Post-Marketing Surveillance of Adverse Events Following Vaccination with the Live-Attenuated Japanese Encephalitis Chimeric Virus Vaccine (Imojev^®) in South Korea, 2015-2019.

ABSTRACT:

Introduction

The live attenuated Japanese encephalitis chimeric virus vaccine (JE-CV; Imojev^®) has been approved in South Korea for use in subjects aged ≥ 12 months since 2015. As part of the license agreement, a post-marketing surveillance study was undertaken to actively monitor the safety profile of JE-CV in the Korean population.

Methods

An observational, active safety surveillance study was conducted from 3 April 2015 through to 2 April 2019 at 12 centers in South Korea. Subjects aged ≥ 12 months who received a single dose of JE-CV (primary or booster) during a routine healthcare visit were recruited and followed up for solicited reactions (7 and 14 days for injection site and systemic reactions, respectively), non-serious unsolicited adverse events and serio

SUBMITTER: Kim HS 

PROVIDER: S-EPMC7452989 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature