title: Effectiveness of adjuvanted influenza vaccination in elderly subjects in northern Italy.
abstract: Although vaccination against influenza is recommended for elderly and high-risk patients in many countries, efficacy in the elderly has been suboptimal. The MF59 adjuvanted trivalent inactivated vaccine (ATIV) was developed to increase the immune response of elderly subjects to influenza vaccination, but its effectiveness has not yet been well documented. This prospective, observational study evaluated the relative effectiveness of ATIV versus nonadjuvanted trivalent inactivated vaccine (TIV) in individuals at least 65 years of age in Lombardy, northern Italy. Hospitalizations for influenza or pneumonia (International Classification of Diseases, Ninth Revision, Clinical Modification, codes 480-487) during the 2006-2007, 2007-2008, and 2008-2009 influenza seasons were identified from administrative databases. Stratified and regression analyses, including the propensity score to adjust for confounding, as well as generalized estimating equations to account for repeated vaccination, were used. Overall, 107,661 records were evaluated, contributing 170,988 person-seasons of observation. Since ATIV is preferentially recommended for more frail individuals, subjects vaccinated with ATIV were older and had more functional impairment and comorbidities. In the primary analysis, risk of hospitalization for influenza or pneumonia was 25% lower for ATIV relative to TIV (relative risk = 0.75, 95% confidence interval: 0.57, 0.98). To the extent that there is residual bias, ATIV is likely to be even more protective than this result suggests.
authors.affiliation: Azienda Sanitaria Locale della provincia di Cremona, Italy. salvatore.mannino@villasofia.it
authors.forename: Salvatore
authors.initials: S
authors.lastname: Mannino
authors.forename: Marco
authors.initials: M
authors.lastname: Villa
authors.forename: Giovanni
authors.initials: G
authors.lastname: Apolone
authors.forename: Noel S
authors.initials: NS
authors.lastname: Weiss
authors.forename: Nicola
authors.initials: N
authors.lastname: Groth
authors.forename: Ivana
authors.initials: I
authors.lastname: Aquino
authors.forename: Liana
authors.initials: L
authors.lastname: Boldori
authors.forename: Fausta
authors.initials: F
authors.lastname: Caramaschi
authors.forename: Antonio
authors.initials: A
authors.lastname: Gattinoni
authors.forename: Giancarlo
authors.initials: G
authors.lastname: Malchiodi
authors.forename: Kenneth J
authors.initials: KJ
authors.lastname: Rothman
mesh_terms: D000276:Adjuvants, Immunologic; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D015331:Cohort Studies; D005260:Female; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D007252:Influenza Vaccines / Q000737:chemistry*; D007251:Influenza, Human / Q000517:prevention & control*; D007558:Italy; D016015:Logistic Models; D008297:Male; D015999:Multivariate Analysis; D011136:Polysorbates; D057216:Propensity Score; D011446:Prospective Studies; D013185:Squalene; D015164:Vaccines, Inactivated / Q000737:chemistry
chemical_list: D000276:Adjuvants, Immunologic; D007252:Influenza Vaccines; C089950:MF59 oil emulsion; D011136:Polysorbates; D015164:Vaccines, Inactivated; D013185:Squalene