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Randomised controll...
Randomised controlled trial showed long-term efficacy, immunogenicity and safety of varicella vaccines in Norwegian and Swedish children
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- Casabona, Giacomo (author)
- GSK, Wavre, Belgium,GlaxoSmithKline Pharmaceuticals SA
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- Habib, Md Ahsan (author)
- GSK, Wavre, Belgium,GlaxoSmithKline Pharmaceuticals SA
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- Povey, Michael (author)
- GSK, Wavre, Belgium,GlaxoSmithKline Pharmaceuticals SA
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- Riise Bergsaker, Marianne A. (author)
- The Norwegian Institute of Public Health, Oslo, Norway
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- Flodmark, Carl Erik (author)
- Lund University,Lunds universitet,Preventiv pediatrik,Forskargrupper vid Lunds universitet,Preventive Paediatrics,Lund University Research Groups,Skåne University Hospital
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- Espnes, Ketil Arne (author)
- Risvollan Legesenter, Trondheim, Norway; Department of Clinical Pharmacology, St. Olav’s Hospital, Trondheim University Hospital, Trondheim, Norway
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- Tøndel, Camilla (author)
- Department of Paediatrics, Haukeland University Hospital, Bergen, Norway
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- Silfverdal, Sven-Arne (author)
- Umeå University,Umeå universitet,Pediatrik
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(creator_code:org_t)
- 2021-10-28
- 2022
- English.
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In: Acta Paediatrica. - : John Wiley & Sons. - 0803-5253 .- 1651-2227. ; 111:2, s. 391-400
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Abstract
Subject headings
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- 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.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Pediatrik (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Pediatrics (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Medicinska och farmaceutiska grundvetenskaper -- Immunologi inom det medicinska området (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Basic Medicine -- Immunology in the medical area (hsv//eng)
Keyword
- efficacy
- Norway
- safety
- Sweden
- varicella vaccine
- efficacy
- Norway
- safety
- Sweden
- varicella vaccine
Publication and Content Type
- ref (subject category)
- art (subject category)
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