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1. Post-marketing active surveillance of Guillain Barré Syndrome following COVID-19 vaccination in persons aged ≥12 years in Italy: A multi-database self-controlled case series study

Author

Morciano, C., Spila Alegiani, Stefania, Menniti Ippolito, F., Belleudi, V., Trifirò, G., Zanoni, G., Puccini, A., Sapigni, E., Mores, Nadia, Leoni, O., Monaco, G., Clagnan, E., Zappetti, C., Bovo, E., Cutillo, M., Da Cas, R., Massari, M., Spila Alegiani S., Mores N. (ORCID:0000-0002-4197-0914), Morciano, C., Spila Alegiani, Stefania, Menniti Ippolito, F., Belleudi, V., Trifirò, G., Zanoni, G., Puccini, A., Sapigni, E., Mores, Nadia, Leoni, O., Monaco, G., Clagnan, E., Zappetti, C., Bovo, E., Cutillo, M., Da Cas, R., Massari, M., Spila Alegiani S., and Mores N. (ORCID:0000-0002-4197-0914)

Abstract

Background: Recently published studies have reported association of COVID-19 vaccine ChAdOx1-S (Vaxzevria) with Guillain Barré Syndrome (GBS). Less is known about the safety of other COVID-19 vaccines with respect to GBS outcome. This study investigated the association of COVID-19 vaccines with GBS in more than 15 million persons aged ≥12 years in Italy. Methods: Study population was all individuals aged ≥12 years who received at least one dose of COVID-19 vaccines, admitted to emergency care/hospital for GBS from 27 December 2020-30 September 2021 in Italy. Identification of GBS cases and receipt of at least one dose of mRNA-1273 (Elasomeran), BNT162b2 (Tozinameran), ChAdOx1-S (Vaxzevria) and Ad26.COV2.S (Janssen) through record linkage between regional health care and vaccination registries. Relative Incidence (RI) was estimated Self-controlled case series method adapted to event-dependent exposure using in the 42-day exposure risk period after each dose compared with other observation periods. Results: Increased risk of GBS was found after first (RI = 6.83; 95% CI 2.14-21.85) and second dose (RI = 7.41; 2.35-23.38) of mRNA-1273 and first dose of ChAdOx1-S (RI = 6.52; 2.88-14.77). Analysis by age found an increased risk among those aged≥60 years after first (RI = 8.03; 2.08-31.03) and second dose (RI = 7.71; 2.38-24.97) of mRNA-1273. The first dose of ChAdOx1-S was associated with GBS in those aged 40-59 (RI = 4.50; 1.37-14.79) and in those aged ≥ 60 years (RI = 6.84; 2.56-18.28). Conclusions: mRNA-1273 and ChAdOx1-S vaccines were associated with an increased risk of GBS however this risk resulted in a small number of excess cases. Limitations were loss of GBS outpatient cases and imprecision of the estimates in the subgroup analysis due to a low number of events.

Published
2024

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Author

Gatti, M, Ippoliti, I, Poluzzi, E, Antonazzo, I, Moro, P, Moretti, U, Menniti-Ippolito, F, Mazzanti, G, De Ponti, F, Raschi, E, Gatti M., Ippoliti I., Poluzzi E., Antonazzo I. C., Moro P. A., Moretti U., Menniti-Ippolito F., Mazzanti G., De Ponti F., Raschi E., Gatti, M, Ippoliti, I, Poluzzi, E, Antonazzo, I, Moro, P, Moretti, U, Menniti-Ippolito, F, Mazzanti, G, De Ponti, F, Raschi, E, Gatti M., Ippoliti I., Poluzzi E., Antonazzo I. C., Moro P. A., Moretti U., Menniti-Ippolito F., Mazzanti G., De Ponti F., and Raschi E.

