tetano
Editor, Senior Moderator
Vaccine
. 2026 Apr 17:82:128582.
doi: 10.1016/j.vaccine.2026.128582. Online ahead of print.
Immunogenicity and safety of recombinant influenza vaccine versus standard inactivated influenza vaccine in children aged 3 to 8 years: results from a phase III randomised study
Pedro M Folegatti[SUP] 1 [/SUP], Stephanie Pepin[SUP] 2 [/SUP], Cynthia Tabar[SUP] 2 [/SUP], Katherine Fries[SUP] 3 [/SUP], Oxana Talanova[SUP] 4 [/SUP], Stephanie See[SUP] 5 [/SUP], Kathleen Kaas-Leach[SUP] 3 [/SUP], Iris De Bruijn[SUP] 6 [/SUP]
Affiliations
Influenza vaccines for those aged <9 years old are limited to the standard-dose inactivated influenza vaccine (IIV) and live-attenuated intranasal influenza vaccine. In this Phase III, modified double-blind, active-controlled trial, participants aged 3-8 years were randomised in a 1:1 ratio to receive the quadrivalent recombinant influenza vaccine (RIV4) or quadrivalent inactivated influenza vaccine (IIV4). The non-inferiority of immune responses was assessed using geometric mean titre ratios (GMTRs) 28 days after the last vaccine administration and seroconversion rates (NCT05513391). A futility analysis was conducted after approximately 25% of the overall sample size was enrolled. Of the 1412 participants planned, 366 participants were enrolled in the United States, Poland, and Spain, resulting in a lower overall study power. The RIV4 induced non-inferior immune responses to those for IIV4 for the A/H1N1, A/H3N2, and B/Yamagata strains but not for the B/Victoria strain. Both vaccines were well tolerated with no safety concerns.
Keywords: Children; Immunogenicity; Influenza; Recombinant; Safety; Vaccination.
. 2026 Apr 17:82:128582.
doi: 10.1016/j.vaccine.2026.128582. Online ahead of print.
Immunogenicity and safety of recombinant influenza vaccine versus standard inactivated influenza vaccine in children aged 3 to 8 years: results from a phase III randomised study
Pedro M Folegatti[SUP] 1 [/SUP], Stephanie Pepin[SUP] 2 [/SUP], Cynthia Tabar[SUP] 2 [/SUP], Katherine Fries[SUP] 3 [/SUP], Oxana Talanova[SUP] 4 [/SUP], Stephanie See[SUP] 5 [/SUP], Kathleen Kaas-Leach[SUP] 3 [/SUP], Iris De Bruijn[SUP] 6 [/SUP]
Affiliations
- PMID: 42000149
- DOI: 10.1016/j.vaccine.2026.128582
Influenza vaccines for those aged <9 years old are limited to the standard-dose inactivated influenza vaccine (IIV) and live-attenuated intranasal influenza vaccine. In this Phase III, modified double-blind, active-controlled trial, participants aged 3-8 years were randomised in a 1:1 ratio to receive the quadrivalent recombinant influenza vaccine (RIV4) or quadrivalent inactivated influenza vaccine (IIV4). The non-inferiority of immune responses was assessed using geometric mean titre ratios (GMTRs) 28 days after the last vaccine administration and seroconversion rates (NCT05513391). A futility analysis was conducted after approximately 25% of the overall sample size was enrolled. Of the 1412 participants planned, 366 participants were enrolled in the United States, Poland, and Spain, resulting in a lower overall study power. The RIV4 induced non-inferior immune responses to those for IIV4 for the A/H1N1, A/H3N2, and B/Yamagata strains but not for the B/Victoria strain. Both vaccines were well tolerated with no safety concerns.
Keywords: Children; Immunogenicity; Influenza; Recombinant; Safety; Vaccination.