DTaP5-HB-IPV-Hib Vaccine (Vaxelis®): A Review of its Use in Primary and Booster Vaccination.

Abstract

Vaxelis® is a fully liquid, ready-to-use, hexavalent vaccine approved in the EU for primary and booster vaccination in infants and toddlers from the age of 6 weeks against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, and invasive diseases caused by Haemophilus influenzae type b (Hib). It contains diphtheria and tetanus toxoids, five acellular pertussis antigens, recombinant hepatitis B virus surface antigen produced in the yeast, Saccharomyces cerevisiae, inactivated poliovirus, and the Hib polysaccharide (polyribosylribitol phosphate) conjugated to the outer membrane protein complex of Neisseria meningitidis. In pivotal clinical studies, Vaxelis® was highly immunogenic for all its component toxoids/antigens when administered by three different schedules. Primary endpoints of seroprotection or vaccine response rates with Vaxelis® met the predefined acceptability criteria and were noninferior to those with comparator vaccines (Infanrix®hexa or Pentacel® plus Recombivax HB®). Limited data indicate that immune responses to Vaxelis® in preterm infants were generally similar to those seen in the overall population. Vaxelis® can be coadministered with a number of common childhood vaccines. In clinical studies, Vaxelis® was generally well tolerated with a tolerability profile similar to that of the comparator vaccines. Available clinical data indicate that Vaxelis® is a new hexavalent vaccine option for immunization against several serious childhood infectious diseases.