Abstract

Background & aims: Alpha-lipoic acid (ALA)-containing dietary supplements are widely used in clinical practice, although their safety assessment is under-investigated. We characterize the safety profile of ALA-containing products by analysing spontaneous reports of suspected adverse reactions (ARs). Methods: Suspected ARs to ALA-containing products were extracted from the Italian Phytovigilance System (IPS), and scrutinized in terms of seriousness and causality (through WHO UMC system), with a specific focus on important (IMEs) and designated medical events (DMEs). To characterize the reporting profile from an international perspective, the WHO-VigiBase was also queried. Results: From March 2002 to February 2020, out of 2147 total reports, 116 reports concerning 212 ARs to ALA-containing products were collected. Women were involved in 68.1% of cases. Skin (44.9%) and gastrointestinal disorders (10.8%) were the most frequently represented ARs. Causality assessment resulted as definite (15), probable (35), possible (24), unlikely (5), and unclassifiable (37). In 70% of cases, events occurred within 30 days of ALA use. Forty-five reports were serious (38.8%), being insulin autoimmune syndrome the most frequently reported (N = 10). IMEs were recorded in 20 cases, including four DMEs (3 angioedema and one anaphylactic shock). Similar distribution emerged from the 5641 reports in the WHO-VigiBase. Conclusions: The remarkable reporting of unpredictable skin, immune and hepatic ARs, coupled with seriousness, strong causality and early onset, calls for a) careful risk-benefit assessment of ALA-containing products by regulators; b) awareness and monitoring by clinicians and c) continuous vigilance of their safety profile through valuable spontaneous reporting systems such as IPS.

Published
2021

3. Reply-Letter to the editor - The valuable support of spontaneous reporting systems in exploring safety profile of dietary supplements

Author

Gatti, M, Ippoliti, I, Poluzzi, E, Antonazzo, I, Moro, P, Moretti, U, Menniti-Ippolito, F, Mazzanti, G, De Ponti, F, Raschi, E, Gatti M., Ippoliti I., Poluzzi E., Antonazzo I. C., Moro P. A., Moretti U., Menniti-Ippolito F., Mazzanti G., De Ponti F., Raschi E., Gatti, M, Ippoliti, I, Poluzzi, E, Antonazzo, I, Moro, P, Moretti, U, Menniti-Ippolito, F, Mazzanti, G, De Ponti, F, Raschi, E, Gatti M., Ippoliti I., Poluzzi E., Antonazzo I. C., Moro P. A., Moretti U., Menniti-Ippolito F., Mazzanti G., De Ponti F., and Raschi E.

Published
2020

4. The Di Bella Multitherapy Trial

Author

Liberati, Alessandro, Magrini, Nicola, Patoia, Lucio, Pagliaro, Luigi, Raschetti, R., Greco, D., Menniti-Ippolito, F., Spila-Alegiani, S., Traversa, G., Benagiano, G., Bruzzi, P., Müllner, Marcus, and Evans, Stephen J. W.

Published
1999

6. The need for European harmonization of Nutrivigilance in a public health perspective: a comprehensive review.

Author

Vo Van Regnault, G., Costa, M. C., Adanić Pajić, A., Bico, A. P., Bischofova, S., Blaznik, U., Menniti-Ippolito, F., Pilegaard, K., Rodrigues, C., and Margaritis, I.

Abstract

According to the European Union regulation, some countries have established a pre-market notification system for food supplements while others have not. As this regulation is unfulfilled, a notified and marketed food supplement ingredient in one country may be forbidden in another. Even though food supplements shall not be placed on the market if unsafe, some products may still expose the consumers to risks. The risk is increased by easier access due to worldwide dissemination fostered by the internet and free movement of goods in the European Union. The Rapid Alert System for Food and Feed and the Emerging Risks Exchange Network are described. To date, the European Union legislation does not include a provision to establish a dedicated vigilance system for food supplements (Nutrivigilance). Six European Union countries have nevertheless set up national systems, which are presented. The present lack of European Union data collection harmonization, does not allow easy cooperation between countries. This article advocates for creating a coordinated European Nutrivigilance System to detect and scrutinize adverse effects of food supplements. This, to help in directing science-based risk assessments and reinforce the science-based decision of policy makers to improve public health safety. [ABSTRACT FROM AUTHOR]

Published
2022
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19. A Case of Severe Methemoglobinemia in a Baby Fed Homemade Decoction of Silverbeet

Author

Moro, P.A., Benedetti, M., Biban, P., Cassetti, F., Milani, F., Menniti-Ippolito, F., Raschetti, R., and Menniti-ippolito, F.

