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Title
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Rapid assessment of the reactogenicity of a 2016-2017 seasonal influenza vaccine : results from a feasibility study
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Author
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Abstract
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| Background: The European Medicines Agency (EMA) calls for a strategy for enhanced safety surveillance of seasonal influenza vaccines. Objective: We assessed the feasibility of collecting reactogenicity data within one month of the start of the vaccination campaign in Belgium. Methods: One hundred subjects aged 18 to 65 years who had received inactivated seasonal influenza vaccine in occupational setting were enrolled. For 7 days after vaccination, subjects received a daily SMS with a link to a web-based questionnaire where reactogenicity events and their severity were solicited. Results: Data collection was completed by October 13th, 2016, before the peak of the vaccination campaign in Belgium. 68% of participants reported a local reaction and 65% a general reaction; 51% reported both a local and a general reaction. Conclusion: Here we show that it has been possible to collect reactogenicity data in adults for enhanced safety surveillance in Belgium in a timely manner. The observed reactogenicity is higher compared to previous observations for this vaccine measured in clinical trials. |
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Language
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English
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Source (journal)
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Expert review of vaccines. - Place of publication unknown
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Publication
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Place of publication unknown
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2016
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ISSN
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1476-0584
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DOI
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10.1080/14760584.2017.1264272
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Volume/pages
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16
:2
(2016)
, p. 187-191
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ISI
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000392988900010
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Full text (Publisher's DOI)
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Full text (open access)
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Full text (publisher's version - intranet only)
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