tetano
Editor, Senior Moderator
Int J Infect Dis. 2019 Apr 30. pii: S1201-9712(19)30194-8. doi: 10.1016/j.ijid.2019.04.023. [Epub ahead of print]
[h=1]MF59-Adjuvanted Seasonal Trivalent Inactivated Influenza Vaccine: Safety and Immunogenicity in Young Children at Risk of Influenza Complications.[/h] Patel SS[SUP]1[/SUP], Bizjajeva S[SUP]2[/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 assess safety and immunogenicity of the MF59[SUP]?[/SUP]-adjuvanted seasonal trivalent inactivated influenza vaccine (aIIV3; Fluad?) in children aged 6 months through 5 years who are at risk of influenza complications.
[h=4]METHODS:[/h] A retrospective analysis was performed to examine unsolicited adverse events (AEs) in an integrated data set from 6 randomized clinical studies that compared aIIV3 with nonadjuvanted inactivated influenza vaccines (IIV3). The integrated safety set comprised of 10,784 children, of which 373 (3%) were at risk of influenza complications.
[h=4]RESULTS:[/h] The at-risk safety population comprised 373 children 6 months through 5 years of age: 179 received aIIV3 and 194 received nonadjuvanted IIV3 (128 subjects received a licensed IIV3). The most important risk factors were include respiratory system illnesses (62% to 70%), or infectious and parasitic diseases (33% to 39%). During the treatment period, unsolicited AEs occurred in 54% of at-risk children and 55% of healthy children who received aIIV3; of those receiving licensed IIV3, 59% of at-risk and 62% of healthy subjects reported an unsolicited AE. The most common AEs were infections, including upper respiratory tract infection. Serious AEs (SAEs) were reported in <10% of at-risk subjects, and no vaccine-related SAEs were observed. In the immunogenicity subset (involving 103 participants from 1 study), geometric mean titers (GMTs) were approximately 2- to 3-fold higher with aIIV3 than with IIV3 for all 3 homologous strains (A/H1N1, A/H3N2, and B). Seroconversion rates were high for both aIIV3 (79% to 96%) and IIV3 (83% to 89%).
[h=4]CONCLUSION:[/h] In young children at risk of influenza complications, aIIV3 was well-tolerated and had a safety profile that was generally similar to that of nonadjuvanted IIV3. Similar to the not-at risk population, the immune response in at-risk subjects receiving aIIV3 was increased over those receiving IIV3, suggesting aIIV3 is a valuable option in young children at risk of influenza complications.
Copyright ? 2019. Published by Elsevier Ltd.
[h=4]KEYWORDS:[/h] MF59; adjuvant; children; influenza; risk of influenza complications; vaccine
PMID: 31051279 DOI: 10.1016/j.ijid.2019.04.023
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[h=1]MF59-Adjuvanted Seasonal Trivalent Inactivated Influenza Vaccine: Safety and Immunogenicity in Young Children at Risk of Influenza Complications.[/h] Patel SS[SUP]1[/SUP], Bizjajeva S[SUP]2[/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 assess safety and immunogenicity of the MF59[SUP]?[/SUP]-adjuvanted seasonal trivalent inactivated influenza vaccine (aIIV3; Fluad?) in children aged 6 months through 5 years who are at risk of influenza complications.
[h=4]METHODS:[/h] A retrospective analysis was performed to examine unsolicited adverse events (AEs) in an integrated data set from 6 randomized clinical studies that compared aIIV3 with nonadjuvanted inactivated influenza vaccines (IIV3). The integrated safety set comprised of 10,784 children, of which 373 (3%) were at risk of influenza complications.
[h=4]RESULTS:[/h] The at-risk safety population comprised 373 children 6 months through 5 years of age: 179 received aIIV3 and 194 received nonadjuvanted IIV3 (128 subjects received a licensed IIV3). The most important risk factors were include respiratory system illnesses (62% to 70%), or infectious and parasitic diseases (33% to 39%). During the treatment period, unsolicited AEs occurred in 54% of at-risk children and 55% of healthy children who received aIIV3; of those receiving licensed IIV3, 59% of at-risk and 62% of healthy subjects reported an unsolicited AE. The most common AEs were infections, including upper respiratory tract infection. Serious AEs (SAEs) were reported in <10% of at-risk subjects, and no vaccine-related SAEs were observed. In the immunogenicity subset (involving 103 participants from 1 study), geometric mean titers (GMTs) were approximately 2- to 3-fold higher with aIIV3 than with IIV3 for all 3 homologous strains (A/H1N1, A/H3N2, and B). Seroconversion rates were high for both aIIV3 (79% to 96%) and IIV3 (83% to 89%).
[h=4]CONCLUSION:[/h] In young children at risk of influenza complications, aIIV3 was well-tolerated and had a safety profile that was generally similar to that of nonadjuvanted IIV3. Similar to the not-at risk population, the immune response in at-risk subjects receiving aIIV3 was increased over those receiving IIV3, suggesting aIIV3 is a valuable option in young children at risk of influenza complications.
Copyright ? 2019. Published by Elsevier Ltd.
[h=4]KEYWORDS:[/h] MF59; adjuvant; children; influenza; risk of influenza complications; vaccine
PMID: 31051279 DOI: 10.1016/j.ijid.2019.04.023
Free full text