Surveillance of adverse events following immunization with meningococcal group C conjugate vaccine: Tuscany, 2005-2012

Introduction. Post-licensure vaccine safety studies are essential to identify uncommon events that may be difficult to assess during prelicensure studies. The aim of our study was to evaluate the safety of serogroup C meningococcal conjugate (MCC) vaccine in Tuscany from 2005 to 2012. Methods. All adverse events (AEs) to MCC vaccine notified from 2005 to 2012 were obtained from the regional health authority. Results. Following 451,570 doses administered, 110 suspected AEs were notified (mean annual reporting rate: 2.8/10,000 doses). The most frequently AE reported was fever (60%), fol- lowed by swelling at the injection site (11%) and febrile seizures (10%). Overall, 77.3% of cases were not severe, while 21.8% required hospitalization. Almost four months after the receipt of the vaccine, a one-year-old infant was diagnosed with a pervasive developmental disorder with disturbance of speech, but any link with the vaccinations received was refuted. Most AEs (80.9%) occurred after co-administration with other vaccines, especially with MMR or MMRV vaccines (42.7%) or the DTPa-HBV-IPV/ Hib vaccine (33.7%). Discussion. Our study confirmed the high level of safety of MCC vaccine in Tuscany: AEs proved rare and all cases had only tem- porary and self-resolving consequences. As usually only the most severe suspected AEs are reported, the true proportion of AEs requiring hospitalization was most probably overestimated, and it is plausible that most of these cases were in fact only temporally related

Non invasive diagnosis and anatomo-clinical correlations of macrocystic pancreatic neoplasia

Pancreatic cystic tumors represent an heterogeneous group of neoplasms with a various clinical outcome. The incidence of these neoplasia is growing if compared with the past and this is mainly due to the larger use of more and more performing imaging techniques. The role of MRI and in particular of Cholangio-Pancreato Magnetic Resonance (CPMR) seems to be fundamental in the characterization of these cystic lesions. Between May 2009 and May 2011 a hundred and seventy six (176) patients with a suspect cystic lesion of the pancreas were evaluated. All patients had already undergone ultrasound and/or CT scan. CPMR was realized in each patient. Among these patients we only considered 51 without neither solid lesions or pseudocysts nor clear signs of malignancy. We found 10 Serous Cystic Tumors (SCT), 7 Mucinous Cystic Tumors (MCT) and 34 Intraductal Papillary Mucinous Neoplasia (IPMN). Thirty two (32) out of 34 IPMN revealed at CPMR a communication with the main pancreatic duct. This sign is pathognomonic of these lesions. CPMR seems to be mandatory to discriminate IPMN among the other pancreatic cystic neoplasia. Its role is fundamental for an early diagnosis and to give the best chance of cure in these aggressive and insidious tumors

Budget impact analysis of universal rotavirus vaccination in the Local Health Unit 11 Empoli, Tuscany, Italy

Background. Rotavirus (RV) infection is the first cause of acute viral gastroenteritis in children under five years of age all over the world; it mainly affects children between six and 24 months of age and can cause serious acute diarrhoea and dehydration. The aim of this study is to perform the budget impact analysis of universal rotavirus vaccination in the Local Health Unit (LHU) 11 Empoli, Tuscany, Italy.Methods. An ad hoc mathematical simulation model was developed to evaluate the budget impact analysis of 5-years universal rotavirus vaccination. Particularly, incidence of rotavirus gastroenteritis (RVGE), hospitalizations, nosocomial diarrhoea, medical consultations, prescriptions and accesses to emergency department were taken into account in the analysis. The direct medical costs due to RV diarrhoea and the costs of vaccination campaign were considered as the main outcome measures in the study.Results. The adoption of universal rotavirus vaccination campaign for five years in the LHU 11 Empoli results in relevant savings due to the health cares avoided. These savings would overlapped the costs of vaccination yet from the second year after the introduction of vaccination. The saving for the Health Service would be 1.5 million Euro after five years of campaign.Conclusions. Universal vaccination against rotavirus results clinically and economically favourable for both the Health Service and the Society perspectives