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

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

Author information

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

PMID:
24004825
PMCID:
PMC4181021
DOI:
10.4161/hv.26269
[Indexed for MEDLINE]
Free PMC Article

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