Post-marketing Surveillance of a Quadrivalent Influenza Vaccine (Vaxigrip Tetra) in South Korea.

ABSTRACT:

Introduction

In 2017, a quadrivalent inactivated split-virion influenza vaccine (QIV; Vaxigrip Tetra^®, Sanofi) was licensed in South Korea for active immunization against influenza A and influenza B viruses in individuals aged 3 years or older, which was subsequently extended to individuals aged 6 months or older in 2018. Post-marketing surveillance trials are mandatory in South Korea to retain drug licensure. Here, we assessed the safety of QIV in routine clinical practice in South Korea.

Methods

This was an open, multicenter, observational, active safety surveillance study conducted between 20 June 2017 and 19 June 2021 at 10 study sites in South Korea in individuals aged 3 years or older who received a single dose of QIV during a routine healthcare visit. The p

SUBMITTER: Lim S 

PROVIDER: S-EPMC9450834 | biostudies-literature | 2022 Oct

REPOSITORIES: biostudies-literature