tetano
Editor, Senior Moderator
Expert Rev Vaccines. 2016 Nov 24. [Epub ahead of print]
[h=1]Rapid assessment of the reactogenicity of a 2016-2017 seasonal influenza vaccine: results from a feasibility study.[/h] Stuurman AL[SUP]1[/SUP], Verstraeten T[SUP]1[/SUP], De Schryver A[SUP]2[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] The European Medicines Agency (EMA) calls for a strategy for enhanced safety surveillance of seasonal influenza vaccines.
[h=4]OBJECTIVE:[/h] We assessed the feasibility of collecting reactogenicity data within one month of the start of the vaccination campaign in Belgium.
[h=4]METHODS:[/h] 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.
[h=4]RESULTS:[/h] 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.
[h=4]CONCLUSION:[/h] 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.
[h=4]KEYWORDS:[/h] European Medicines Agency guidance; adults; enhanced safety surveillance; reactogenicity; seasonal influenza vaccine
PMID: 27882801 DOI: 10.1080/14760584.2017.1264272
[PubMed - as supplied by publisher]
[h=1]Rapid assessment of the reactogenicity of a 2016-2017 seasonal influenza vaccine: results from a feasibility study.[/h] Stuurman AL[SUP]1[/SUP], Verstraeten T[SUP]1[/SUP], De Schryver A[SUP]2[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] The European Medicines Agency (EMA) calls for a strategy for enhanced safety surveillance of seasonal influenza vaccines.
[h=4]OBJECTIVE:[/h] We assessed the feasibility of collecting reactogenicity data within one month of the start of the vaccination campaign in Belgium.
[h=4]METHODS:[/h] 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.
[h=4]RESULTS:[/h] 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.
[h=4]CONCLUSION:[/h] 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.
[h=4]KEYWORDS:[/h] European Medicines Agency guidance; adults; enhanced safety surveillance; reactogenicity; seasonal influenza vaccine
PMID: 27882801 DOI: 10.1080/14760584.2017.1264272
[PubMed - as supplied by publisher]