PMID- 37300743 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20230621 IS - 2193-8229 (Print) IS - 2193-6382 (Electronic) IS - 2193-6382 (Linking) VI - 12 IP - 6 DP - 2023 Jun TI - Post-Marketing Safety Surveillance of Quadrivalent Influenza Vaccine (VaxigripTetra) in Children Aged 6 to 35 Months in South Korea. PG - 1715-1723 LID - 10.1007/s40121-023-00825-x [doi] AB - INTRODUCTION: The quadrivalent inactivated split-virion influenza vaccine (QIV; VaxigripTetra((R))) was initially licensed in South Korea in 2017 for immunization against seasonal influenza in those aged >/= 3 years, with the indicated age subsequently lowered to include those aged >/= 6 months in 2018. Here, to comply with South Korean licensure requirements, we undertook a post-marketing surveillance study to assess the safety of QIV in children aged 6-35 months (i.e., extension of the previous age indication to include these young children) in routine clinical practice. METHODS: A multicenter, observational, active safety surveillance of children aged 6-35 months who received a single dose of QIV during a routine healthcare visit was undertaken in South Korea from 15 June 2018 to 14 June 2022. Solicited adverse events (AEs) and unsolicited non-serious AEs were recorded in diary cards, with serious adverse events (SAEs) notified to study investigators. RESULTS: This safety analysis included 676 participants. No AEs led to study termination, and no SAEs were reported. The most frequent solicited injection site reaction was pain in both the /= 24-month (15.5% [35/226]) age groups. The most frequent solicited systemic reactions were pyrexia and somnolence in the /= 24-month age group. Overall, 208 (30.8%) participants experienced 339 unsolicited non-serious AEs, with nasopharyngitis the most common (14.1% [95/676]), and nearly all events (98.8% [335/339]) were considered unrelated to QIV. Grade 3 solicited reactions and unsolicited non-serious AEs were reported in five (0.7%) and three (0.4%) participants, respectively, all of whom recovered by day 7 after vaccination. CONCLUSION: This active safety surveillance study confirms that QIV is well tolerated in children aged 6-35 months in routine clinical practice in South Korea. There were no safety concerns observed in these young children. CI - (c) 2023. The Author(s). FAU - Choe, Sunho AU - Choe S AUID- ORCID: 0000-0002-9460-8636 AD - Sanofi, 235 Banpo-daero, Seocho-Gu, Seoul, 06578, South Korea. sunho.choe@sanofi.com. FAU - Talanova, Oxana AU - Talanova O AD - Sanofi, Lyon, France. FAU - Shin, Sooyoun AU - Shin S AD - Sanofi, 235 Banpo-daero, Seocho-Gu, Seoul, 06578, South Korea. FAU - Syrkina, Olga AU - Syrkina O AD - Sanofi, Swiftwater, PA, USA. FAU - Fournier, Marion AU - Fournier M AD - Sanofi, Lyon, France. LA - eng PT - Journal Article DEP - 20230610 PL - New Zealand TA - Infect Dis Ther JT - Infectious diseases and therapy JID - 101634499 PMC - PMC10257373 OTO - NOTNLM OT - Children OT - Influenza OT - Post-marketing surveillance study OT - Quadrivalent inactivated split-virion influenza vaccine OT - Safety OT - South Korea OT - VaxigripTetra COIS- All named authors are employees of Sanofi and may hold shares and/or stock options in the company. EDAT- 2023/06/10 23:42 MHDA- 2023/06/10 23:43 PMCR- 2023/06/10 CRDT- 2023/06/10 11:15 PHST- 2023/04/14 00:00 [received] PHST- 2023/05/18 00:00 [accepted] PHST- 2023/06/10 23:43 [medline] PHST- 2023/06/10 23:42 [pubmed] PHST- 2023/06/10 11:15 [entrez] PHST- 2023/06/10 00:00 [pmc-release] AID - 10.1007/s40121-023-00825-x [pii] AID - 825 [pii] AID - 10.1007/s40121-023-00825-x [doi] PST - ppublish SO - Infect Dis Ther. 2023 Jun;12(6):1715-1723. doi: 10.1007/s40121-023-00825-x. Epub 2023 Jun 10.