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

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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.

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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

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Acknowledgements

Participating investigators: Drs J. Banz, U. Behre, K. Bennett, F. Bertholdt, H. Berwanger, H. Bolze-Knothe, H-M. Burow, M. Collet, J. Disselhoff, Z. Dogrul, F-P. Drobnitzky, R. Erdl, R. Freund, F. Gamerdinger, W. Geltinger, PK. Gildberg, H. Glaser, D. Goepel-Abtt, S. Habash, H. Hake, U. Hammermüller, T. Hangen, K. Hecker, D. Herrmann, R. Holtorf, W. Hultzsch, HF Hüsgen, H. Johannsen, K. Karsten, K. Kirsten, B-M. Kniese, H. Krause, K-H. Krause, M. Krause, K-H. Laakmann, H-P. Loch, HH. Mahler, D. Manegold-Randel, MJ. Matting-Köhler, L. Maurer, T. Menke, S. Mohns-Petersen, C. Möllering, J. Monninger, B. Netzel, H. Outzen, H. Pankow-Culot, A. Paulus-Koschik, H. Preidel, C. Rüdiger, B. Protzmann, V. Reschke, L. Sander, S. Scharfe, E. Schmitz-Hauss, R. Schult, L. Seitz, C. Sievers, J. Stock, P. Soemantri, U. Sträubler, S. Strauch, K-J. Taube, D. Weyandt, C. Wittermann, R. Wollmerstädt, F. Zepp and B. zu Castell Rüdenhausen.

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Authors and Affiliations

  1. GlaxoSmithKline GmbH & Co. KG, Theresienhoehe 11, 80339, Munich, Germany

    Roland Sänger

  2. Medical Practice Kehl, Kehl, Germany

    Ulrich Behre

  3. Medical Practice Goch, Goch, Germany

    Karl-Heinz Krause

  4. Medical Practice Wolfenbüttel, Wolfenbüttel, Germany

    Hans-Peter Loch

  5. Medical Practice, Kleve-Materborn, Kleve-Materborn, Germany

    Peter Soemantri

  6. Medical Practice Salzgitter, Salzgitter, Germany

    Dietmar Herrmann

  7. Medical Practice Willich, Willich, Germany

    Eugenie Schmitz-Hauss

  8. GlaxoSmithKline Biologicals, Rue de l’institut 89, Rixensart, 1330, Belgium

    Joanne Wolter & Bernard Hoet

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  1. Roland Sänger
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  2. Ulrich Behre
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  3. Karl-Heinz Krause
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Correspondence to Roland Sänger.

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Source of financial support: GlaxoSmithKline Biologicals, Rixensart, Belgium.

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Sänger, R., Behre, U., Krause, KH. et al. Booster vaccination and 1-year follow-up of 4–8-year-old children with a reduced-antigen-content dTpa-IPV vaccine. Eur J Pediatr 166, 1229–1236 (2007). https://doi.org/10.1007/s00431-006-0403-x

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  • DOI: https://doi.org/10.1007/s00431-006-0403-x

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