Post-Marketing Surveillance of Adverse Events Following Vaccination with the Live-Attenuated Japanese Encephalitis Chime
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ORIGINAL RESEARCH
Post-Marketing Surveillance of Adverse Events Following Vaccination with the Live-Attenuated Japanese Encephalitis Chimeric Virus Vaccine (ImojevÒ) in South Korea, 2015–2019 Hee Soo Kim . Yongho Oh . Joanna Korejwo . Vale´rie Bosch Castells . Kuhyun Yang
Received: April 16, 2020 Ó The Author(s) 2020
ABSTRACT Introduction: The live attenuated Japanese encephalitis chimeric virus vaccine (JE-CV; ImojevÒ) has been approved in South Korea for use in subjects aged C 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 C 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 Digital Features To view digital features for this article go to https://doi.org/10.6084/m9.figshare.12328265. Electronic supplementary material The online version of this article (https://doi.org/10.1007/s40121020-00305-6) contains supplementary material, which is available to authorized users. H. S. Kim K. Yang (&) Sanofi Pasteur, Seoul, Korea e-mail: [email protected] Y. Oh Sanofi Singapore, South Beach Tower, Singapore, Singapore J. Korejwo V. B. Castells Sanofi Pasteur, Lyon, France
(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 JECV 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 \ 24 months (34.7% [52/150] subjects; 107 events) and 2 to \ 10 years (17.8% [8/45] subjects; 14 events). All unsolicited adverse events (serious and non-serious) were unrelated to vaccination. There were no discontinuations due to adverse reactions/events. Conclusion: JE-CV has a good safety profile under practice conditions in South Korea. No new safety issues were identified. Trial registration: ClinicalTrials.gov identifier, NCT02933710 Keywords: Japanese encephalitis; Liveattenuated Japanese encephalitis chimeric virus vaccine; Safety; Vaccine
Infect Dis Ther
Key Summary Points Why carry out this study? A post-marketing surveillance study was undertaken to actively monitor the safety profile of the live attenuated Japanese encephalitis chimeric virus vaccine (JECV; ImojevÒ) following its introduction in South Korea as part
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