Abstract
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 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.
Highlights
Influenza is a leading cause of morbidity and mortality in subjects with chronic diseases, who may exhibit reduced immunogenicity to conventional influenza vaccines
Our study aimed to evaluate the immunogenicity, clinical tolerability and safety of MF59-adjuvanted and non-adjuvanted trivalent inactivated subunit influenza vaccines in adult subjects with underlying chronic diseases
A total of 330 subjects were planned to be randomised in a 1:1 ratio according to a computer generated randomisation list supplied by the study sponsor to receive a single intramuscular (IM) 0.5 mL dose either of a subunit vaccine adjuvanted with MF59 (Fluad®, Novartis Vaccines [Adjuvanted Trivalent Influenza Vaccine (ATIV)]) or of a conventional subunit vaccine (Agrippal®, Novartis Vaccines [TIV])
Summary
Influenza is a leading cause of morbidity and mortality in subjects with chronic diseases, who may exhibit reduced immunogenicity to conventional influenza vaccines. MF59-adjuvanted influenza vaccine may enhance their immune response. Influenza infection causes a cascade of inflammatory response and can exacerbate underlying disease conditions, including Cardiovascular Disease (CVD) and diabetes, and can lead to viral pneumonia, or a co-infection with other viruses or bacteria [4]. Epidemiological data indicates that risk for complications, hospitalization and death from influenza is higher for adults with chronic conditions including CVD. Immunization is considered the best way of preventing influenza infection and its related complications. The increased risk of influenza related complications in adults with compromised immune systems makes it imperative to provide better prophylactic options and improve efforts for prevention
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