Italy.
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Baldo
authors.affiliation: Department of Health Sciences; University of Florence; Florence, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Bonanni
authors.affiliation: GlaxoSmithKline Vaccines; Wavre, Belgium.
authors.forename: Marcela
authors.initials: M
authors.lastname: Castro
authors.affiliation: O.U. Hygiene and Public Health; Department of Prevention; Chiavarese-Liguria Region, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Gabutti
authors.affiliation: Department of Biomedicine and Prevention; University Tor Vergata; Rome, Italy.
authors.forename: Elisabetta
authors.initials: E
authors.lastname: Franco
authors.affiliation: GlaxoSmithKline Vaccines; Verona, Italy.
authors.forename: Federico
authors.initials: F
authors.lastname: Marchetti
authors.affiliation: Department of Medical and Surgical Sciences; University of Foggia; Foggia, Italy.
authors.forename: Rosa
authors.initials: R
authors.lastname: Prato
authors.affiliation: Department of Sciences for Health Promotion and Mother to Child Care "G.D'Alessandro"; Hygiene section; University of Palermo; Palermo, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Vitale
mesh_terms: D002986:Clinical Trials as Topic; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D018073:Haemophilus Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D017325:Hepatitis B Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D006801:Humans; D007558:Italy; D011054:Poliovirus Vaccine, Inactivated / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D011358:Product Surveillance, Postmarketing; D014611:Vaccination / Q000379:methods* / Q000706:statistics & numerical data; D017778:Vaccines, Combined / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
chemical_list: D015721:Diphtheria-Tetanus-Pertussis Vaccine; D018073:Haemophilus Vaccines; D017325:Hepatitis B Vaccines; D011054:Poliovirus Vaccine, Inactivated; D017778:Vaccines, Combined; C541235:diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine
keywords: Italy; booster vaccination; combination vaccines; hexavalent vaccine; immunogenicity; primary vaccination; safety