Abstract
Vaxelis® (DTaP5-HB-IPV-Hib vaccine) is a fully liquid, ready-to-use, hexavalent vaccine containing diphtheria toxoid, tetanus toxoid, five acellular pertussis antigens, hepatitis B surface antigen, inactivated poliovirus and the Haemophilus influenzae type b capsular polysaccharide polyribosylribitol phosphate conjugated to the outer membrane protein complex of Neisseria meningitidis. In pivotal clinical studies in infants and toddlers, Vaxelis® was highly immunogenic for all its component toxoids/antigens when administered by three different schedules. In general, 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® + Recombivax HB®). 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.
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Acknowledgements
The manuscript was adapted from Pediatric Drugs 2017;19(1):69–90 [19], and was reviewed by: G. Gabutti, Department of Medical Sciences, University of Ferrara, Ferrara, Italy; G. Icardi, Department of Health Sciences, University of Genoa, Genoa, Italy; Y. Kino, Chemo-Sero-Therapeutic Research Institute, Kumamoto, Japan. During the peer review process, the manufacturer of Vaxelis® was also offered an opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.
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The preparation of this review was not supported by any external funding.
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G.M. Keating, K.A. Williamson-Lyseng and Y.Y. Syed were/are salaried employees of Adis/Springer, are responsible for the article content and declare no conflicts of interest.
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Keating, G.M., Lyseng-Williamson, K.A. & Syed, Y.Y. Vaxelis® (DTaP5-HB-IPV-Hib vaccine) as primary and booster vaccination in infants and toddlers: a profile of its use. Drugs Ther Perspect 33, 208–213 (2017). https://doi.org/10.1007/s40267-017-0400-3
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DOI: https://doi.org/10.1007/s40267-017-0400-3