Subjects
Methemoglobinemia, nitrates, silverbeet, complementary therapies, food poisoning, Traditional medicine, Health professionals, business.industry, Decoction, medicine.disease, medicine, Settore BIO/15 - Biologia Farmaceutica, business
Abstract

This report describes a case of severe methemoglobinemia in a baby fed with a homemade decoction of silverbeet (Beta vulgaris L. var. cicla). Lay people and health professionals must be aware of possible risks associated with the use of folk herbal remedies in infants that, despite being natural, may be not as safe as claimed.

Published
2013
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22. Poster Presentations

Author

Menniti-Ippolito, F., Mazzanti, G., Santuccio, C., Morro, P., Calapai, G., Firenzuoli, F., Valeri, A., and Raschetti, R.

Published
2007
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23. Oral Presentations

Author

Menniti-Ippolito, F., Mazzanti, G., Santuccio, C., Moro, P., Calapai, G., Firenzuoli, F., Valeri, A., and Raschetti, R.

Published
2007
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25. How legislation on decisional capacity can negatively affect the feasibility of clinical trials in patients with dementia

Author

Galeotti, F, Vanacore, N, Gainotti, S, Izzicupo, F, Menniti Ippolito, F, Petrini, C, Chiarotti, F, Chattat, R, Raschetti, R, AdCare Study Group: Popoli, P, Potenza, R, Tebano, Mt, Giubilei, F, Locuratolo, N, Bruno, G, Piacentini, E, Talarico, G, Gasparini, M, Del Re ML, Bruni, A, Colao, R, Puccio, G, Curcio, S, Clodimiro, A, Caffarra, P, Messa, G, Concari, L, Pagliara, B, Fabbo, A, Zucchi, P, Bonora, A, Veschi, M, Carbone, G, Ursino, R, Fatica, L, De Bonis, C, Gainotti, G, Marra, C, Quaranta, D, Zinno, M, Rodriguez, Guido, Nobili, FLAVIO MARIANO, Barbieri, Mp, Dessi, B, Mazzei, D, Arnaldi, Dario, Brugnolo, Andrea, Clerici, F, Mariani, C, Maggiore, L, Pomati, S, Padovani, A, Rozzini, L, Zanetti, M, Conti, M, Chinaglia, C, Engaddi, I, De Domenico, D, Savorgnan, G, Scarpino, O, Civerchia, P, Raccichini, A, Specchio, Lm, Goffredo, R, Biancardi, Me, Putzu, V, Araujo, Y, Ballisai, A, Piras, Mr, Cherchi, R, Bagella, Cf, Deiana, E, Giordano, M, Pineo, A, Catania, Tm, Bracco, L, Piccini, C, Mecocci, P, Feliziani, Ft, Cornacchiola, V, Gambina, G, Broggio, E, Sala, F., Galeotti F, Vanacore N, Gainotti S, Izzicupo F, Menniti-Ippolito F, Petrini C, Chiarotti F, Chattat R, Raschetti R, and AdCare Study Group

Subjects
Olanzapine, medicine.medical_specialty, medicine.drug_class, medicine.medical_treatment, Decision Making, Atypical antipsychotic, law.invention, Randomized controlled trial, Informed consent, law, Humans, Medicine, Mental Competency, Pharmacology (medical), Antipsychotic, Psychiatry, legal, Clinical Trials as Topic, Risperidone, business.industry, Patient Selection, CAPACITY, BPSD, antipsychotic, Clinical trial, Settore MED/26 - NEUROLOGIA, Feasibility Studies, Quetiapine, Dementia, Geriatrics and Gerontology, business, medicine.drug
Abstract

