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

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 profi...

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Bibliographic Details
Published in:Infectious diseases and therapy 2020-09, Vol.9 (3), p.589-598
Main Authors: Kim, Hee Soo, Oh, Yongho, Korejwo, Joanna, Castells, Valérie Bosch, Yang, Kuhyun
Format: Article
Language:English
Subjects:
Encephalitis
Health aspects
Immunization
Infectious Diseases
Internal Medicine
Japanese encephalitis
Live-attenuated Japanese encephalitis chimeric virus vaccine
Marketing
Medicine
Medicine & Public Health
Original Research
Safety
Side effects
Surveillance
Vaccination
Vaccine
Vaccines
Vector-borne diseases
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Summary: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 serious adverse events within 42 days after vaccination. Results Overall, 810 subjects who received JE-CV were included in our analysis, the majority received the vaccine as a primary vaccination (94.9%; 769/810). There were 179 solicited reactions reported by 111 subjects; the majority of solicited reactions occurred within 0–3 days (80.4%; 144/179), were of 1–3 days’ duration (79.3%; 142/179) and of grade 1 intensity (70.9%; 127/179). There were three grade 3 adverse reactions (irritability, pyrexia and malaise); all resolved within a few days. The incidence of solicited reactions were highest in those aged 12 to 
ISSN:2193-8229
2193-6382
DOI:10.1007/s40121-020-00305-6