{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,6]],"date-time":"2026-03-06T02:05:42Z","timestamp":1772762742562,"version":"3.50.1"},"reference-count":19,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2019,10,30]],"date-time":"2019-10-30T00:00:00Z","timestamp":1572393600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2019,10,30]],"date-time":"2019-10-30T00:00:00Z","timestamp":1572393600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Ital J Pediatr"],"published-print":{"date-parts":[[2019,12]]},"abstract":"<jats:title>Abstract<\/jats:title>\n              <jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>Invasive meningococcal disease is a serious global health threat in the world; in 2016, the European Centre for Disease Control and Prevention reported 3280 confirmed cases (including 304 deaths) of Invasive Meningococcal Diseases in Europe. In Italy, in 2017 were reported 200 cases 41% of which due to menB serogroup. From January 2013 the European Medicines Agency (EMA) has authorized the marketing of the meningococcal B vaccine 4CMenB.<\/jats:p>\n              <\/jats:sec>\n              <jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>The study aimed to evaluate and complement the safety profile of 4CMenB in high risk children accessing the vaccine service of the Bambino Ges\u00f9 Children\u2019s Hospital. All individuals aged six weeks or more receiving the meningococcal 4CMenB (Bexsero\u00ae) vaccine that approached the vaccine Centre at the Bambino Ges\u00f9 Children\u2019s Hospital in Rome, were asked to participate. All parents or caregivers of vaccinated individuals in the study period, were recruited and requested to answer to a questionnaire on adverse events following immunization (AEFI) observed after 7\u2009days, starting from the date of vaccination.<\/jats:p>\n              <\/jats:sec>\n              <jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>During the study period (October 2016\u2013October 2017), we collected 157 completed questionnaires (out of 200 distributed). Of those 132 were first doses and 25 were booster administered doses. The median age of the study population was 4.5\u2009years (range 0.29 to 26.8\u2009years), the majority of subjects were high-risk individuals (64%) with chronic health conditions. Overall, 311 adverse events were reported in the 7\u2009days after vaccine administration. In particular 147 events (47%) after administration of first dose and 58 (19%) after the booster doses. A large majority of those events, were of little clinical importance and concentrated in the 24\u2009h after vaccine administration. No hospitalizations or Emergency Department access were reported.<\/jats:p>\n              <\/jats:sec>\n              <jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>Results of our study demonstrated that the Bexsero\u00ae vaccine is almost well tolerated, with a low incidence of severe AEFIs. Our results also shown that the occurrence of AEFIs is similar within healthy and high risk children.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s13052-019-0730-y","type":"journal-article","created":{"date-parts":[[2019,10,30]],"date-time":"2019-10-30T23:03:14Z","timestamp":1572476594000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Safety and tolerability of Meningococcus B vaccine in patients with chronical medical conditions (CMC)"],"prefix":"10.1186","volume":"45","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9970-0984","authenticated-orcid":false,"given":"L.","family":"Nicolosi","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"C.","family":"Rizzo","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"G. Castelli","family":"Gattinara","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"N.","family":"Mirante","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"E.","family":"Bellelli","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"C.","family":"Bianchini","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"V.","family":"Pansini","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"A.","family":"Villani","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2019,10,30]]},"reference":[{"issue":"9890","key":"730_CR1","first-page":"368","volume":"382","author":"T Lancet","year":"2013","unstructured":"Lancet T, Meningitis B. Lancet. 