Antipsychotic drugs are widely used to treat behavioural and psychological disturbances associated with Alzheimer's disease (AD), although only modest evidence from randomized controlled trials supports their efficacy, and increasing evidence from post-marketing surveillance shows serious adverse events associated with their use, including increased mortality. The AdCare study, a non-profit, randomized, placebo-controlled, double-blind, multicentre, pragmatic trial coordinated by the Italian National Institute of Health, aimed to evaluate the long-term safety and efficacy profiles of three atypical antipsychotic drugs (risperidone, olanzapine and quetiapine) and one conventional antipsychotic drug (haloperidol) in treating psychosis, aggression and agitation in outpatients with AD. The study was planned to be carried out in 19 clinical centres and to enrol 1000 outpatients. According to Italian law, in the case where a patient is considered unable to give informed consent, a legal representative designated by the court has to provide it. Because of difficulties in the informed consent procedure, the study had to be prematurely interrupted. From February 2009 to April 2010, 83 patients gave informed consent to participate in the trial. Fifty-six patients (68%) were included with consent given by a legal representative, while 27 patients (32%) were considered to provide personal informed consent on the basis of the results from a specifically built procedure. Patients and caregivers were offered the opportunity to participate in the trial before the occurrence of behavioural disturbances, in order to provide them with enough time to consider their participation in the study. Twenty-three patients experienced behavioural, clinically relevant symptoms and were randomized to the study drug; all randomized patients except one had consent for inclusion in the study given by legal representatives. After trial interruption, all patients taking an active drug continued treatment with the same molecule in clinical practice. Randomized controlled trials are acknowledged as the gold standard source of evidence on drug safety and efficacy. The AdCare study showed that an excessively rigid regulation can become a major obstacle while carrying out therapeutic research with incapacitated persons.

Published
2012

27. Effectiveness and safety of the A-H1N1 vaccine in children: a hospital-based case-control study

Author

Menniti Ippolito F, Da Cas R, Sagliocca L, Traversa G, Ferrazin F, Santuccio C, Tartaglia L, Trotta F, Di Pietro P, Renna S, Rossi R, Domenichini B, Gamba S, Trovato F, Tovo P, Bianciotto M, Calitri C, Gabiano C, Raffaldi I, Urbino A, Da Dalt L, Bavero V, Giordano L, Baraldi M, Bertuola F, Lorenzon E, Parata F, Perilongo G, Vendramin S, Frassineti M, Calvani AM, Chiappini E, De Martino M, Fancelli C, Mannelli F, Mazzantini R, Sollai S, Venturini E, Pirozzi N, Rauchi U, Reale A, Mores N, Bersani G, De Nisco A, Chiaretti A, Riccardi R, Romagnoli C, Tipo V, Dinardo M, Pisapia T, RAFANIELLO, Concetta, Fucà F, Di Rosa E., CAPUANO, Annalisa, PARRETTA, Elisabetta, Menniti Ippolito, F, Da Cas, R, Sagliocca, L, Traversa, G, Ferrazin, F, Santuccio, C, Tartaglia, L, Trotta, F, Di Pietro, P, Renna, S, Rossi, R, Domenichini, B, Gamba, S, Trovato, F, Tovo, P, Bianciotto, M, Calitri, C, Gabiano, C, Raffaldi, I, Urbino, A, Da Dalt, L, Bavero, V, Giordano, L, Baraldi, M, Bertuola, F, Lorenzon, E, Parata, F, Perilongo, G, Vendramin, S, Frassineti, M, Calvani, Am, Chiappini, E, De Martino, M, Fancelli, C, Mannelli, F, Mazzantini, R, Sollai, S, Venturini, E, Pirozzi, N, Rauchi, U, Reale, A, Mores, N, Bersani, G, De Nisco, A, Chiaretti, A, Riccardi, R, Romagnoli, C, Tipo, V, Dinardo, M, Pisapia, T, Capuano, Annalisa, Parretta, Elisabetta, Rafaniello, Concetta, Fucà, F, and Di Rosa, E.

