Post-authorisation passive enhanced safety surveillance of seasonal influenza vaccines: protocol of a pilot study in England

AIM: To pilot enhanced safety surveillance of seasonal influenza vaccine meeting the European Medicines Agency (EMA) requirement to rapidly detect a significant increase in the frequency or severity of adverse events of interest (AEIs), which may indicate risk from the new season’s vaccine. STUDY DE...

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Bibliographic Details
Published in:BMJ Open
Main Authors: de Lusignan, Simon, Dos Santos, Gaël, Correa, Ana, Haguinet, François, Yonova, Ivelina, Lair, Florence, Byford, Rachel, Ferreira, Filipa, Stuttard, Karen, Chan, Tom
Format: Artigo
Language:Inglês
Published: BMJ Open 2017
Subjects:
Epidemiology
Online Access:https://ncbi.nlm.nih.gov/pmc/articles/PMC5541341/
https://ncbi.nlm.nih.gov/pubmed/28515198
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1136/bmjopen-2016-015469
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