{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2024,1,8]],"date-time":"2024-01-08T19:42:25Z","timestamp":1704742945113},"reference-count":41,"publisher":"Elsevier BV","issue":"10","license":[{"start":{"date-parts":[[2013,2,1]],"date-time":"2013-02-01T00:00:00Z","timestamp":1359676800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Vaccine"],"published-print":{"date-parts":[[2013,2]]},"DOI":"10.1016\/j.vaccine.2012.07.090","type":"journal-article","created":{"date-parts":[[2012,8,10]],"date-time":"2012-08-10T22:01:18Z","timestamp":1344636078000},"page":"1438-1446","source":"Crossref","is-referenced-by-count":7,"title":["A population based cohort study to assess the safety of pandemic influenza vaccine Focetria\u00ae in Emilia-Romagna region, Italy\u2014Part Two"],"prefix":"10.1016","volume":"31","author":[{"given":"Maria Luisa","family":"Moro","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lucia","family":"Nobilio","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Claudio","family":"Voci","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Simona","family":"Di Mario","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Silvia","family":"Candela","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nicola","family":"Magrini","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"78","reference":[{"key":"10.1016\/j.vaccine.2012.07.090_bib0005","doi-asserted-by":"crossref","first-page":"250","DOI":"10.1186\/1743-422X-8-250","article-title":"Evolutionary genomics of the pandemic 2009 H1N1 influenza viruses (pH1N 1v)","volume":"8","author":"Qu","year":"2011","journal-title":"Virol J"},{"key":"10.1016\/j.vaccine.2012.07.090_bib0010","first-page":"400","article-title":"Swine influenza A (H1N1) infection in two children\u2013\u2013southern California, March\u2013April 2009","volume":"58","author":"Centers for Disease Control and Prevention","year":"2009","journal-title":"MMWR Morb Mortal Wkly Rep"},{"key":"10.1016\/j.vaccine.2012.07.090_bib0015","first-page":"467","article-title":"Outbreak of swine-origin influenza A (H1N1) virus infection\u2013\u2013Mexico, March\u2013April 2009","volume":"58","author":"Centers for Disease Control and Prevention","year":"2009","journal-title":"MMWR Morb Mortal Wkly Rep"},{"key":"10.1016\/j.vaccine.2012.07.090_bib0020","unstructured":"World Health Organization. Guidelines for Pharmacological Management of Pandemic Influenza A(H1N1) 2009 and other Influenza viruses. World Health Organization, Geneva. Revised February 2010. Part I Recommendations. Available at: http:\/\/www.who.int\/csr\/resources\/publications\/swineflu\/h1n1_guidelines_pharmaceutical_mngt.pdf [last accessed 06.06.12]."},{"key":"10.1016\/j.vaccine.2012.07.090_bib0025","series-title":"WHO Guidance document Pandemic influenza preparedness and response","author":"World Health Organization","year":"2010"},{"key":"10.1016\/j.vaccine.2012.07.090_bib0030","doi-asserted-by":"crossref","first-page":"45","DOI":"10.1056\/NEJMoa0907673","article-title":"Pediatric hospitalizations associated with 2009 pandemic influenza A (H1N1) in Argentina","volume":"362","author":"Libster","year":"2010","journal-title":"N Engl J Med"},{"key":"10.1016\/j.vaccine.2012.07.090_bib0035","doi-asserted-by":"crossref","first-page":"1935","DOI":"10.1056\/NEJMoa0906695","article-title":"Hospitalized patients with 2009 H1N1 influenza in the United States, April\u2013June 2009","volume":"361","author":"Jain","year":"2009","journal-title":"N Engl J Med"},{"key":"10.1016\/j.vaccine.2012.07.090_bib0040","doi-asserted-by":"crossref","first-page":"1880","DOI":"10.1001\/jama.2009.1536","article-title":"Critically Ill patients with 2009 influenza A(H1N1) in Mexico","volume":"302","author":"Dom\u00ednguez-Cherit","year":"2009","journal-title":"JAMA"},{"key":"10.1016\/j.vaccine.2012.07.090_bib0045","doi-asserted-by":"crossref","first-page":"27","DOI":"10.1056\/NEJMoa0910444","article-title":"Severe 2009 H1N1 influenza in pregnant and postpartum women in California","volume":"362","author":"Louie","year":"2010","journal-title":"N Engl J Med"},{"key":"10.1016\/j.vaccine.2012.07.090_bib0050","unstructured":"ECDC. Revised pandemic 2009 planning assumptions for Europe. 