MF59-adjuvanted versus non-adjuvanted influenza vaccines: Integrated analysis from a large safety database |
| |
Authors: | Michele Pellegrini Uwe Nicolay Kelly Lindert Nicola Groth Giovanni Della Cioppa |
| |
Affiliation: | 1. Global Clinical Research & Development, Novartis Vaccines and Diagnostics, Via Fiorentina 1, 53100 Siena, Italy;2. Global Clinical Research & Development, Novartis Vaccines and Diagnostics, Marburg, Germany;3. Global Clinical Research & Development, Novartis Vaccines and Diagnostics, Cambridge, MA, USA |
| |
Abstract: | BackgroundAdding adjuvants such as MF59® to influenza vaccines can enhance the immune response. This analysis evaluated the safety profile of MF59-adjuvanted [(+)MF59] compared with non-adjuvanted [(−)MF59] vaccines in a large clinical database.MethodsSafety data were pooled from 64 clinical trials involving (+)MF59 seasonal and pandemic influenza vaccines. Safety outcomes were analysed in the overall population and in subjects aged ≥65 years, in all clinical trials and in controlled trials only.FindingsData from 20,447 (+)MF59 and 7526 (−)MF59 subjects were analysed. Overall, (+)MF59 subjects had lower risks than (−)MF59 subjects of experiencing any unsolicited adverse event (AE) (26.8% vs 39.2%; adjusted risk ratio [ARR] 0.65; 95% CI 0.60–0.70), cardiovascular AEs (1.9% vs 5.6%; ARR 0.44; 95% CI 0.35–0.55), new onset chronic diseases (1.3% vs 1.9%; ARR 0.71; 95% CI 0.57–0.87) and death (0.8% vs 1.2%; ARR 0.67; 95% CI 0.51–0.87). Few AEs of potential autoimmune origin were reported: 0.71 and 0.67 per 1000 with (+)MF59 and (−)MF59, respectively. As expected, (+)MF59 subjects had a higher risk of solicited local or systemic reactions within 3 days of vaccination (58.5% vs 46.9%, weighted RR 1.34; 95% CI 1.28–1.40). Safety outcomes were consistent between total and elderly populations, and between all trials and controlled trials, although statistical significance was lost for some of the outcomes in the subgroups.InterpretationThis large-scale analysis supports the good safety profile of (+)MF59 seasonal and pandemic influenza vaccines and suggests a clinical benefit over (−)MF59 influenza vaccines. |
| |
Keywords: | Influenza vaccine Adjuvant Safety Autoimmune disease |
本文献已被 ScienceDirect 等数据库收录! |
|