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Comparative Study
. 2013 Oct 1;178(7):1139-45.
doi: 10.1093/aje/kwt078. Epub 2013 Jul 17.

Safety of MF59-adjuvanted influenza vaccination in the elderly: results of a comparative study of MF59-adjuvanted vaccine versus nonadjuvanted influenza vaccine in northern Italy

Marco Villa, Steven Black, Nicola Groth, Kenneth J Rothman, Giovanni Apolone, Noel S Weiss, Ivana Aquino, Liana Boldori, Fausta Caramaschi, Antonio Gattinoni, Giancarlo Malchiodi, Antonio Crucitti, Giovanni Della Cioppa, Elio Scarpini, Domenico Mavilio, Salvatore Mannino
Comparative Study

Safety of MF59-adjuvanted influenza vaccination in the elderly: results of a comparative study of MF59-adjuvanted vaccine versus nonadjuvanted influenza vaccine in northern Italy

Marco Villa et al. Am J Epidemiol. .

Abstract

MF59-adjuvanted trivalent influenza vaccine (Novartis Vaccines and Diagnostics, Siena, Italy) has been shown to be more effective than nonadjuvanted vaccine in the elderly population. Here we present results from a large-scale, observational, noninterventional, prospective postlicensure study that evaluated the safety of MF59-adjuvanted vaccine in elderly subjects aged 65 years or more. The study was performed in 5 northern Italian health districts during the 2006-2007, 2007-2008, and 2008-2009 influenza seasons. The choice of vaccine-either adjuvanted vaccine or a nonadjuvanted influenza vaccine-was determined by individual providers on the basis of local influenza vaccination policy. Hospitalizations for potential adverse events of special interest (AESIs) were identified from hospital databases and then reviewed against recognized case definitions to identify confirmed cases of AESI. Cumulative incidences were calculated for AESIs in predefined biologically plausible time windows, as well as in a 6-month window following vaccination. During the 3-year study period, 170,988 vaccine doses were administered to a total of 107,661 persons. Despite the large study size, cases of AESI resulting in hospitalization were rare, and risks of AESI were similar in both the MF59-adjuvanted and nonadjuvanted vaccination groups. In conclusion, similar safety profiles were observed for both nonadjuvanted and MF59-adjuvanted seasonal influenza vaccines in elderly recipients.

Keywords: MF59; adjuvants; elderly; influenza; influenza vaccine; vaccine safety; vaccines.

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References

    1. Initiative for Vaccine Research, World Health Organization. Acute Respiratory Infections (Update September 2009) Geneva, Switzerland: World Health Organization; 2009. http://www.who.int/vaccine_research/diseases/ari/en/index1.html. (Accessed September 6, 2011)
    1. Smith NM, Bresee JS, Shay DK, et al. Prevention and control of influenza: recommendations of the Advisory Committee on Immunization Practices (ACIP) MMWR Recomm Rep. 2006;55(RR-10):1–42. - PubMed
    1. Nichol KL, Nordin J, Mullooly J. Influence of clinical outcome and outcome period definitions on estimates of absolute clinical and economic benefits of influenza vaccination in community dwelling elderly persons. Vaccine. 2006;24(10):1562–1568. - PubMed
    1. Jefferson T, Rivetti D, Rivetti A, et al. Efficacy and effectiveness of influenza vaccines in elderly people: a systematic review. Lancet. 2005;366(9492):1165–1174. - PubMed
    1. Monto AS, Hornbuckle K, Ohmit SE. Influenza vaccine effectiveness among elderly nursing home residents: a cohort study. Am J Epidemiol. 2001;154(2):155–160. - PubMed

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