16 September 2009. Available at: http:\/\/ecdc.europa.eu\/en\/activities\/sciadvice\/Lists\/ECDC%20Reviews\/ECDC_DispForm.aspx?List=512ff74f%2D77d4%2D4ad8%2Db6d6%2Dbf0f23083f30&ID=650 (last accessed 06.06.12)."},{"key":"10.1016\/j.vaccine.2012.07.090_bib0055","unstructured":"ECDC. Planning Assumptions for the First Wave of Pandemic A (H1N1) 2009 in Europe.29 July 2009. Available at: http:\/\/ecdc.europa.eu\/en\/healthtopics\/Documents\/0908_InfluenzaA_H1N1_Planning_Assumptions_for_the_First_Wave_of_Pandemic_A(H1N1)_2009_in_Europe.pdf (last accessed 06.06.12)."},{"key":"10.1016\/j.vaccine.2012.07.090_bib0060","unstructured":"Salisbury D, Ramsey M (Eds.), Pandemic influenza A(H1N1)v 2009 (swine flu). Chapter 23a. Immunisation against infectious disease, 3rd edition. 2006. DH, London. Date of last chapter update 21 October 2009. Available at: http:\/\/www.dh.gov.uk\/prod_consum_dh\/groups\/dh_digitalassets\/@dh\/@en\/documents\/digitalasset\/dh_107408.pdf (last accessed 06.06.12)."},{"key":"10.1016\/j.vaccine.2012.07.090_bib0065","doi-asserted-by":"crossref","first-page":"3955","DOI":"10.1016\/j.vaccine.2007.02.045","article-title":"MF59-adjuvanted influenza vaccine confers superior immunogenicity in adult subjects (18\u201360 years of age) with chronic diseases who are at risk of post-influenza complications","volume":"25","author":"Baldo","year":"2007","journal-title":"Vaccine"},{"key":"10.1016\/j.vaccine.2012.07.090_bib0070","doi-asserted-by":"crossref","first-page":"2424","DOI":"10.1056\/NEJMoa0907650","article-title":"Trial of 2009 influenza A (H1N1) monovalent MF59-adjuvanted vaccine","volume":"361","author":"Clark","year":"2009","journal-title":"N Engl J Med"},{"key":"10.1016\/j.vaccine.2012.07.090_bib0075","unstructured":"European Medicines Agency. CHMP Recommendations for the Pharmacovigilance Plan as part of the Risk Management Plan to be submitted with the Marketing Authorisation Application for a Pandemic Influenza Vaccine. London 2009. http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Report\/2010\/01\/WC500051739.pdf (last accessed 06.06.12)."},{"key":"10.1016\/j.vaccine.2012.07.090_bib0080","doi-asserted-by":"crossref","first-page":"1431","DOI":"10.1016\/j.vaccine.2012.06.030","article-title":"An early (3\u20136 weeks) active surveillance study to assess the safety of a pandemic influenza vaccine Focetria\u00ae in a Province of Emilia-Romagna Region, Italy\u2014Part one","volume":"31","author":"Candela","year":"2013","journal-title":"Vaccine"},{"key":"10.1016\/j.vaccine.2012.07.090_bib0085","unstructured":"Regional health authority informative system website, available at: https:\/\/siseps.regione.emilia-romagna.it\/flussi\/servlet\/fv\/AdapterHTTP?ACTION_NAME=cmsNavigate&CODMENU=ROOT&NEW_SESSION=TRUE [in Italian] (last accessed 06.06.12)."},{"key":"10.1016\/j.vaccine.2012.07.090_bib0090","unstructured":"VAESCO. Armonizing vaccine safety in Europe. Background rates. Available at: http:\/\/vaesco.net\/vaesco\/results\/BGR-2010.html (last accessed 06.06.12)."},{"key":"10.1016\/j.vaccine.2012.07.090_bib0095","doi-asserted-by":"crossref","first-page":"179","DOI":"10.1016\/j.jinf.2008.07.004","article-title":"Resistance to fluoroquinolones and treatment failure\/short-term relapse of community-acquired urinary tract infections caused by Escherichia coli","volume":"57","author":"Gagliotti","year":"2008","journal-title":"J Infect"},{"key":"10.1016\/j.vaccine.2012.07.090_bib0100","doi-asserted-by":"crossref","first-page":"328","DOI":"10.1111\/j.1469-0691.2006.01615.x","article-title":"Emergence of ciprofloxacin resistance in Escherichia coli isolates from outpatient urine samples","volume":"13","author":"Gagliotti","year":"2007","journal-title":"Clin Microbiol Infect"},{"key":"10.1016\/j.vaccine.2012.07.090_bib0105","doi-asserted-by":"crossref","first-page":"232","DOI":"10.1258\/135581905774414259","article-title":"Using