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Enhanced passive safety surveillance of the quadrivalent inactivated split-virion influenza vaccine (IIV4) in Finland during the 2019/20 influenza season

Crossref DOI link: https://doi.org/10.1186/s12889-021-10378-8

Published Online: 2021-02-15

Published Print: 2021-12

Update policy: https://doi.org/10.1007/springer_crossmark_policy

Authors

Chabanon, Anne-Laure

Wague, Sophie

Moureau, Annick

Nissila, Markku

Serradell, Laurence https://orcid.org/0000-0003-3683-8086
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Text and Data Mining valid from 2021-02-15

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Article History

Received: 3 September 2020

Accepted: 3 February 2021

First Online: 15 February 2021

Ethics approval and consent to participate

: As a passive surveillance system, the EPSS requires no informed consent. No sensitive data were collected about the vaccinees, and no ethics committee submission was required in Finland for the EPSS. This surveillance was conducted in accordance with the EMA/PRAC/222346/2014 interim guidance on enhanced safety surveillance for seasonal influenza vaccines in the EU [].

: Not applicable.

: ALC, SW, and AM are employed by Sanofi Pasteur.MN is employed by Suomen Terveystalo, and has received investigator fees from Amgen, Asarina Pharma, Eli Lilly, GSK and Teva.LS is a contractor employed by Sanofi Pasteur.

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