Published
2011

29. Vaccine effectiveness against severe laboratory-confirmed influenza in children: results of two consecutive seasons in Italy

Author

Menniti Ippolito, F, Da Cas, R, Traversa, G, Santuccio, C, Felicetti, P, Tartaglia, L, Trotta, F, Di Pietro, P, Barabino, P, Renna, S, Riceputi, L, Tovo, Pier Angelo, Gabiano, C, Urbino, A, Baroero, L, Le Serre, D, Virano, S, Perilongo, G, Daverio, M, Gnoato, E, Maretti, M, Galeazzo, B, Rubin, G, Scanferla, S, Da Dalt, L, Stefani, C, Zerbinati, C, Chiappini, E, Sollai, S, De Martino, M, Mannelli, F, Becciani, S, Giacalone, M, Montano, S, Remaschi, G, Stival, A, Furbetta, M, Abate, P, Leonardi, I, Pirozzi, N, Raucci, U, Reale, A, Rossi, R, Russo, C, Mancinelli, L, Manuela, O, Carlo, C, Mores, N, Romagnoli, C, Chiaretti, A, Compagnone, A, Riccardi, R, Delogu, G, Sali, M, Prete, V, Tipo, V, Dinardo, M, Auricchio, F, Polimeno, T, Sodano, G, Maccariello, A, Rafaniello, C, Fucà, F, Di Rosa, E, Altavilla, D, Mecchio, A, Arrigo, T, Italian Multicentre Study Group for Drug, Vaccine Safety in Children, Menniti Ippolito, Francesca, Da Cas, Roberto, Traversa, Giuseppe, Santuccio, Carmela, Felicetti, Patrizia, Tartaglia, Loriana, Trotta, Francesco, Di Pietro, Pasquale, Barabino, Paola, Renna, Salvatore, Riceputi, Laura, Tovo, Pier Angelo, Gabiano, Clara, Urbino, Antonio, Baroero, Luca, Le Serre, Daniele, Virano, Silvia, Perilongo, Giorgio, Daverio, Marco, Gnoato, Elisa, Maretti, Michela, Galeazzo, Beatrice, Rubin, Giulia, Scanferla, Stefania, Da Dalt, Liviana, Stefani, Chiara, Zerbinati, Claudia, Chiappini, Elena, Sollai, Sara, De Martino, Maurizio, Mannelli, Francesco, Becciani, Sabrina, Giacalone, Martina, Montano, Simona, Remaschi, Giulia, Stival, Alessia, Furbetta, Mario, Abate, Piera, Leonardi, Ilaria, Pirozzi, Nicola, Raucci, Umberto, Reale, Antonino, Rossi, Rossella, Russo, Cristina, Mancinelli, Livia, Manuela, Onori, Carlo, Concato, Mores, Nadia, Romagnoli, Costantino, Chiaretti, Antonio, Compagnone, Adele, Riccardi, Riccardo, Delogu, Giovanni, Sali, Michela, Prete, Valentina, Tipo, Vincenzo, Dinardo, Michele, Auricchio, Fabiana, Polimeno, Teodoro, Sodano, Giuseppe, Maccariello, Alessandra, Rafaniello, Concetta, Fucà, Fortunata, Di Rosa, Eleonora, Altavilla, Domenica, Mecchio, Anna, and Arrigo, Teresa

Subjects
Male, Pediatrics, Laboratory-confirmed case, Emergency Medical Services, Immunology and Microbiology (all), Laboratory-confirmed cases, Case-control study, Children, Influenza vaccine effectiveness, Seasonal influenza, Influenza vaccine effectivene, Emergency medical services, Medicine, Child, Vaccine effectiveness, Vaccination, Hospitalization, Systematic review, Infectious Diseases, Treatment Outcome, Settore MED/38 - PEDIATRIA GENERALE E SPECIALISTICA, Italy, Influenza Vaccines, Child, Preschool, Molecular Medicine, Veterinary (all), Female, Case-Control Studie, Influenza Vaccine, Settore BIO/19 - MICROBIOLOGIA GENERALE, Human, medicine.medical_specialty, Settore BIO/14 - FARMACOLOGIA, Adolescent, Settore MED/07 - MICROBIOLOGIA E MICROBIOLOGIA CLINICA, Immunology and Microbiology(all), Influenza, Human, Humans, Influenza-like illness, General Veterinary, General Immunology and Microbiology, business.industry, Emergency Medical Service, Public Health, Environmental and Occupational Health, Infant, Emergency department, veterinary(all), Confidence interval, Surgery, Case-Control Studies, Case-control study, Children, Influenza vaccine effectiveness, Laboratory-confirmed cases, influenza in children, business
Abstract

