Comparison of the adverse events associated with MF59-adjuvanted and non-adjuvanted H1N1 vaccines in healthy young male Korean soldiers.

Se Min Hwang, Hack Lyoung Kim, Kyueng Whan Min, Min Kim, Jae Sung Lim, Jin Man Choi, Byung Chul Chun, Min Jeong Kim, Sang Min Lee, Seung Young Kim, Han Ho Jeon

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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.

Original languageEnglish
Pages (from-to)193-197
Number of pages5
JournalJapanese journal of infectious diseases
Volume65
Issue number3
Publication statusPublished - 2012

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ASJC Scopus subject areas

  • Microbiology (medical)
  • Infectious Diseases

Cite this

Hwang, S. M., Kim, H. L., Min, K. W., Kim, M., Lim, J. S., Choi, J. M., Chun, B. C., Kim, M. J., Lee, S. M., Kim, S. Y., & Jeon, H. H. (2012). Comparison of the adverse events associated with MF59-adjuvanted and non-adjuvanted H1N1 vaccines in healthy young male Korean soldiers. Japanese journal of infectious diseases, 65(3), 193-197.