tetano
Editor, Senior Moderator
Int J Infect Dis. 2019 May 13. pii: S1201-9712(19)30215-2. doi: 10.1016/j.ijid.2019.05.009. [Epub ahead of print]
[h=1]Cumulative Clinical Experience with MF59-Adjuvanted Trivalent Seasonal Influenza Vaccine in Young Children.[/h] Patel SS[SUP]1[/SUP], Bizjajeva S[SUP]2[/SUP], Lindert K[SUP]1[/SUP], Heijnen E[SUP]3[/SUP], Oberye J[SUP]4[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]OBJECTIVE:[/h] To demonstrate the potential of an MF59-adjuvanted inactivated trivalent seasonal influenza vaccine (aIIV3; Fluad?), to improve the immune response in young children, we review the immunogenicity, efficacy, and safety/tolerability of aIIV3 from a comprehensive clinical development program in a pediatric population with a specific need for improved influenza vaccines.
[h=4]METHODS:[/h] Data were analyzed from a series of 1 phase 1b, 3 phase ii, and 2 phase III studies involving 11,942 children aged 6 months through 5 years.
[h=4]RESULTS:[/h] The clinical data showed that aIIV3 had statistically significantly greater immunogenicity and efficacy in the prevention of influenza compared to conventional inactivated trivalent seasonal influenza vaccines (IIV3s). The safety profile of aIIV3 was generally similar to that of nonadjuvanted IIV3, apart from an increased frequency of solicited adverse events (AEs) following vaccination. The majority of solicited AEs were mild or moderate in severity and resolved within 1 to 2 days.
[h=4]CONCLUSIONS:[/h] aIIV3 was well tolerated, with immunogenicity and efficacy exceeding that of conventional IIV3 in children 6 months through 5 years of age. The MF59-adjuvanted vaccine has the potential to fulfill an unmet clinical need in the prevention of seasonal influenza in this age group.
Copyright ? 2019. Published by Elsevier Ltd.
[h=4]KEYWORDS:[/h] MF59; adjuvant; children; influenza; vaccine
PMID: 31096055 DOI: 10.1016/j.ijid.2019.05.009
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[h=1]Cumulative Clinical Experience with MF59-Adjuvanted Trivalent Seasonal Influenza Vaccine in Young Children.[/h] Patel SS[SUP]1[/SUP], Bizjajeva S[SUP]2[/SUP], Lindert K[SUP]1[/SUP], Heijnen E[SUP]3[/SUP], Oberye J[SUP]4[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]OBJECTIVE:[/h] To demonstrate the potential of an MF59-adjuvanted inactivated trivalent seasonal influenza vaccine (aIIV3; Fluad?), to improve the immune response in young children, we review the immunogenicity, efficacy, and safety/tolerability of aIIV3 from a comprehensive clinical development program in a pediatric population with a specific need for improved influenza vaccines.
[h=4]METHODS:[/h] Data were analyzed from a series of 1 phase 1b, 3 phase ii, and 2 phase III studies involving 11,942 children aged 6 months through 5 years.
[h=4]RESULTS:[/h] The clinical data showed that aIIV3 had statistically significantly greater immunogenicity and efficacy in the prevention of influenza compared to conventional inactivated trivalent seasonal influenza vaccines (IIV3s). The safety profile of aIIV3 was generally similar to that of nonadjuvanted IIV3, apart from an increased frequency of solicited adverse events (AEs) following vaccination. The majority of solicited AEs were mild or moderate in severity and resolved within 1 to 2 days.
[h=4]CONCLUSIONS:[/h] aIIV3 was well tolerated, with immunogenicity and efficacy exceeding that of conventional IIV3 in children 6 months through 5 years of age. The MF59-adjuvanted vaccine has the potential to fulfill an unmet clinical need in the prevention of seasonal influenza in this age group.
Copyright ? 2019. Published by Elsevier Ltd.
[h=4]KEYWORDS:[/h] MF59; adjuvant; children; influenza; vaccine
PMID: 31096055 DOI: 10.1016/j.ijid.2019.05.009
Free full text