2013;382(9890):368.","journal-title":"Lancet"},{"issue":"2","key":"730_CR2","first-page":"116","volume":"53","author":"C Sabatini","year":"2012","unstructured":"Sabatini C, Bosis S, Semino M, Senatore L, Principi N, Esposito S. Clinical presentation of meningococcal disease in childhood. J Prev Med Hyg. 2012;53(2):116\u20139.","journal-title":"J Prev Med Hyg"},{"key":"730_CR3","unstructured":"Invasive meningococcal disease - Annual Epidemiological Report for 2016 [Internet]. [cited 2019 Feb 19]. Available from: \n                    https:\/\/ecdc.europa.eu\/en\/publications-data\/invasive-meningococcal-disease-annual-epidemiological-report-2016"},{"key":"730_CR4","unstructured":"Sorveglianza delle malattie batteriche invasive in Italia RAPPORTO CONSOLIDATO 2017 DIP. MALATTIE INFETTIVE, ISTITUTO SUPERIORE DI SANITA\u2019 [Internet]. [cited 2019 Feb 19]. Available from: \n                    http:\/\/old.iss.it\/binary\/mabi\/cont\/Report2017.pdf"},{"issue":"8","key":"730_CR5","doi-asserted-by":"publisher","first-page":"2075","DOI":"10.1080\/21645515.2018.1466015","volume":"14","author":"AR Giuliani","year":"2018","unstructured":"Giuliani AR, Mattei A, Appetiti A, Pompei D, Di Donna F, Fiasca F, et al. Spontanuous demand for meningococcal B vaccination: effects on appropriateness and timing. Hum Vaccin Immunother. 2018;14(8):2075\u201381.","journal-title":"Hum Vaccin Immunother"},{"key":"730_CR6","unstructured":"De Serres G, Billard M-N, Rouleau I, Gari\u00e9py M-C, Institut national de sant\u00e9 publique du Qu\u00e9bec, Direction des risques biologiques et de la sant\u00e9 au travail, et al. Rapport int\u00e9rimaire de surveillance de la s\u00e9curit\u00e9 de la premi\u00e8re dose du vaccin contre le m\u00e9ningocoque de s\u00e9rogroupe B au Saguenay-Lac-Saint-Jean [Internet]. 2015 [cited 2019 Feb 19]. Available from: \n                    http:\/\/www.deslibris.ca\/ID\/245106"},{"issue":"29","key":"730_CR7","doi-asserted-by":"publisher","first-page":"3322","DOI":"10.1016\/j.vaccine.2015.05.027","volume":"33","author":"J Findlow","year":"2015","unstructured":"Findlow J, Bai X, Findlow H, Newton E, Kaczmarski E, Miller E, et al. Safety and immunogenicity of a four-component meningococcal group B vaccine (4CMenB) and a quadrivalent meningococcal group ACWY conjugate vaccine administered concomitantly in healthy laboratory workers. Vaccine. 2015;33(29):3322\u201330.","journal-title":"Vaccine."},{"issue":"6","key":"730_CR8","doi-asserted-by":"publisher","first-page":"573","DOI":"10.1001\/jama.2012.85","volume":"307","author":"N Gossger","year":"2012","unstructured":"Gossger N, Snape MD, Yu L-M, Finn A, Bona G, Esposito S, et al. Immunogenicity and tolerability of recombinant serogroup B meningococcal vaccine administered with or without routine infant vaccinations according to different immunization schedules: a randomized controlled trial. JAMA. 2012;307(6):573\u201382.","journal-title":"JAMA."},{"issue":"9816","key":"730_CR9","doi-asserted-by":"publisher","first-page":"617","DOI":"10.1016\/S0140-6736(11)61713-3","volume":"379","author":"ME Santolaya","year":"2012","unstructured":"Santolaya ME, O\u2019Ryan ML, Valenzuela MT, Prado V, Vergara R, Mu\u00f1oz A, et al. Immunogenicity and tolerability of a multicomponent meningococcal serogroup B (4CMenB) vaccine in healthy adolescents in Chile: a phase 2b\/3 randomised, observer-blind, placebo-controlled study. Lancet. 2012;379(9816):617\u201324.","journal-title":"Lancet."},{"issue":"34","key":"730_CR10","doi-asserted-by":"publisher","first-page":"4046","DOI":"10.1016\/j.vaccine.2016.06.025","volume":"34","author":"JM Langley","year":"2016","unstructured":"Langley JM, MacDougall DM, Halperin BA, Swain A, Halperin SA, Top KA, et al. Rapid surveillance for health events following a mass meningococcal B vaccine program in a university setting: A Canadian Immunization Research Network study. Vaccine. 2016;34(34):4046\u20139.","journal-title":"Vaccine"},{"issue":"9869","key":"730_CR11","doi-asserted-by":"publisher","first-page":"825","DOI":"10.1016\/S0140-6736(12)61961-8","volume":"381","author":"T Vesikari","year":"2013","unstructured":"Vesikari T, Esposito S, Prymula R, Ypma E, Kohl I, Toneatto D, et al. Immunogenicity and safety of an investigational multicomponent, recombinant, meningococcal serogroup B vaccine (4CMenB) administered concomitantly with routine infant and child vaccinations: results of two randomised trials. Lancet. 2013;381(9869):825\u201335.","journal-title":"Lancet."