•Vaccine effectiveness in children visiting an Emergency Department for influenza.•Test negative case-control study in 11 paediatric centres in two influenza seasons.•Vaccine effectiveness in preventing ED visits: 38% (95% CI -52% to 75%).•Add information for recommendation for vaccination in children. Objective: To evaluate the effectiveness of seasonal influenza vaccine in preventing Emergency Department (ED) visits and hospitalisations for influenza like illness (ILI) in children. Methods: We conducted a test negative case-control study during the 2011-2012 and 2012-2013 influenza seasons. Eleven paediatric hospital/wards in seven Italian regions participated in the study. Consecutive children visiting the ED with an ILI, as diagnosed by the doctor according to the European Centre for Disease Control case definition, were eligible for the study. Data were collected from trained pharmacists/physicians by interviewing parents during the ED visit (or hospital admission) of their children. An influenza microbiological test (RT-PCR) was carried out in all children. Results: Seven-hundred and four children, from 6 months to 16 years of age, were enrolled: 262 children tested positive for one of the influenza viruses (cases) and 442 tested negative (controls). Cases were older than controls (median age 46 vs. 29 months), though with a similar prevalence of chronic conditions. Only 25 children (4%) were vaccinated in the study period. The overall age-adjusted vaccine effectiveness (VE) was 38% (95% confidence interval -52% to 75%). A higher VE was estimated for hospitalised children (53%; 95% confidence interval -45% to 85%). Discussion: This study supports the effectiveness of the seasonal influenza vaccine in preventing visits to the EDs and hospitalisations for ILI in children, although the estimates were not statistically significant and with wide confidence intervals. Future systematic reviews of available data will provide more robust evidence for recommending influenza vaccination in children. © 2014 The Authors.

Published
2013

31. Botanical food supplements: regulatory framework

Author

DE IURI, Lucia, Scarpa, B., Dalfrà, S., Floridi, F., Baccari, S., Cesa, Stefania, Mannina, Luisa, Menniti Ippolito, F., and Casini, Antonio

Subjects
Botanical food supplements, Health claims, Surveillance system
Published
2013

39. A multicenter study on drug safety in children [Studio multicentrico sulla sicurezza dei farmaci in pediatria]

Author

Menniti-Ippolito, F., Da Cas, R., Bolli, M., Annalisa Capuano, Saglioca, L., Traversa, G., Messi, G., Marchetti, F., Lazzerini, M., Rovere, F., Tripaldi, E., Da Dalt, L., Bressan, E., Capretta, A., Falcon, E., Intini, F., Mongillo, B., Morando, C., Di Pietro, P., Rossi, R., Barbino, P., Bianchi, C., Renna, S., Dorozzi, N., Ceccheti, C., Iori, V., Lauri, M., Rauchi, U., Reale, A., Vetrano, F., Saggiamo, G., Giuliano, F. M., and Tipo, V.

Subjects
Hosptial admissions, Adverse drug reactions, Case-control study, Children
Published
2007

44. Mortalita' nei primi due anni di vita in Italia: Sudden Infant Death Syndrome e altre morti inattese

Author

Raschetti, R, Salmaso, S, Traversa, G, Bianchi, C, Caffari, B, Ciofi degli Atti, M, Fagiolo, L, Maggini, M, Menniti Ippolito, F, Pastore Celentano, L, Ruggeri, P, Spila Alegiani, S, Frova, L, Pappagallo, M, Santuccio, C, Severi, V, Montomoli, C, and SCALIA TOMBA, G

Subjects
SIDS, Infant mortality, SIDS, Infant mortality, Mortality studies, Mortality studies, Settore MAT/06 - Probabilita' e Statistica Matematica
Published
2005

47. Vaccine effectiveness against severe laboratory-confirmed influenza in children: results of two consecutive seasons in Italy.

