title: [Study on the safety and immunogenicity of MF59-adjuvanted influenza subunit vaccine in Chinese elderly].
abstract: OBJECTIVE
  To compare the safety and immunogenicity between a MF59-adjuvanted influenza subunit vaccine and a conventional non-adjuvanted influenza subunit vaccine.
  
  
  METHODS
  A randomized, blind-designed controlled study was carried out, with 600 subjects (> or = 60 years of age) received MF59-adjuvanted influenza subunit vaccine (FLUAD, n = 400) or conventional non-adjuvanted influenza subunit vaccine (Agrippal, n = 200) respectively. The local and systemic reactions were observed on 0-7 days after vaccination. Haemagglutination inhibition (HI) titers of pre-and post-vaccination were detected by the HI assay. Seroconversion (4-fold increase) rate of subjects was calculated using baseline data when it was under naive level, and the protection rate when HI titer achieving the level of protection (> or = 1:40) after vaccination. Geometric mean titer (GMT) and its increasing folds were calculated. Differences between safety and immunogenicity were also calculated.
  
  
  RESULTS
  The local and systemic reaction rates were similar between both groups, but the duration in injection site was frequent for Agrippal (P < 0.05), while mild pain and fever in injection site were frequent for FLUAD. On immunogenicity test, for those subjects whose baseline was under naive level while the seroconversion rate against A/H3N2 viral strain after vaccination--FLUAD was significantly higher than Agrippal (P < 0.001). Aside from A/H1N1 viral strain, the rate of protection on both groups were significantly higher than those from baseline data, but for A/H3N2 viral strain, FLUAD was significantly higher than Agrippal (P < 0.001). GMT was higher than baseline (P < 0.001) after both groups being vaccinated but FLUAD group was significantly higher than Agrippal group.
  
  
  CONCLUSIONS
  FLUAD was well tolerated by Chinese elderly and its immunogenicity level induced by FLUAD was higher than that of Agrippal, showing that it would benefit the elderly with hypoimmunity.
authors.affiliation: Vaccine Clinical Trial Center, Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention, Nanning 530028, China.
authors.forename: Rong-Cheng
authors.initials: RC
authors.lastname: Li
authors.forename: Han-Hua
authors.initials: HH
authors.lastname: Fang
authors.forename: Yan-Ping
authors.initials: YP
authors.lastname: Li
authors.forename: You-Ping
authors.initials: YP
authors.lastname: Liu
authors.forename: Yi
authors.initials: Y
authors.lastname: Nong
authors.forename: Gui-Biao
authors.initials: GB
authors.lastname: Huang
mesh_terms: D000276:Adjuvants, Immunologic; D006801:Humans; D007252:Influenza Vaccines / Q000009:adverse effects / Q000276:immunology*; D007251:Influenza, Human / Q000517:prevention & control*; D008875:Middle Aged; D011136:Polysorbates / Q000009:adverse effects; D016037:Single-Blind Method; D013185:Squalene / Q000009:adverse effects / Q000276:immunology*; D014612:Vaccines / Q000009:adverse effects / Q000276:immunology
chemical_list: D000276:Adjuvants, Immunologic; D007252:Influenza Vaccines; C089950:MF59 oil emulsion; D011136:Polysorbates; D014612:Vaccines; C478243:fluad vaccine; D013185:Squalene