},{"issue":"5","key":"730_CR12","first-page":"191","volume":"42","author":"M Fern\u00e1ndez-Prada","year":"2018","unstructured":"Fern\u00e1ndez-Prada M, Mart\u00ednez-Ortega C, Hidalgo-Pe\u00f1a L, \u00c1lvarez-V\u00e1zquez C, Aguirre-Del Pino R, Huerta-Gonz\u00e1lez I. Adverse reactions associated with meningococcal group B vaccine (4CMenB) in adults in special situations. Farm Hosp. 2018;42(5):191\u20136.","journal-title":"Farm Hosp"},{"key":"730_CR13","unstructured":"Meningococcal September 2016. MENINGOCOCCAL MENINGITIS AND SEPTICAEMIA NOTIFIABLE [Internet]. [cited 2019 Feb 22]. Available from: \n                    https:\/\/assets.publishing.service.gov.uk\/government\/uploads\/system\/uploads\/attachment_data\/file\/554011\/Green_Book_Chapter_22.pdf"},{"key":"730_CR14","unstructured":"Anonymous. Bexsero [Internet]. European Medicines Agency - Commission. 2018 [cited 2019 Feb 28]. Available from: \n                    https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/bexsero"},{"issue":"52","key":"730_CR15","doi-asserted-by":"publisher","first-page":"8039","DOI":"10.1016\/j.vaccine.2018.10.095","volume":"36","author":"G De Serres","year":"2018","unstructured":"De Serres G, Billard M-N, Gari\u00e9py M-C, Rouleau I, Toth E, Landry M, et al. Short-term safety of 4CMenB vaccine during a mass meningococcal B vaccination campaign in Quebec. Canada Vaccine. 2018;36(52):8039\u201346.","journal-title":"Canada Vaccine"},{"issue":"11","key":"730_CR16","doi-asserted-by":"publisher","first-page":"2304","DOI":"10.4161\/hv.25505","volume":"9","author":"ME Santolaya","year":"2013","unstructured":"Santolaya ME, O\u2019Ryan M, Valenzuela MT, Prado V, Vergara RF, Mu\u00f1oz A, et al. Persistence of antibodies in adolescents 18\u221224 months after immunization with one, two, or three doses of 4CMenB meningococcal serogroup B vaccine. Hum Vaccin Immunother. 2013;9(11):2304\u201310.","journal-title":"Hum Vaccin Immunother."},{"issue":"3","key":"730_CR17","doi-asserted-by":"publisher","first-page":"483","DOI":"10.1128\/CVI.00304-10","volume":"18","author":"A Kimura","year":"2011","unstructured":"Kimura A, Toneatto D, Kleinschmidt A, Wang H, Dull P. Immunogenicity and safety of a multicomponent meningococcal serogroup B vaccine and a quadrivalent meningococcal CRM197 conjugate vaccine against serogroups a, C, W-135, and Y in adults who are at increased risk for occupational exposure to meningococcal isolates. Clin Vaccine Immunol. 2011;18(3):483\u20136.","journal-title":"Clin Vaccine Immunol"},{"key":"730_CR18","unstructured":"N\u00b0366 - Avril 2014 [Internet]. [cited 2019 Feb 28]. Available from: \n                    http:\/\/www.prescrire.org\/Fr\/SummaryDetail.aspx?\n                    \n                   IssueId=366."},{"issue":"3","key":"730_CR19","doi-asserted-by":"publisher","first-page":"263","DOI":"10.1007\/s40259-013-0029-2","volume":"27","author":"NJ Carter","year":"2013","unstructured":"Carter NJ. Multicomponent meningococcal serogroup B vaccine (4CMenB; Bexsero(\u00ae)): a review of its use in primary and booster vaccination. BioDrugs. 2013;27(3):263\u201374.","journal-title":"BioDrugs."}],"container-title":["Italian Journal of Pediatrics"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1186\/s13052-019-0730-y.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/article\/10.1186\/s13052-019-0730-y\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1186\/s13052-019-0730-y.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2020,10,29]],"date-time":"2020-10-29T00:19:38Z","timestamp":1603930778000},"score":1,"resource":{"primary":{"URL":"https:\/\/ijponline.biomedcentral.com\/articles\/10.1186\/s13052-019-0730-y"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,10,30]]},"references-count":19,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2019,12]]}},"alternative-id":["730"],"URL":"https:\/\/doi.org\/10.1186\/s13052-019-0730-y","relation":{},"ISSN":["1824-7288"],"issn-type":[{"value":"1824-7288","type":"electronic"}],"subject":[],"published":{"date-parts":[[2019,10,30]]},"assertion":[{"value":"16 April 2019","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"10 October 2019","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"30 October 2019","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"This study was approved by the ethical committee of the Bambino Ges\u00f9 Children\u2019s Hospital (Prot. 1171 in date 27\/09\/2016).; written informed consent was provided by parents of all participants.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare that they have no competing interests.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"133"}}