title: Safety and immunogenicity of an MF59-adjuvanted subunit influenza vaccine in elderly Chinese subjects.
abstract: BACKGROUND
  The safety and immunogenicity of an MF59-adjuvanted subunit influenza vaccine (Sub/MF59; FLUAD, Novartis Vaccines) was evaluated among elderly Chinese subjects (> or = 60 years of age). After a preliminary Phase I, open-label study (n = 25) to assess safety 1-14 days post-vaccination, a comparative observer-blind, randomised, controlled clinical trial (n = 600) was performed to assess safety and immunogenicity versus a non-adjuvanted subunit influenza vaccine (Subunit; Agrippal, Novartis Vaccines). Subjects were randomised (2:1) to receive Sub/MF59 or Subunit.
  
  
  RESULTS
  Both vaccines were well tolerated, with no vaccine-related serious adverse events reported during the Phase I trial. During the observer-blind study, local and systemic reactions were generally similar for both vaccines 1-22 days post-vaccination; however, injection-site induration was more frequent among the Subunit group (P < 0.05), and mild pain at the injection site and fever were more frequent among Sub/MF59 recipients (P < or = 0.005). Both vaccines induced a significant (P < 0.001) increase in geometric mean titres (GMTs) for the three strains tested, versus baseline; GMTs against A/H1N1, A/H3N2 and B were significantly higher in the Sub/MF59 group (P = 0.034, P < 0.001 and P = 0.005, respectively). GMT ratios against A/H1N1, A/H3N2 and B were also significantly higher in the Sub/MF59 group (P = 0.038, P < 0.001 and P = 0.006, respectively). Similarly, the percentage of subjects achieving seroprotection or seroconversion on Day 22 was greater for Sub/MF59 recipients, reaching significance for A/H3N2 (P < 0.001).
  
  
  CONCLUSIONS
  MF59-adjuvanted subunit influenza vaccine is well tolerated by elderly Chinese subjects and induces a higher level of immunogenicity than a non-adjuvanted subunit influenza vaccine in this population that is at high risk of influenza-related complications.
  
  
  BACKGROUND
  http://www.clinicaltrials.gov, NCT00310648.
authors.affiliation: Centre for Vaccine Clinical Research, Center for Disease Prevention, 18 Jinzhou Street, 530022 Nanning City, China. lrch2001@163.com
authors.forename: Rongcheng
authors.initials: R
authors.lastname: Li
authors.forename: Hanhua
authors.initials: H
authors.lastname: Fang
authors.forename: Yanping
authors.initials: Y
authors.lastname: Li
authors.forename: Youping
authors.initials: Y
authors.lastname: Liu
authors.forename: Michele
authors.initials: M
authors.lastname: Pellegrini
authors.forename: Audino
authors.initials: A
authors.lastname: Podda