Safety and immunogenicity of an MF59™-adjuvanted subunit influenza vaccine in elderly Chinese subjects

Rongcheng Li¹ , Hanhua Fang² , Yanping Li¹ , Youping Liu³ , Michele Pellegrini⁴ and Audino Podda⁴

¹Centre for Vaccine Clinical Research, Centers for Disease Prevention and Control of Guangxi Zhuang Autonomous Region, 18 Jinzhou Street, 530022 Nanning City, China

²National Institute for the Control of Pharmaceutical and Biological Products (NICPBP), Temple of Heaven, Beijing, China

³Centers for Disease Prevention and Control of Wuzhou, Guangxi Zhuang Autonomous Region, China

⁴Clinical Research Development and Medical Affairs, Novartis Vaccines and Diagnostics, Siena, Italy

author email corresponding author email

Immunity & Ageing 2008, 5:2doi:10.1186/1742-4933-5-2


Published:	20 February 2008

Abstract

Background

The safety and immunogenicity of an MF59™-adjuvanted subunit influenza vaccine (Sub/MF59™; FLUAD^®, Novartis Vaccines) was evaluated among elderly Chinese subjects (≥ 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 ≤ 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).

Conclusion

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.

Clinical trial registry

http://www.clinicaltrials.gov webcite, NCT00310648