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Randomised controlled trial showed long‐term efficacy, immunogenicity and safety of varicella vaccines in Norwegian and Swedish children
AIM: Several countries, such as Norway and Sweden, have not implemented universal varicella vaccination. We present data for Norway and Sweden that were generated by a paediatric multi‐country Phase III study over a 10‐year period. This assessed the efficacy, antibody persistence and safety of two v...
Autores principales: | , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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John Wiley and Sons Inc.
2021
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9297935/ https://www.ncbi.nlm.nih.gov/pubmed/34606114 http://dx.doi.org/10.1111/apa.16136 |
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author | Casabona, Giacomo Habib, Md Ahsan Povey, Michael Riise Bergsaker, Marianne A. Flodmark, Carl‐Erik Espnes, Ketil Arne Tøndel, Camilla Silfverdal, Sven‐Arne |
author_facet | Casabona, Giacomo Habib, Md Ahsan Povey, Michael Riise Bergsaker, Marianne A. Flodmark, Carl‐Erik Espnes, Ketil Arne Tøndel, Camilla Silfverdal, Sven‐Arne |
author_sort | Casabona, Giacomo |
collection | PubMed |
description | AIM: Several countries, such as Norway and Sweden, have not implemented universal varicella vaccination. We present data for Norway and Sweden that were generated by a paediatric multi‐country Phase III study over a 10‐year period. This assessed the efficacy, antibody persistence and safety of two varicella vaccines containing the same Oka strain. METHODS: This was an observer‐blind, controlled trial conducted in 10 European countries. Children aged 12–22 months (n = 5803) were randomised 3:3:1 and vaccinated between 1 September 2005 and 10 May 2006. The two‐dose group received two tetravalent measles‐mumps‐rubella‐varicella vaccine doses. The one‐dose group received one monovalent varicella vaccine dose after a measles‐mumps‐rubella vaccine dose. Control group participants received two measles‐mumps‐rubella vaccine doses. Main study outcomes were vaccine efficacy against confirmed varicella cases and incidence of adverse events. RESULTS: Vaccine efficacy in the two‐dose group was ≥92.1% in both Norwegian and Swedish children compared to 72.3% in Norway and 58.0% in Sweden in the one‐dose group. Incidences of adverse events and serious adverse events were similar in the Norwegian and Swedish study populations. CONCLUSION: Consistent with overall study results, high efficacy against varicella and acceptable safety profiles of the two varicella vaccines were observed in Norwegian and Swedish populations. These findings highlight the benefits of varicella vaccines, particularly when administered as a two‐dose schedule. |
format | Online Article Text |
id | pubmed-9297935 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-92979352022-07-21 Randomised controlled trial showed long‐term efficacy, immunogenicity and safety of varicella vaccines in Norwegian and Swedish children Casabona, Giacomo Habib, Md Ahsan Povey, Michael Riise Bergsaker, Marianne A. Flodmark, Carl‐Erik Espnes, Ketil Arne Tøndel, Camilla Silfverdal, Sven‐Arne Acta Paediatr Regular Articles & Brief Reports AIM: Several countries, such as Norway and Sweden, have not implemented universal varicella vaccination. We present data for Norway and Sweden that were generated by a paediatric multi‐country Phase III study over a 10‐year period. This assessed the efficacy, antibody persistence and safety of two varicella vaccines containing the same Oka strain. METHODS: This was an observer‐blind, controlled trial conducted in 10 European countries. Children aged 12–22 months (n = 5803) were randomised 3:3:1 and vaccinated between 1 September 2005 and 10 May 2006. The two‐dose group received two tetravalent measles‐mumps‐rubella‐varicella vaccine doses. The one‐dose group received one monovalent varicella vaccine dose after a measles‐mumps‐rubella vaccine dose. Control group participants received two measles‐mumps‐rubella vaccine doses. Main study outcomes were vaccine efficacy against confirmed varicella cases and incidence of adverse events. RESULTS: Vaccine efficacy in the two‐dose group was ≥92.1% in both Norwegian and Swedish children compared to 72.3% in Norway and 58.0% in Sweden in the one‐dose group. Incidences of adverse events and serious adverse events were similar in the Norwegian and Swedish study populations. CONCLUSION: Consistent with overall study results, high efficacy against varicella and acceptable safety profiles of the two varicella vaccines were observed in Norwegian and Swedish populations. These findings highlight the benefits of varicella vaccines, particularly when administered as a two‐dose schedule. John Wiley and Sons Inc. 2021-10-28 2022-02 /pmc/articles/PMC9297935/ /pubmed/34606114 http://dx.doi.org/10.1111/apa.16136 Text en © 2021 GlaxoSmithKline Biologicals S.A. Acta Paediatrica published by John Wiley & Sons Ltd on behalf of Foundation Acta Paediatrica. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes. |
spellingShingle | Regular Articles & Brief Reports Casabona, Giacomo Habib, Md Ahsan Povey, Michael Riise Bergsaker, Marianne A. Flodmark, Carl‐Erik Espnes, Ketil Arne Tøndel, Camilla Silfverdal, Sven‐Arne Randomised controlled trial showed long‐term efficacy, immunogenicity and safety of varicella vaccines in Norwegian and Swedish children |
title | Randomised controlled trial showed long‐term efficacy, immunogenicity and safety of varicella vaccines in Norwegian and Swedish children |
title_full | Randomised controlled trial showed long‐term efficacy, immunogenicity and safety of varicella vaccines in Norwegian and Swedish children |
title_fullStr | Randomised controlled trial showed long‐term efficacy, immunogenicity and safety of varicella vaccines in Norwegian and Swedish children |
title_full_unstemmed | Randomised controlled trial showed long‐term efficacy, immunogenicity and safety of varicella vaccines in Norwegian and Swedish children |
title_short | Randomised controlled trial showed long‐term efficacy, immunogenicity and safety of varicella vaccines in Norwegian and Swedish children |
title_sort | randomised controlled trial showed long‐term efficacy, immunogenicity and safety of varicella vaccines in norwegian and swedish children |
topic | Regular Articles & Brief Reports |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9297935/ https://www.ncbi.nlm.nih.gov/pubmed/34606114 http://dx.doi.org/10.1111/apa.16136 |
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