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

Vincenzo Baldo; Paolo Bonanni; Marcela Castro; Giovanni Gabutti; Elisabetta Franco; Federico Marchetti; Rosa Prato; Francesco Vitale

doi:10.4161/hv.26269

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

Hum Vaccin Immunother. 2014;10(1):129-37. doi: 10.4161/hv.26269. Epub 2013 Sep 4.

Authors

Vincenzo Baldo¹, Paolo Bonanni², Marcela Castro³, Giovanni Gabutti⁴, Elisabetta Franco⁵, Federico Marchetti⁶, Rosa Prato⁷, Francesco Vitale⁸

Affiliations

¹ Department Molecular Medicine; Laboratory of Public Health; University of Padua; Padua, Italy.
² Department of Health Sciences; University of Florence; Florence, Italy.
³ GlaxoSmithKline Vaccines; Wavre, Belgium.
⁴ O.U. Hygiene and Public Health; Department of Prevention; Chiavarese-Liguria Region, Italy.
⁵ Department of Biomedicine and Prevention; University Tor Vergata; Rome, Italy.
⁶ GlaxoSmithKline Vaccines; Verona, Italy.
⁷ Department of Medical and Surgical Sciences; University of Foggia; Foggia, Italy.
⁸ Department of Sciences for Health Promotion and Mother to Child Care "G.D'Alessandro"; Hygiene section; University of Palermo; Palermo, 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.

Keywords: Italy; booster vaccination; combination vaccines; hexavalent vaccine; immunogenicity; primary vaccination; safety.

Publication types

Research Support, Non-U.S. Gov't
Review

MeSH terms

Clinical Trials as Topic
Diphtheria-Tetanus-Pertussis Vaccine / administration & dosage
Diphtheria-Tetanus-Pertussis Vaccine / adverse effects*
Diphtheria-Tetanus-Pertussis Vaccine / immunology*
Haemophilus Vaccines / administration & dosage
Haemophilus Vaccines / adverse effects*
Haemophilus Vaccines / immunology*
Hepatitis B Vaccines / administration & dosage
Hepatitis B Vaccines / adverse effects*
Hepatitis B Vaccines / immunology*
Humans
Italy
Poliovirus Vaccine, Inactivated / administration & dosage
Poliovirus Vaccine, Inactivated / adverse effects*
Poliovirus Vaccine, Inactivated / immunology*
Product Surveillance, Postmarketing
Vaccination / methods*
Vaccination / statistics & numerical data
Vaccines, Combined / administration & dosage
Vaccines, Combined / adverse effects
Vaccines, Combined / immunology

Substances

Diphtheria-Tetanus-Pertussis Vaccine
Haemophilus Vaccines
Hepatitis B Vaccines
Poliovirus Vaccine, Inactivated
Vaccines, Combined
diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine