Journal of Clinical Trials

Journal of Clinical Trials
Open Access

ISSN: 2167-0870

+44 7868 792050


Immunogenicity and Safety of an MF59®-Adjuvanted and a Non-Adjuvanted Inactivated Subunit Influenza Vaccine in Adults Affected by Chronic Diseases

Vincenzo Baldo, Tatjana Baldovin, Gabriele Angiolelli, Pantaleo Nacci, Michele Pellegrini, Derek O’Hagan, Nicola Groth and Family Medicine Group of Pianiga

Background: Influenza is a leading cause of morbidity and mortality in subjects with chronic diseases, who may also exhibit reduced immunogenicity to conventional influenza vaccines. MF59-adjuvanted influenza vaccine may enhance their immune response. Methods: We compared immunogenicity and safety of MF59-Adjuvanted Trivalent Influenza Vaccine (ATIV; Fluad®, Novartis Vaccines) and non-adjuvanted subunit (TIV; Agrippal®, Novartis Vaccines) in adults with at least one moderate to severe chronic condition. In this phase III, randomised, controlled, observer-blind study all subjects (18- 60 years of age) received one dose of ATIV (N=180) or TIV (N=179) vaccine during 2006/07 NH influenza season. Immunogenicity was tested using Hemagglutination Inhibition (HI) assay against vaccine and mismatched strains. Subjects were followed for safety for six months. Results: ATIV elicited significantly higher HI geometric mean titres (GMTs; P < .01) and mean-fold increases in titres (GMRs; P < .01) against all vaccine strains, compared with TIV. Seroprotection rates (HI ≥ 40) were 67–93% and 49–78% for ATIV and TIV groups, respectively (P < .01). ATIV also induced significantly higher GMTs against three mismatched strains (P < .05), and significantly greater GMRs against mismatched A strains (P < .05). Both influenza vaccines were well tolerated and safe, although ATIV elicited more solicited local and systemic (both 49%) reactions than TIV (both 28%). Most reactions (> 97%) were mild to moderate and all resolved spontaneously. Conclusion: ATIV is well tolerated, safe and confers higher and broader immunogenicity, when compared with a TIV, in adults with underlying chronic diseases.