6533b826fe1ef96bd1283df9

RESEARCH PRODUCT

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

Vitale FrancescoRosa PratoElisabetta FrancoMarcela CastroFederico MarchettiGiovanni GabuttiVincenzo BaldoPaolo Bonanni

subject

safetybooster vaccination; combination vaccines; hexavalent vaccine; immunogenicity; Italy; primary vaccination; safety; Clinical Trials as Topic; Diphtheria-Tetanus-Pertussis Vaccine; Haemophilus Vaccines; Hepatitis B Vaccines; Humans; Italy; Poliovirus Vaccine Inactivated; Product Surveillance Postmarketing; Vaccination; Vaccines Combined; Medicine (all)Settore MED/42 - Igiene Generale e ApplicataImmunologySocio-culturaleReviewimmunogenicitySettore MED/42 - Igiene Generale E Applicatamedicine.disease_causeprimary vaccinationProduct Surveillance PostmarketingmedicineImmunology and AllergyHumansHepatitis B VaccinesVaccines CombinedDiphtheria-Tetanus-Pertussis VaccineHaemophilus VaccinesPharmacologycombination vaccinesbooster vaccination; combination vaccines; hexavalent vaccine; immunogenicity; Italy; primary vaccination; safety; Medicine (all)Clinical Trials as TopicVaccinescombination vaccineTetanusbusiness.industryCombinedImmunogenicityPoliovirusDiphtheriaMedicine (all)VaccinationInactivatedHepatitis Bmedicine.diseaseVirologyProduct SurveillancePostmarketingClinical trialVaccinationPoliovirus Vaccinebooster vaccinationPoliovirus Vaccine InactivatedInfanrix hexaItalyhexavalent vaccine; primary vaccination; booster vaccination; Italy; combination vaccines; immunogenicity; safetybusinesshexavalent vaccine

description

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.

yearjournalcountryeditionlanguage
2014-01-01
10.4161/hv.26269http://hdl.handle.net/2108/140283