Review of 8 years of experience with Infanrix hexa™ (DTPa–HBV–IPV/Hib hexavalent vaccine)

Abstract

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. Owing to improvements in quality and convenient modes of administration, they have become part of routine pediatric practice. 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. 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 [DTPa–HBV–IPV/Hib]; GlaxoSmithKline Biologicals, Rixensart, Belgium) – through published clinical trials and postmarketing surveillance data. 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). Additional issues surrounding the use of hexavalent vaccines are also reviewed.

Keywords::

• combination
• Haemophilus influenzae type b
• hepatitis B
• hexavalent
• immunogenicity
• Infanrix hexa™
• pertussis
• safety
• vaccination

Financial & competing interests disclosure

Fred Zepp has received reimbursements from GlaxoSmithKline Biologicals for conference attendance; Fred Zepp and the Johannes Gutenberg University have also received, respectively, consulting fees and research funds from GlaxoSmithKline Biologicals. Heinz-Josef Schmitt has received research funds and consulting fees from GlaxoSmithKline Biologicals, Sanofi Pasteur-MSD and Wyeth, and is currently an employee of Novartis Vaccines. Jan Cleerbout, Thomas Verstraeten, Lode Schuerman and Jeanne-Marie Jacquet are employees of GlaxoSmithKline Biologicals. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Writing assistance was utilized in the production of this manuscript. Assistance in preparing the manuscript was provided by Alpharmaxim Healthcare Communications (UK). Funding for the preparation of the manuscript was provided by GlaxoSmithKline Biologicals.