Randomised controlled trial showed long‐term efficacy, immunogenicity and safety of varicella vaccines in Norwegian and Swedish children
| Autor: | Ketil Arne Espnes, Carl-Erik Flodmark, Camilla Tøndel, Marianne A. Riise Bergsaker, Michael Povey, Giacomo Casabona, Sven Arne Silfverdal, Ahsan Habib |
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| Rok vydání: | 2021 |
| Předmět: |
safety
Pediatrics medicine.medical_specialty Varicella vaccine efficacy varicella vaccine Vaccine Efficacy Norwegian Varicella vaccination Antibodies Viral law.invention Chickenpox Vaccine Chickenpox Randomized controlled trial law medicine Humans Child Adverse effect Sweden Norway business.industry Immunogenicity Incidence (epidemiology) Pediatrik Immunology in the medical area Infant virus diseases General Medicine Vaccine efficacy language.human_language Immunologi inom det medicinska området Pediatrics Perinatology and Child Health language business Measles-Mumps-Rubella Vaccine |
| Zdroj: | Acta Paediatrica. 111:391-400 |
| ISSN: | 1651-2227 0803-5253 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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