Pavia-Ruz N.Weber M.A.R.Lau Y.-L.Nelson E.A.S.Kerdpanich A.LI-MIN HUANGSilas P.Qaqundah P.Blatter M.Jeanfreau R.Lei P.Jain V.El Idrissi M.Feng Y.Innis B.Peeters M.Devaster J.-M.2021-06-242021-06-2420132164-5515https://www.scopus.com/inward/record.uri?eid=2-s2.0-84884640989&doi=10.4161%2fhv.25363&partnerID=40&md5=b4f34f6a06c5c9d0c52fba77732d6694https://scholars.lib.ntu.edu.tw/handle/123456789/566455The trivalent inactivated influenza vaccine Fluarix? is licensed in the US for adults and children from 3 years old. This randomized observer-blind study (NCT00764790) evaluated Fluarix? at two doses; 0.25 ml (Flu-25) and 0.5 ml (Flu-50) in children aged 6-35 months. The primary objective was to demonstrate immunogenic non-inferiority vs. a control vaccine (Fluzone?; 0.25 ml). Children received Flu-25 (n = 1107), Flu-50 (n = 1106) or control vaccine (n = 1104) at Day 0 and for unprimed children, also on Day 28. Serum hemagglutination-inhibition titers were determined pre-vaccination and at Day 28 (primed) or Day 56 (un-primed). Non-inferiority was assessed by post-vaccination geometric mean titer (GMT) ratio, (upper 95% confidence interval [CI] ? 1.5) and difference in seroconversion rate (upper 95% CI ? 10%). Reactogenicity/ safety was monitored. The immune response to Flu-50 met all regulatory criteria. Indicated by adjusted GMT ratios [with 95% CI], the criteria for non-inferiority of Flu-50 vs. control vaccine were reached for the B/Florida strain (1.13 [1.01-1.25]) but not for the A/Brisbane/H1N1 (1.74 [1.54-1.98]) or A/Uruguay/H3N2 (1.72 [1.57-1.89]) strains. In children aged 18-35 months similar immune responses were observed for Flu-50 and the control vaccine. Flu-50 induced a higher response than Flu-25 for all strains. Temperature (?37.5°C) was reported in 6.2%, 6.4%, and 6.6% of the Flu-25, Flu-50, and control group, respectively. Reactogenicity/safety endpoints were within the same range for all vaccines. In children aged 6-35 months, immune responses with Flu-50 fulfilled regulatory criteria but did not meet the predefined criteria for non-inferiority vs. control. This appeared to be due to differences in immunogenicity in children aged <18 months. ? 2013 Landes Bioscience.Children; Immunogenicity; Influenza; Trivalent inactivated; Vaccine[SDGs]SDG3influenza vaccine; allergic rhinitis; anemia; apnea; article; asthma; bronchiolitis; child; child health care; chronic disease; clinical effectiveness; clinical evaluation; controlled study; cyanosis; dose response; drowsiness; drug dose comparison; drug efficacy; drug safety; female; fever; gastroenteritis; hemagglutination inhibition; human; immune response; immunogenicity; infant; infection prevention; influenza vaccination; injection site pain; injection site swelling; irritability; loss of appetite; male; pneumonia; preschool child; randomized controlled trial; seasonal influenza; seroconversion; side effect; skin redness; treatment outcome; upper respiratory tract infection; children; immunogenicity; influenza; trivalent inactivated; vaccine; Antibodies, Viral; Child, Preschool; Drug-Related Side Effects and Adverse Reactions; Female; Hemagglutination Inhibition Tests; Humans; Infant; Influenza Vaccines; Influenza, Human; Male; Vaccination; Vaccines, Inactivatedjournal article10.4161/hv.25363237829622-s2.0-84884640989