title: Immunogenicity and safety of a trivalent inactivated 2010-2011 influenza vaccine in Taiwan infants aged 6-12 months.
abstract: This prospective study aimed to investigate the immune responses and safety of an influenza vaccine in vaccine-naïve 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.
authors.affiliation: Division of Pediatric Infectious Diseases, Department of Pediatrics, China Medical University Hospital, Taichung, Taiwan; School of Medicine, China Medical University, Taichung, Taiwan. Electronic address: kapihw@mail.cmuh.org.tw.
authors.forename: Kao-Pin
authors.initials: KP
authors.lastname: Hwang
authors.affiliation: Division of Pediatric Infectious Diseases, Department of Pediatrics, China Medical University Hospital, Taichung, Taiwan.
authors.forename: Yu-Lung
authors.initials: YL
authors.lastname: Hsu
authors.affiliation: Division of Pediatric Infectious Diseases, Department of Pediatrics, China Medical University Hospital, Taichung, Taiwan.
authors.forename: Tsung-Hsueh
authors.initials: TH
authors.lastname: Hsieh
authors.affiliation: Division of Pediatric Infectious Diseases, Department of Pediatrics, China Medical University Hospital, Taichung, Taiwan.
authors.forename: Hsiao-Chuan
authors.initials: HC
authors.lastname: Lin
authors.affiliation: Division of Pediatric Infectious Diseases, Department of Pediatrics, China Medical University Hospital, Taichung, Taiwan.
authors.forename: Ting-Yu
authors.initials: TY
authors.lastname: Yen
authors.affiliation: Division of Pediatric Infectious Diseases, Department of Pediatrics, China Medical University Hospital, Taichung, Taiwan.
authors.forename: Hsiu-Mei
authors.initials: HM
authors.lastname: Wei
authors.affiliation: Division of Neonatology, Department of Pediatrics, China Medical University Hospital, Taichung, Taiwan.
authors.forename: Hung-Chih
authors.initials: HC
authors.lastname: Lin
authors.affiliation: Department of Pediatrics, China Medical University Hospital, Taichung, Taiwan.
authors.forename: An-Chyi
authors.initials: AC
authors.lastname: Chen
authors.affiliation: Department of Pediatric, Chi Mei Medical Center, Tainan, Taiwan.
authors.forename: Julie Chi
authors.initials: JC
authors.lastname: Chow
authors.affiliation: Department of Pediatrics, National Taiwan University Hospital Medical College, National Taiwan University, Taipei, Taiwan.
authors.forename: Li-Min
authors.initials: LM
authors.lastname: Huang
mesh_terms: D000914:Antibodies, Viral / Q000097:blood; D005260:Female; D006385:Hemagglutination Inhibition Tests; D006801:Humans; D007223:Infant; D053118:Influenza A Virus, H1N1 Subtype; D053122:Influenza A Virus, H3N2 Subtype; D009981:Influenza B virus; D007252:Influenza Vaccines / Q000009:adverse effects / Q000627:therapeutic use*; D007251:Influenza, Human / Q000517:prevention & control*; D008297:Male; D011446:Prospective Studies; D013624:Taiwan; D015164:Vaccines, Inactivated / Q000009:adverse effects / Q000627:therapeutic use
chemical_list: D000914:Antibodies, Viral; D007252:Influenza Vaccines; D015164:Vaccines, Inactivated
keywords: Children; Immunogenicity; Infant; Influenza; Influenza vaccine; Safety