Hwang K.-P.Hsu Y.-L.Hsieh T.-H.Lin H.-C.TING-YU YENWei H.-M.Lin H.-C.Chen A.-C.Chow J.C.LI-MIN HUANG2021-04-072021-04-0720140264-410Xhttps://www.scopus.com/inward/record.uri?eid=2-s2.0-84898428723&doi=10.1016%2fj.vaccine.2014.02.078&partnerID=40&md5=46f55a031b62c29690b95e8b3aeacda5https://scholars.lib.ntu.edu.tw/handle/123456789/556297This prospective study aimed to investigate the immune responses and safety of an influenza vaccine in vaccine-na?ve infants aged 6-12 months, and was conducted from November 2010 to May 2011. Fifty-nine infants aged 6-12 months received two doses of trivalent inactivated influenza vaccine 4 weeks apart. Hemagglutination inhibition titers were measured 4 weeks after the two doses of study vaccine. Based on the assumption that a hemagglutination inhibition titer of 1:40 or greater against the antigen would be protective in adults, two doses of the study vaccine generated a protective immune response of 63.2% against influenza A(H1N1), 82.5% against influenza A(H3N2) and 38.6% against influenza B viruses in infants aged 6-12 months. The geometric mean fold rises against influenza type A and B viruses also met the European Medicines Agency criteria for flu vaccines. The solicited events within 7 days after vaccination were mild in intensity. No deaths or adverse events such as optic neuritis, cranial neuropathy, and brachial neuropathy or Guillain-Barre syndrome were reported. Two doses of inactivated influenza vaccine were well tolerated and induced a protective immune response against influenza in infants aged 6-12 months. ? 2014 Elsevier Ltd.[SDGs]SDG3adimflu s; hemagglutination inhibiting antibody; inactivated virus vaccine; influenza vaccine; unclassified drug; antibody titer; article; brachialgia; bronchiolitis; chest tightness; coughing; cranial neuropathy; drug safety; drug tolerability; ecchymosis; eye redness; face edema; fever; Guillain Barre syndrome; headache; hemagglutination inhibition; human; immune response; immunogenicity; infant; influenza A (H1N1); influenza A (H3N2); influenza B; influenza vaccination; malaise; myalgia; nausea; nose obstruction; optic neuritis; pain; priority journal; respiratory distress; sore throat; swelling; Taiwan; urinary tract infection; vomiting; Children; Immunogenicity; Infant; Influenza; Influenza vaccine; Safety; Antibodies, Viral; Female; Hemagglutination Inhibition Tests; Humans; Infant; Influenza A Virus, H1N1 Subtype; Influenza A Virus, H3N2 Subtype; Influenza B virus; Influenza Vaccines; Influenza, Human; Male; Prospective Studies; Taiwan; Vaccines, Inactivatedjournal article10.1016/j.vaccine.2014.02.078246253412-s2.0-84898428723