pharmacy data to identify those with chronic conditions in Emilia Romagna, Italy","volume":"10","author":"Maio","year":"2005","journal-title":"J Health Serv Res Policy"},{"key":"10.1016\/j.vaccine.2012.07.090_bib0110","doi-asserted-by":"crossref","first-page":"843","DOI":"10.1093\/aje\/kwq198","article-title":"Treatment effects in the presence of unmeasured confounding: dealing with observations in the tails of the propensity score distribution\u2014a simulation study","volume":"172","author":"St\u00fcrmer","year":"2010","journal-title":"Am J Epidemiol"},{"key":"10.1016\/j.vaccine.2012.07.090_bib0115","doi-asserted-by":"crossref","first-page":"S131","DOI":"10.1097\/MLR.0b013e318070c08e","article-title":"Increasing levels of restriction in pharmacoepidemiologic database studies of elderly and comparison with randomized trial results","volume":"45","author":"Schneeweiss","year":"2007","journal-title":"Med Care"},{"key":"10.1016\/j.vaccine.2012.07.090_bib0120","doi-asserted-by":"crossref","first-page":"1621","DOI":"10.1093\/jnci\/djr387","article-title":"Predictors and outcomes of limited resection for early-stage non-small cell lung cancer","volume":"103","author":"Billmeier","year":"2011","journal-title":"J Natl Cancer Inst"},{"key":"10.1016\/j.vaccine.2012.07.090_bib0125","unstructured":"ClinicalTrails.Gov. Observational safety and effectiveness study of adjuvanted Swine Origin A (H1N1) Pandemic Subunit Egg Derived Vaccine. Available at: http:\/\/clinicaltrials.gov\/ct2\/show\/NCT01101074?term=NCT01101074&rank=1 (last accessed 06.06.12)."},{"key":"10.1016\/j.vaccine.2012.07.090_bib0130","doi-asserted-by":"crossref","first-page":"373","DOI":"10.1055\/s-0031-1283278","article-title":"Influenza: epidemiology, clinical features, therapy, and prevention","volume":"32","author":"Clark","year":"2011","journal-title":"Semin Respir Crit Care Med"},{"key":"10.1016\/j.vaccine.2012.07.090_bib0135","unstructured":"World Health Organization. Clinical management of human infection with pandemic (H1N1) 2009: revised guidance November 2009. Available at: http:\/\/www.who.int\/csr\/resources\/publications\/swineflu\/clinical_management_h1n1.pdf (last accessed 06.06.12)."},{"key":"10.1016\/j.vaccine.2012.07.090_bib0140","doi-asserted-by":"crossref","first-page":"261","DOI":"10.1056\/NEJMra0707279","article-title":"Update on avian influenza A (H5N1) virus infection in humans","volume":"358","author":"Writing Committee of the Second World Health Organization Consultation on Clinical Aspects of Human Infection with Avian Influenza A (H5N1) Virus","year":"2008","journal-title":"N Engl J Med"},{"key":"10.1016\/j.vaccine.2012.07.090_bib0145","unstructured":"World Health Organization. H5N1 avian influenza: Timeline of major events, 12 September 2011. Available at: http:\/\/www.who.int\/influenza\/human_animal_interface\/avian_influenza\/H5N1_avian_influenza_update.pdf (last accessed 06.06.12)."},{"key":"10.1016\/j.vaccine.2012.07.090_bib0150","doi-asserted-by":"crossref","first-page":"1097","DOI":"10.2165\/11539270-000000000-00000","article-title":"Monitoring adverse events of the vaccination campaign against influenza A (H1N1) in the Netherlands","volume":"33","author":"van Puijenbroek","year":"2010","journal-title":"Drug Saf"},{"key":"10.1016\/j.vaccine.2012.07.090_bib0155","doi-asserted-by":"crossref","first-page":"3708","DOI":"10.1016\/j.vaccine.2011.02.097","article-title":"Italian post-marketing surveillance for adverse event reports after MF59-adjuvanted H1N1v vaccination","volume":"29","author":"Parretta","year":"2011","journal-title":"Vaccine"},{"key":"10.1016\/j.vaccine.2012.07.090_bib0160","doi-asserted-by":"crossref","first-page":"8302","DOI":"10.1016\/j.vaccine.2011.08.093","article-title":"Causality assessment of serious neurologic adverse events following 2009 H1N1 vaccination","volume":"29","author":"Williams","year":"2011","journal-title":"Vaccine"},{"key":"10.1016\/j.vaccine.2012.07.090_bib0165","doi-asserted-by":"crossref","first-page":"d5956","DOI":"10.1136\/bmj.d5956","article-title":"Neurological