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 simil

SUBMITTER: Li R 

PROVIDER: S-EPMC2291031 | biostudies-literature | 2008 Feb

REPOSITORIES: biostudies-literature