title: Comparison of the adverse events associated with MF59-adjuvanted and non-adjuvanted H1N1 vaccines in healthy young male Korean soldiers.
abstract: The first large-scale outbreaks of respiratory disease in the 21st century were  caused by the influenza A (H1N1) virus in 2009, which affected mostly young adults. The M59  vaccine was developed to control pandemic influenza A (H1N1). However, the complications  arising from the use of the non-adjuvanted and adjuvanted vaccines in young male Korean soldiers  have not previously been evaluated and compared. We conducted a prospective multicenter study  of 2,864 healthy male soldiers aged 19 to 25 years to evaluate the adverse events associated  with both the MF59-adjuvanted and non-adjuvanted forms of the influenza A/California/2009  (H1N1) surface-antigen vaccine. In most cases, the adverse-event symptoms were mild, and the  most frequent adverse events were swelling at the injection site and myalgia, which were noted  in 4.8% and 10.7% of participants, respectively. Administration of the MF59-adjuvanted vaccine  was associated with an increased incidence of local (crude odds ratio [cOR], 1.56; 95%  confidence interval [CI], 1.11-2.29) and systemic adverse events (cOR, 1.64; 95% CI, 1.29-2.07)  after vaccination. Atopic dermatitis (adjusted OR [aOR], 2.32; 95% CI, 0.99-5.46) might be the  choice risk factor for local adverse events, and adjuvant use (aOR, 1.35; 95% CI, 1.03-1.78)  was a significant predictor of systemic adverse events in healthy young male Korean soldiers.
authors.affiliation: Department of Preventive Medicine, Armed Forces Medical Command, Seongnam, Korea.
authors.forename: Se-Min
authors.initials: SM
authors.lastname: Hwang
authors.forename: Hack-Lyoung
authors.initials: HL
authors.lastname: Kim
authors.forename: Kyueng-Whan
authors.initials: KW
authors.lastname: Min
authors.forename: Min
authors.initials: M
authors.lastname: Kim
authors.forename: Jae-Sung
authors.initials: JS
authors.lastname: Lim
authors.forename: Jin-Man
authors.initials: JM
authors.lastname: Choi
authors.forename: Byung-Chul
authors.initials: BC
authors.lastname: Chun
authors.forename: Min-Jeong
authors.initials: MJ
authors.lastname: Kim
authors.forename: Sang-Min
authors.initials: SM
authors.lastname: Lee
authors.forename: Seung-Young
authors.initials: SY
authors.lastname: Kim
authors.forename: Han-Ho
authors.initials: HH
authors.lastname: Jeon
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage / Q000009:adverse effects*; D000328:Adult; D006801:Humans; D015994:Incidence; D053118:Influenza A Virus, H1N1 Subtype / Q000276:immunology*; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology; D007251:Influenza, Human / Q000276:immunology / Q000517:prevention & control* / Q000821:virology; D008297:Male; D008889:Military Personnel; D011136:Polysorbates / Q000008:administration & dosage / Q000009:adverse effects*; D011446:Prospective Studies; D056910:Republic of Korea; D013185:Squalene / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology; D016896:Treatment Outcome; D014611:Vaccination / Q000009:adverse effects; D055815:Young Adult
chemical_list: D000276:Adjuvants, Immunologic; D007252:Influenza Vaccines; C089950:MF59 oil emulsion; D011136:Polysorbates; D013185:Squalene