Post-Marketing Safety Surveillance of Quadrivalent Influenza Vaccine (VaxigripTetra) in Children Aged 6 to 35 Months in South Korea
© 2023. The Author(s)..
INTRODUCTION: The quadrivalent inactivated split-virion influenza vaccine (QIV; VaxigripTetra®) 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 ≤ 23-month (12.2% [55/450]) and ≥ 24-month (15.5% [35/226]) age groups. The most frequent solicited systemic reactions were pyrexia and somnolence in the ≤ 23-month age group (6.0% [27/450] each), and malaise (10.6% [24/226]) 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.
Medienart: |
E-Artikel |
---|
Erscheinungsjahr: |
2023 |
---|---|
Erschienen: |
2023 |
Enthalten in: |
Zur Gesamtaufnahme - volume:12 |
---|---|
Enthalten in: |
Infectious diseases and therapy - 12(2023), 6 vom: 10. Juni, Seite 1715-1723 |
Sprache: |
Englisch |
---|
Beteiligte Personen: |
Choe, Sunho [VerfasserIn] |
---|
Links: |
---|
Themen: |
Children |
---|
Anmerkungen: |
Date Revised 21.06.2023 published: Print-Electronic Citation Status PubMed-not-MEDLINE |
---|
doi: |
10.1007/s40121-023-00825-x |
---|
funding: |
|
---|---|
Förderinstitution / Projekttitel: |
|
PPN (Katalog-ID): |
NLM358024854 |
---|
LEADER | 01000naa a22002652 4500 | ||
---|---|---|---|
001 | NLM358024854 | ||
003 | DE-627 | ||
005 | 20231226073848.0 | ||
007 | cr uuu---uuuuu | ||
008 | 231226s2023 xx |||||o 00| ||eng c | ||
024 | 7 | |a 10.1007/s40121-023-00825-x |2 doi | |
028 | 5 | 2 | |a pubmed24n1193.xml |
035 | |a (DE-627)NLM358024854 | ||
035 | |a (NLM)37300743 | ||
040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
041 | |a eng | ||
100 | 1 | |a Choe, Sunho |e verfasserin |4 aut | |
245 | 1 | 0 | |a Post-Marketing Safety Surveillance of Quadrivalent Influenza Vaccine (VaxigripTetra) in Children Aged 6 to 35 Months in South Korea |
264 | 1 | |c 2023 | |
336 | |a Text |b txt |2 rdacontent | ||
337 | |a ƒaComputermedien |b c |2 rdamedia | ||
338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
500 | |a Date Revised 21.06.2023 | ||
500 | |a published: Print-Electronic | ||
500 | |a Citation Status PubMed-not-MEDLINE | ||
520 | |a © 2023. The Author(s). | ||
520 | |a INTRODUCTION: The quadrivalent inactivated split-virion influenza vaccine (QIV; VaxigripTetra®) 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 | ||
520 | |a 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 | ||
520 | |a 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 ≤ 23-month (12.2% [55/450]) and ≥ 24-month (15.5% [35/226]) age groups. The most frequent solicited systemic reactions were pyrexia and somnolence in the ≤ 23-month age group (6.0% [27/450] each), and malaise (10.6% [24/226]) 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 | ||
520 | |a 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 | ||
650 | 4 | |a Journal Article | |
650 | 4 | |a Children | |
650 | 4 | |a Influenza | |
650 | 4 | |a Post-marketing surveillance study | |
650 | 4 | |a Quadrivalent inactivated split-virion influenza vaccine | |
650 | 4 | |a Safety | |
650 | 4 | |a South Korea | |
650 | 4 | |a VaxigripTetra | |
700 | 1 | |a Talanova, Oxana |e verfasserin |4 aut | |
700 | 1 | |a Shin, Sooyoun |e verfasserin |4 aut | |
700 | 1 | |a Syrkina, Olga |e verfasserin |4 aut | |
700 | 1 | |a Fournier, Marion |e verfasserin |4 aut | |
773 | 0 | 8 | |i Enthalten in |t Infectious diseases and therapy |d 2012 |g 12(2023), 6 vom: 10. Juni, Seite 1715-1723 |w (DE-627)NLM240483693 |x 2193-8229 |7 nnns |
773 | 1 | 8 | |g volume:12 |g year:2023 |g number:6 |g day:10 |g month:06 |g pages:1715-1723 |
856 | 4 | 0 | |u http://dx.doi.org/10.1007/s40121-023-00825-x |3 Volltext |
912 | |a GBV_USEFLAG_A | ||
912 | |a GBV_NLM | ||
951 | |a AR | ||
952 | |d 12 |j 2023 |e 6 |b 10 |c 06 |h 1715-1723 |