Open-label, randomised, parallel-group, multicentre study to evaluate the safety, tolerability and immunogenicity of an AS03B/oil-in-water emulsion-adjuvanted (AS03B) split-virion versus non-adjuvanted whole-virion H1N1 influenza vaccine in UK children 6 months to 12 years of age
| Autor: | CS Waddington, N Andrews, K Hoschler, WT Walker, C Oeser, A Reiner, T John, S Wilkins, M Casey, PE Eccleston, RJ Allen, I Okike, S Ladhani, E Sheasby, P Waight, AC Collinson, PT Heath, A Finn, SN Faust, MD Snape, E Miller, AJ Pollard |
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| Jazyk: | angličtina |
| Rok vydání: | 2010 |
| Předmět: | |
| Zdroj: | Health Technology Assessment, Vol 14, Iss 46 (2010) |
| Druh dokumentu: | article |
| ISSN: | 1366-5278 2046-4924 |
| DOI: | 10.3310/hta14460-01 |
| Popis: | Objective: To evaluate the safety, tolerability and immunogenicity of an AS03B/oil-in-water emulsion-adjuvanted (AS03B) split-virion versus non-adjuvanted whole-virion H1N1 influenza vaccine in UK children aged 6 months to 12 years. Design: Multicentre, randomised, head-to-head, open-label trial. Setting: Five UK sites (Oxford, Bristol, Southampton, Exeter and London). Participants: Children aged 6 months to 38.0°C in those under 5 years of age (8.9% vs 22.4%). Conclusion: The adjuvanted vaccine, although reactogenic, was more immunogenic, especially in younger children, indicating the potential for improved immunogenicity of influenza vaccines in this age group. Trial registration number: ISRCTN89141709 |
| Databáze: | Directory of Open Access Journals |
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