Randomised controlled trial showed long-term efficacy, immunogenicity and safety of varicella vaccines in Norwegian and Swedish children.

Autor: Casabona G; GSK, Wavre, Belgium., Habib MA; GSK, Wavre, Belgium., Povey M; GSK, Wavre, Belgium., Riise Bergsaker MA; The Norwegian Institute of Public Health, Oslo, Norway., Flodmark CE; Department of Paediatrics, Skåne University Hospital, Malmö, Sweden., Espnes KA; Risvollan Legesenter, Trondheim, Norway., Tøndel C; Department of Paediatrics, Haukeland University Hospital, Bergen, Norway., Silfverdal SA; Department of Clinical Sciences, Paediatrics, Umeå University, Umeå, Sweden.
Jazyk: angličtina
Zdroj: Acta paediatrica (Oslo, Norway : 1992) [Acta Paediatr] 2022 Feb; Vol. 111 (2), pp. 391-400. Date of Electronic Publication: 2021 Oct 28.
DOI: 10.1111/apa.16136
Abstrakt: 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.
(© 2021 GlaxoSmithKline Biologicals S.A. Acta Paediatrica published by John Wiley & Sons Ltd on behalf of Foundation Acta Paediatrica.)
Databáze: MEDLINE
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