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Published online: 22 January 2013
© Springer International Publishing Switzerland 2013
Abstract Hexaxim® (DTaP-IPV-Hep B-Hib) is a new, thiomersal-free, fully liquid, hexavalent combination pediatric vaccine containing diphtheria and tetanus toxoids, acellular pertussis, inactivated poliovirus, recombinant hepatitis B virus surface antigen produced in the yeast Hansenula polymorpha, and Haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate) conjugated to tetanus toxoid. It is currently registered in markets outside of the EU for primary vaccination of infants from 6 weeks of age and for booster vaccination up to 24 months of age. In randomized controlled trials, primary vaccination of infants with Hexaxim® using various immunization schedules was highly immunogenic for all vaccine component antigens regardless of the administration schedule, producing high levels of seroprotection or seroconversion for each antigen.Hexaxim®was as immunogenic as the comparator DTwP-or DTaP-based vaccines in these studies. The serological responses were generally sustained at high levels over a follow-up of [asymptotically =]1 year, and booster vaccination at 15-18 months further enhanced the immune response. Hexaxim® was less reactogenic than a DTwP-based combination vaccine, and displayed a tolerability profile similar to those of the comparator DTaP-based combination vaccines. Thus, Hexaxim® provides effective seroprotection or seroconversion against six major childhood diseases simultaneously, both as primary and booster vaccination, and offers the benefits and convenience of a fully liquid, ready-to-use vaccine
Keywords: Hexaxim®, diphtheria, tetanus, acellular pertussis, inactivated poliovirus, hepatitis B, Haemophilus influenzae type b, DTaP-IPV-Hep B-Hib vaccine, infants, immunogenicity, reactogenicity.
1 Introduction
The WHO currently recommends routine immunization of infants against a range of infectious diseases, including diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, and invasive Haemophilus influenzae type b infections [1]. Administering different vaccines at the same time simplifies immunization schedules and maximizes coverage; thus, WHO recommends administering the aforementioned vaccines during the same visits [1].
Combination vaccines minimize the number of injections required, reduce costs, and potentially increase compliance, and so have become standard in routine pediatric practice [2]. The valences of combination pediatric vaccines vary, with many being based on a combination of diphtheria (D) and tetanus (T) toxoids, and acellular pertussis (aP) as the core to which other vaccines have been added [2]. These DTaP vaccines are gradually replacing the equivalent whole-cell pertussis vaccines (DTwP), since they are less reactogenic [3]. DTaP...