A DTaP–IPV//PRP∼T vaccine (Pentaxim™): a review of 16 years’ clinical experience

Abstract

Owing to their low reactogenicity, confirmed efficacy and availability in combination vaccines, acellular pertussis (aP)-inactivated poliovirus (IPV) combined vaccines are now included in various national immunization programs worldwide. We provide an overview of 16 years of clinical experience with a diphtheria (D), tetanus (T), aP, IPV and Haemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (PRP∼T) combined vaccine (DTaP-IPV//PRP∼T - Pentaxim, Sanofi Pasteur, France). Good immunogenicity has been demonstrated after primary vaccination with Pentaxim, regardless of the population ethnicity and primary vaccination schedule. A booster vaccination in the second year of life also resulted in a high immune response for each antigen. Furthermore, 10 years of national surveillance in Sweden has demonstrated the effectiveness of Pentaxim in controlling pertussis. As is the case for other aP-containing combined vaccines, Pentaxim is well tolerated, with the safety profile being better than for whole-cell pertussis-containing combination vaccines for primary and booster vaccinations.

A fully liquid DTaP-IPV-HB-PRP-T hexavalent vaccine for primaryand booster vaccination of healthy Turkish infants and toddlers*

“…In this context, Sanofi Pasteur has built on the wide experience with Pentaxim/ Pentavac, an established pediatric pentavalent diphtheria (D), tetanus (T), aP, IPV, and Hemophilus influenzae type b (PRP-T) vaccine (4), to develop a fully liquid, hexavalent DTaP-IPV-hepatitis B (HB)-PRP-T vaccine (Hexaxim/Hexyon/Hexacima) that has the same D, T, aP, IPV, and PRP-T composition as Pentaxim/Pentavac. Additionally, the hexavalent vaccine incorporates a HB antigen of proven immunogenicity and safety (5)(6)(7)(8).…”

Combined Vaccine Is an Effective and Safe Protection From Five Controllable Infections

“…[5]. Pentavalent vaccine Pentaxim (Sanofi Pasteur, France), which contains diphtherial and tetanus toxoids, acellular pertussis component (DTaP), inactivated poliovirus (IPV) and type b Haemophilus influenzae (Hib), was licensed in 1997 in Sweden [2,6]. It is the first pentavalent vaccine with acellular pertussis component used all over the world; it is introduced into vaccination schedules both for primary vaccination (0-1 years of age) and for revaccination (1-2 years of age).…”

“…1); however, tolerance to the drug and vaccination with separate monocomponent vaccines depending on frequency of administration thereof (tb. 2) and generation of specific antibodies has been compared [6][7][8][9]. General safety of the pentavalent vaccine with acellular pertussis component has been evaluated in comparison with whole cell vaccine.…”

“…General safety of the pentavalent vaccine with acellular pertussis component has been evaluated in comparison with whole cell vaccine. Decreased rate of postvaccinal reactions has been observed; moreover, febrile convulsions were registered 79% less frequently in Canada in the process of primary vaccination and after revaccination, intracranial pressure increase -60-67% less frequently [6]. 14 clinical trials have been conducted in 9 countries; they demonstrated high tolerance to the vaccine; focal reactions (reddening, edema, injection site thickening, tenderness) were rare.…”

“…Comparative studies of tolerance to the pentavalent vaccine in combination with a recombinant hepatitis B vaccine and to vaccination with inactivated poliovirus, acellular pertussis-diphtheria-tetanus vaccine and conjugate Hib vaccine (Hib) demonstrated equivalent tolerance to the immunization. Several studies [6,7,9] demonstrated immunogenicity of the pentavalent vaccine: protective antibody titer against diphtheria and tetanus (more than 0.01 IU/ml) developed in 92.2-100% of children after the primary vaccination, against type 1, 2 and 3 poliomyelitis -in 99.6-100% of children. Type b Haemophilus influenzae antibodies could be observed 1 month after the third administration of the vaccine in 92-100% of cases (according to different authors) [6][7][8][9].…”