tetano
Editor, Senior Moderator
Infect Dis Ther
. 2022 Sep 7;1-9.
doi: 10.1007/s40121-022-00685-x. Online ahead of print.
Post-marketing Surveillance of a Quadrivalent Influenza Vaccine (Vaxigrip Tetra) in South Korea
Sookyung Lim[SUP] 1 [/SUP], Xiaoling Li[SUP] 2 [/SUP], Olga Syrkina[SUP] 3 [/SUP], Marion Fournier[SUP] 4 [/SUP]
Affiliations
Abstract
Introduction: In 2017, a quadrivalent inactivated split-virion influenza vaccine (QIV; Vaxigrip Tetra[SUP]®[/SUP], 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 participants or their legally acceptable representatives were instructed to record any adverse reactions (solicited events) and unsolicited non-serious adverse events (AE) in diary cards, and notify study investigators in case of serious adverse events (SAE).
Results: Overall, 663 participants were included in this study. There were no AEs leading to study termination, and no SAEs reported. Injection site pain (278 [41.9%]) was the most frequent solicited injection site reaction, with myalgia (250 [37.7%]) and malaise (236 [35.6%]) the most frequent solicited systemic reactions. Grade 3 solicited injection site and systemic reactions were reported by 8 (1.2%) and 13 (2.0%) participants, respectively; most participants with solicited reactions recovered without the need for further action. Overall, 39 (5.9%) participants experienced 49 unsolicited non-serious AEs with the most frequently reported being nasopharyngitis (19 [2.9%]). Grade 3 unsolicited non-serious adverse events were reported in 1 (0.2%) participant. None of the unsolicited non-serious AEs were considered to be related to QIV.
Conclusion: This post-marketing surveillance study confirms that QIV is well tolerated and has an acceptable safety profile in routine practice in South Korea. No unexpected safety concerns were identified.
Trial registration: ClinicalTrials.gov identifier NCT05406180.
Keywords: Influenza; Post-marketing surveillance study; Quadrivalent inactivated split-virion influenza vaccine; Safety; South Korea; Vaxigrip Tetra.
. 2022 Sep 7;1-9.
doi: 10.1007/s40121-022-00685-x. Online ahead of print.
Post-marketing Surveillance of a Quadrivalent Influenza Vaccine (Vaxigrip Tetra) in South Korea
Sookyung Lim[SUP] 1 [/SUP], Xiaoling Li[SUP] 2 [/SUP], Olga Syrkina[SUP] 3 [/SUP], Marion Fournier[SUP] 4 [/SUP]
Affiliations
- PMID: 36070176
- PMCID: PMC9450834
- DOI: 10.1007/s40121-022-00685-x
Abstract
Introduction: In 2017, a quadrivalent inactivated split-virion influenza vaccine (QIV; Vaxigrip Tetra[SUP]®[/SUP], 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 participants or their legally acceptable representatives were instructed to record any adverse reactions (solicited events) and unsolicited non-serious adverse events (AE) in diary cards, and notify study investigators in case of serious adverse events (SAE).
Results: Overall, 663 participants were included in this study. There were no AEs leading to study termination, and no SAEs reported. Injection site pain (278 [41.9%]) was the most frequent solicited injection site reaction, with myalgia (250 [37.7%]) and malaise (236 [35.6%]) the most frequent solicited systemic reactions. Grade 3 solicited injection site and systemic reactions were reported by 8 (1.2%) and 13 (2.0%) participants, respectively; most participants with solicited reactions recovered without the need for further action. Overall, 39 (5.9%) participants experienced 49 unsolicited non-serious AEs with the most frequently reported being nasopharyngitis (19 [2.9%]). Grade 3 unsolicited non-serious adverse events were reported in 1 (0.2%) participant. None of the unsolicited non-serious AEs were considered to be related to QIV.
Conclusion: This post-marketing surveillance study confirms that QIV is well tolerated and has an acceptable safety profile in routine practice in South Korea. No unexpected safety concerns were identified.
Trial registration: ClinicalTrials.gov identifier NCT05406180.
Keywords: Influenza; Post-marketing surveillance study; Quadrivalent inactivated split-virion influenza vaccine; Safety; South Korea; Vaxigrip Tetra.