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A liquid hexavalent combined vaccine against diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type B and hepatitis B: review of immunogenicity and safety

Mallet, E; Belohradsky, BH; Lagos, R; Gothefors, L; Camier, P; Carriere, JP; Kanra, G; Hoffenbach, A; Langue, J and Undreiner, F, et al. (2004) In Vaccine 22(11-12). p.1343-1357
Abstract
To reduce the number of injections needed to comply with paediatric vaccination requirements, a liquid, hexavalent vaccine (DTaP-IPV-PRP-T-HBs; Hexavac((R)); Aventis Pasteur MSD) has been developed for primary and booster vaccination of infants and toddlers. In extensive clinical studies, Hexavac((R)) has been shown to be highly immunogenic. Seroconversion or seroprotective titres of antibodies against all antigens were achieved in the majority of infants following a primary series of three doses administered at 1-2-month intervals from 2 months of age. Hexavac((R)) also induced immunologic memory, as evidenced by the anamnestic response to booster vaccination at 12-18 months of age. These responses were comparable with those seen... (More)
To reduce the number of injections needed to comply with paediatric vaccination requirements, a liquid, hexavalent vaccine (DTaP-IPV-PRP-T-HBs; Hexavac((R)); Aventis Pasteur MSD) has been developed for primary and booster vaccination of infants and toddlers. In extensive clinical studies, Hexavac((R)) has been shown to be highly immunogenic. Seroconversion or seroprotective titres of antibodies against all antigens were achieved in the majority of infants following a primary series of three doses administered at 1-2-month intervals from 2 months of age. Hexavac((R)) also induced immunologic memory, as evidenced by the anamnestic response to booster vaccination at 12-18 months of age. These responses were comparable with those seen following concomitant administration of Pentavac(TM) (DTaP-IPV//PRP-T) and monovalent hepatitis B vaccine (H-B-Vax(TM) II), and were also within the ranges observed for other relevant licensed vaccines. Clinical studies comparing the immunogenicity of Hexavac((R)) administered at either 2, 3 and 4 months or 2, 4 and 6 months demonstrated that it can be used by either vaccination schedule. A further study also supported the use of primary doses of Hexavac((R)) at 3 and 5 months with a booster at 12 months of age. Hexavac((R)) demonstrated a good reactogenicity and tolerability profile. The most frequently reported adverse events after both primary and booster doses were local reactions of redness and swelling/induration and a systemic response of mild fever, irrespective of the vaccine used for priming. Hexavac((R)) provided immunity against six important childhood diseases with a single injection at each visit. (C) 2003 Elsevier Ltd. All rights reserved. (Less)
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published
subject
keywords
combination vaccine, paediatric immunization, hepatitis B, Hib
in
Vaccine
volume
22
issue
11-12
pages
1343 - 1357
publisher
Elsevier
external identifiers
  • wos:000220821700002
  • pmid:15063556
  • scopus:11144357611
ISSN
1873-2518
DOI
10.1016/j.vaccine.2003.09.039
language
English
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yes
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ddab8886-f1c6-4606-98d3-4dd865d405da (old id 899074)
date added to LUP
2008-01-15 13:54:24
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2017-06-11 03:34:20
@article{ddab8886-f1c6-4606-98d3-4dd865d405da,
  abstract     = {To reduce the number of injections needed to comply with paediatric vaccination requirements, a liquid, hexavalent vaccine (DTaP-IPV-PRP-T-HBs; Hexavac((R)); Aventis Pasteur MSD) has been developed for primary and booster vaccination of infants and toddlers. In extensive clinical studies, Hexavac((R)) has been shown to be highly immunogenic. Seroconversion or seroprotective titres of antibodies against all antigens were achieved in the majority of infants following a primary series of three doses administered at 1-2-month intervals from 2 months of age. Hexavac((R)) also induced immunologic memory, as evidenced by the anamnestic response to booster vaccination at 12-18 months of age. These responses were comparable with those seen following concomitant administration of Pentavac(TM) (DTaP-IPV//PRP-T) and monovalent hepatitis B vaccine (H-B-Vax(TM) II), and were also within the ranges observed for other relevant licensed vaccines. Clinical studies comparing the immunogenicity of Hexavac((R)) administered at either 2, 3 and 4 months or 2, 4 and 6 months demonstrated that it can be used by either vaccination schedule. A further study also supported the use of primary doses of Hexavac((R)) at 3 and 5 months with a booster at 12 months of age. Hexavac((R)) demonstrated a good reactogenicity and tolerability profile. The most frequently reported adverse events after both primary and booster doses were local reactions of redness and swelling/induration and a systemic response of mild fever, irrespective of the vaccine used for priming. Hexavac((R)) provided immunity against six important childhood diseases with a single injection at each visit. (C) 2003 Elsevier Ltd. All rights reserved.},
  author       = {Mallet, E and Belohradsky, BH and Lagos, R and Gothefors, L and Camier, P and Carriere, JP and Kanra, G and Hoffenbach, A and Langue, J and Undreiner, F and Roussel, F and Reinert, P and Flodmark, Carl-Erik and Stojanov, S and Liese, J and Levine, MM and Munoz, A and Schodel, F and Hessel, L},
  issn         = {1873-2518},
  keyword      = {combination vaccine,paediatric immunization,hepatitis B,Hib},
  language     = {eng},
  number       = {11-12},
  pages        = {1343--1357},
  publisher    = {Elsevier},
  series       = {Vaccine},
  title        = {A liquid hexavalent combined vaccine against diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type B and hepatitis B: review of immunogenicity and safety},
  url          = {http://dx.doi.org/10.1016/j.vaccine.2003.09.039},
  volume       = {22},
  year         = {2004},
}