European Journal of Pediatrics

, Volume 166, Issue 12, pp 1229–1236

Booster vaccination and 1-year follow-up of 4–8-year-old children with a reduced-antigen-content dTpa-IPV vaccine

  • Roland Sänger
  • Ulrich Behre
  • Karl-Heinz Krause
  • Hans-Peter Loch
  • Peter Soemantri
  • Dietmar Herrmann
  • Eugenie Schmitz-Hauss
  • Joanne Wolter
  • Bernard Hoet
Original Paper

DOI: 10.1007/s00431-006-0403-x

Cite this article as:
Sänger, R., Behre, U., Krause, KH. et al. Eur J Pediatr (2007) 166: 1229. doi:10.1007/s00431-006-0403-x

Abstract

Reduced-antigen-content pertussis vaccines designed initially for booster vaccination of adolescents and adults can also be used to vaccinate pre-school age children. Combination vaccines, which reduce the number of administered injections, combine multiple antigens including inactivated poliovirus (IPV), which is recommended in this age group in some countries. This randomised, controlled study compared a combined diphtheria-tetanus-acellular pertussis-inactivated polio-containing booster vaccine, dTpa-IPV (Boostrix™ Polio, n = 822), to separately administered dTpa (Boostrix™) and IPV (IPV Mérieux™, n = 136) in 4–8-year-old children who had previously received four doses of DTPa. Additional serological assessment was performed 1 year after the booster dose. One month after vaccination, seroprotection/vaccine response rates were similar for both groups. At least 99.9% of the subjects had protective antibodies against diphtheria, tetanus and polio, and at least 90.1% had a vaccine response to pertussis antigens after dTpa-IPV. Reactogenicity of dTpa-IPV was comparable to dTpa + IPV. Fever and grade 3 loss of appetite occurred more commonly after dTpa-IPV, whereas swelling and grade 3 pain occurred more frequently after separately administered dTpa + IPV (P < 0.05 for all). However, 95% CIs overlapped in all cases. Large swelling reactions after dTpa-IPV occurred less commonly than have been reported after a fifth dose of DTPa. One year after the booster, 98.6% of the subjects tested continued to have protective antibodies against diphtheria, tetanus and polio, and at least 81.2% were seropositive for pertussis components. The reduced-antigen-content dTpa-IPV vaccine was immunogenic, well tolerated and safe in pre-school age children. It provides immunity against four diseases in a single injection, with the potential reactogenicity benefit of a reduced-antigen dose.

Keywords

Pertussis Vaccination Diphtheria Tetanus Booster 

Abbreviations

ATP

according to protocol

DTPa

diphtheria, tetanus and acellular pertussis vaccine

DTPw

diphtheria, tetanus and whole-cell pertussis vaccine

dTpa

reduced-antigen-content diphtheria, tetanus and acellular pertussis vaccine

IPV

inactivated polio virus

CI

confidence interval

GMC/T

geometric mean concentration/titre

OPV

oral polio vaccine

PT

pertussis toxin

FHA

filamentous haemagglutinin

PRN

pertactin

SAE

serious adverse event

Copyright information

© Springer-Verlag 2007

Authors and Affiliations

  • Roland Sänger
    • 1
  • Ulrich Behre
    • 2
  • Karl-Heinz Krause
    • 3
  • Hans-Peter Loch
    • 4
  • Peter Soemantri
    • 5
  • Dietmar Herrmann
    • 6
  • Eugenie Schmitz-Hauss
    • 7
  • Joanne Wolter
    • 8
  • Bernard Hoet
    • 8
  1. 1.GlaxoSmithKline GmbH & Co. KGMunichGermany
  2. 2.Medical Practice KehlKehlGermany
  3. 3.Medical Practice GochGochGermany
  4. 4.Medical Practice WolfenbüttelWolfenbüttelGermany
  5. 5.Medical Practice, Kleve-MaterbornKleve-MaterbornGermany
  6. 6.Medical Practice SalzgitterSalzgitterGermany
  7. 7.Medical Practice WillichWillichGermany
  8. 8.GlaxoSmithKline BiologicalsRixensartBelgium

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