and autoimmune disorders after vaccination against pandemic influenza A (H1N1) with a monovalent adjuvanted vaccine: population based cohort study in Stockholm Sweden","volume":"343","author":"Bardage","year":"2011","journal-title":"BMJ"},{"key":"10.1016\/j.vaccine.2012.07.090_bib0170","doi-asserted-by":"crossref","first-page":"2428","DOI":"10.1016\/S0264-410X(00)00467-9","article-title":"Adverse events and vaccination-the lack of power and predictability of infrequent events in pre-licensure study","volume":"19","author":"Jacobson","year":"2001","journal-title":"Vaccine"},{"key":"10.1016\/j.vaccine.2012.07.090_bib0175","doi-asserted-by":"crossref","first-page":"2115","DOI":"10.1016\/S0140-6736(09)61877-8","article-title":"Importance of background rates of disease in assessment of vaccine safety during mass immunisation with pandemic H1N1 influenza vaccines","volume":"374","author":"Black","year":"2009","journal-title":"Lancet"},{"issue":"July","key":"10.1016\/j.vaccine.2012.07.090_bib0180","doi-asserted-by":"crossref","first-page":"d3908","DOI":"10.1136\/bmj.d3908","article-title":"Guillain-Barre syndrome and adjuvanted pandemic influenza A (H1N1) 2009 vaccine: multinational case\u2013control study in Europe","volume":"343","author":"Dieleman","year":"2011","journal-title":"BMJ"},{"key":"10.1016\/j.vaccine.2012.07.090_bib0185","doi-asserted-by":"crossref","first-page":"9467","DOI":"10.1016\/j.vaccine.2011.10.029","article-title":"Risk of convulsions in children after monovalent H1N1 (2009) and trivalent influenza vaccines: a database study","volume":"29","author":"Stowe","year":"2011","journal-title":"Vaccine"},{"issue":"January (2)","key":"10.1016\/j.vaccine.2012.07.090_bib0190","doi-asserted-by":"crossref","first-page":"e000167","DOI":"10.1136\/bmjopen-2011-000167","article-title":"Effectiveness and safety of the A-H1N1 vaccine in children: a hospital-based case\u2013control study","volume":"1","author":"Italian Multicenter Study Group for Drug and Vaccine Safety in Children","year":"2011","journal-title":"BMJ Open"},{"key":"10.1016\/j.vaccine.2012.07.090_bib0195","doi-asserted-by":"crossref","first-page":"d7901","DOI":"10.1136\/bmj.d7901","article-title":"Effectiveness of vaccine against pandemic influenza A\/H1N1 among people with underlying chronic diseases: cohort study, Denmark, 2009\u201310","volume":"344","author":"Emborg","year":"2011","journal-title":"BMJ"},{"key":"10.1016\/j.vaccine.2012.07.090_bib0200","doi-asserted-by":"crossref","first-page":"196","DOI":"10.1186\/1471-2334-11-196","article-title":"Effectiveness of a MF-59\u2122-adjuvanted pandemic influenza vaccine to prevent 2009 A\/H1N1 influenza-related hospitalisation; a matched case\u2013control study","volume":"11","author":"Steens","year":"2011","journal-title":"BMC Infect Dis"},{"key":"10.1016\/j.vaccine.2012.07.090_bib0205","doi-asserted-by":"crossref","first-page":"313","DOI":"10.3310\/hta14340-05","article-title":"Vaccine effectiveness in pandemic influenza\u2014primary care reporting (VIPER): an observational study to assess the effectiveness of the pandemic influenza A (H1N1)v vaccine","volume":"14","author":"Simpson","year":"2010","journal-title":"Health Technol Assess"}],"container-title":["Vaccine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0264410X1201136X?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0264410X1201136X?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2018,11,21]],"date-time":"2018-11-21T14:58:18Z","timestamp":1542812298000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0264410X1201136X"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2013,2]]},"references-count":41,"journal-issue":{"issue":"10","published-print":{"date-parts":[[2013,2]]}},"alternative-id":["S0264410X1201136X"],"URL":"https:\/\/doi.org\/10.1016\/j.vaccine.2012.07.090","relation":{},"ISSN":["0264-410X"],"issn-type":[{"value":"0264-410X","type":"print"}],"subject":[],"published":{"date-parts":[[2013,2]]}}}