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Safety, immunogenicity and immediate pain of intramuscular versus subcutaneous administration of a measles–mumps–rubella–varicella vaccine to children aged 11–21 months

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Abstract

This study compared intramuscular and subcutaneous administration of two doses of measles–mumps–rubella–varicella (MMRV) combination vaccine (Priorix-Tetra™, GlaxoSmithKline Biologicals) in children. Healthy children (N = 328) were randomised to receive MMRV either intramuscularly or subcutaneously. Reactogenicity was similar between treatment groups for immediate vaccination pain, vaccination site pain, redness and incidence of fever and rashes. Slightly less vaccination site swelling occurred during days 0–3 of the post-vaccination period after intramuscular administration. Seroconversion rates for all components, 42–56 days post-dose 2, ranged from 99.3% to 100% in the intramuscular group and from 98.6% to 100% in the subcutaneous. Cell-mediated immunity data supported the humoral immunogenicity findings. In summary, the MMRV vaccine is well tolerated and highly immunogenic when administered either subcutaneously or intramuscularly to children in the second year of life.

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Acknowledgements

The authors would like to thank the parents, children and investigators who participated in this clinical trial. We also gratefully acknowledge the work of the nurses and other staff members involved. Wilhelm Warncke (GSK Germany) conducted the statistical analyses. Doug McConnell and Lucy Broom (SciNopsis) provided medical writing services. Dr. Catherine Arnaudeau-Bégard and Dr. Marie Bayle-Normand (GSK Biologicals) coordinated the publication. This study was funded by GlaxoSmithKline Biologicals. Priorix-Tetra and Priorix are trademarks of the GlaxoSmithKline group of companies.

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Authors and Affiliations

  1. Children’s Hospital, Dr. Horst Schmidt Klinik, Ludwig-Erhard-Str. 100, Wiesbaden, 65199, Germany

    Markus Knuf

  2. Department of Pediatrics, Johannes Gutenberg-University, Langenbeckstr. 1, Mainz, 55101, Germany

    Markus Knuf, Fred Zepp & Claudius U. Meyer

  3. Pediatric Office, Mainz, Germany

    Pirmin Habermehl

  4. Pediatric Office, Frankenthal, Germany

    Lothar Maurer

  5. Pediatric Office, Oberkirch, Germany

    Hanns-Michael Burow

  6. Pediatric Office, Kehl, Germany

    Ulrich Behre

  7. GlaxoSmithKline Biologicals, Rixensart, Belgium

    Michel Janssens & Paul Willems

  8. GlaxoSmithKline, Munich, Germany

    Helmtrud Bisanz, Volker Vetter & Ruprecht Schmidt-Ott

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  1. Markus Knuf
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  2. Fred Zepp
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  3. Claudius U. Meyer
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Correspondence to Markus Knuf.

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Knuf, M., Zepp, F., Meyer, C.U. et al. Safety, immunogenicity and immediate pain of intramuscular versus subcutaneous administration of a measles–mumps–rubella–varicella vaccine to children aged 11–21 months. Eur J Pediatr 169, 925–933 (2010). https://doi.org/10.1007/s00431-010-1142-6

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  • DOI: https://doi.org/10.1007/s00431-010-1142-6

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