Seventeen years of post-licensure experience confirms confidence in the safety profile of DTPa-HBV-IPV/Hib in routine use, with a favorable benefit-risk profile in infants and toddlers. Reporting of preparation errors (mostly reconstitution) was low and did not impact the vaccine’s benefit-risk profile. The most common vaccination errors were mistakes in the vaccination schedule. The analyses confirmed that increases in spontaneous reporting proportions of convulsions with/without fever and hypotonic-hyporesponsive episodes after co-administration of DTPa-HBV-IPV/Hib and 13-valent pneumococcal conjugate vaccine remained small and their clinical significance unknown. An observed-to-expected analysis did not show an increased risk of sudden death after DTPa-HBV-IPV/Hib vaccination, in line with previous observations. A review of extensive limb swelling did not reveal any safety concerns. The most common spontaneously reported adverse events (AEs) after DTPa-HBV-IPV/Hib vaccination in children were fever (reporting rate: 7.74/100,000 doses distributed), crying (2.62/100,000), injection site erythema (1.87/100,000) and swelling (1.28/100,000). Global post-licensure passive surveillance data collected in GSK’s central safety database since DTPa-HBV-IPV/Hib’s launch (2000) are described. This paper reports 17 years of passive safety surveillance of routine use of the pediatric hexavalent diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus-Haemophilus influenzae type b-conjugate vaccine (DTPa-HBV-IPV/Hib, Infanrix hexa, GSK). Additional issues surrounding the use of hexavalent vaccines are also reviewed.

These data show DTPa-HBV-IPV/Hib to be highly immunogenic and well tolerated across a range of different primary and booster vaccination schedules, as well as when administered concomitantly with other licensed vaccines (e.g., pneumococcal conjugate vaccine). Over 8 years since its first licensure, this review looks at the immunogenicity, efficacy and safety profile of the only hexavalent pediatric vaccine currently in use-Infanrix hexa (diphtheria, tetanus, acellular pertusis-hepatitis B virus-inactivated poliovirus vaccine/Haemophilus influenzae type b vaccine GlaxoSmithKline Biologicals, Rixensart, Belgium)-through published clinical trials and postmarketing surveillance data. Hexavalent vaccines, including diphtheria, tetanus, pertussis, hepatitis B, polio and Haemophilus influenzae type b antigens represent the latest advance in the development of combination vaccines.

Owing to improvements in quality and convenient modes of administration, they have become part of routine pediatric practice. Combination vaccines that include multiple antigens within one formulation are now widely accepted as an effective means of eliciting protection against several diseases at the same time.

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