Author

Mores, Nadia, Romagnoli, Costantino, Chiaretti, Antonio, Compagnone, Adele, Riccardi, Riccardo, Delogu, Giovanni, Sali, Michela, Menniti Ippolito, F, Da Cas, R, Traversa, G, Santuccio, C, Trotta, F, Felicetti, P, Tartaglia, L, Di Pietro, P, Barabino, P, Renna, S, Riceputi, L, Tovo, Pa, Gabiano, C, Baroero, L, Le Serre, D, Virano, S, Perilongo, G, Daverio, M, Gnoato, E, Maretti, M, Manuela, O, Galeazzo, B, Rubin, G, Scanferla, S, Da Dalt, L, Stefani, C, Zerbinati, C, Chiappini, E, Sollai, S, De Martino, M, Mannelli, F, Becciani, S, Giacalone, M, Montano, S, Remaschi, G, Stival, A, Furbetta, M, Abate, P, Leonardi, I, Pirozzi, N, Raucci, U, Reale, A, Rossi, R, Russo, C, Mancinelli, L, Carlo, C, Prete, V, Tipo, V, Dinardo, M, Auricchio, F, Polimeno, T., Mores, Nadia (ORCID:0000-0002-4197-0914), Romagnoli, Costantino (ORCID:0000-0003-1176-2943), Chiaretti, Antonio (ORCID:0000-0002-9971-1640), Riccardi, Riccardo (ORCID:0000-0001-7515-6622), Delogu, Giovanni (ORCID:0000-0003-0182-8267), Sali, Michela (ORCID:0000-0003-3609-2990), Mores, Nadia, Romagnoli, Costantino, Chiaretti, Antonio, Compagnone, Adele, Riccardi, Riccardo, Delogu, Giovanni, Sali, Michela, Menniti Ippolito, F, Da Cas, R, Traversa, G, Santuccio, C, Trotta, F, Felicetti, P, Tartaglia, L, Di Pietro, P, Barabino, P, Renna, S, Riceputi, L, Tovo, Pa, Gabiano, C, Baroero, L, Le Serre, D, Virano, S, Perilongo, G, Daverio, M, Gnoato, E, Maretti, M, Manuela, O, Galeazzo, B, Rubin, G, Scanferla, S, Da Dalt, L, Stefani, C, Zerbinati, C, Chiappini, E, Sollai, S, De Martino, M, Mannelli, F, Becciani, S, Giacalone, M, Montano, S, Remaschi, G, Stival, A, Furbetta, M, Abate, P, Leonardi, I, Pirozzi, N, Raucci, U, Reale, A, Rossi, R, Russo, C, Mancinelli, L, Carlo, C, Prete, V, Tipo, V, Dinardo, M, Auricchio, F, Polimeno, T., Mores, Nadia (ORCID:0000-0002-4197-0914), Romagnoli, Costantino (ORCID:0000-0003-1176-2943), Chiaretti, Antonio (ORCID:0000-0002-9971-1640), Riccardi, Riccardo (ORCID:0000-0001-7515-6622), Delogu, Giovanni (ORCID:0000-0003-0182-8267), and Sali, Michela (ORCID:0000-0003-3609-2990)

Abstract

OBJECTIVE: To evaluate the effectiveness of seasonal influenza vaccine in preventing Emergency Department (ED) visits and hospitalisations for influenza like illness (ILI) in children. METHODS: We conducted a test negative case-control study during the 2011-2012 and 2012-2013 influenza seasons. Eleven paediatric hospital/wards in seven Italian regions participated in the study. Consecutive children visiting the ED with an ILI, as diagnosed by the doctor according to the European Centre for Disease Control case definition, were eligible for the study. Data were collected from trained pharmacists/physicians by interviewing parents during the ED visit (or hospital admission) of their children. An influenza microbiological test (RT-PCR) was carried out in all children. RESULTS: Seven-hundred and four children, from 6 months to 16 years of age, were enrolled: 262 children tested positive for one of the influenza viruses (cases) and 442 tested negative (controls). Cases were older than controls (median age 46 vs. 29 months), though with a similar prevalence of chronic conditions. Only 25 children (4%) were vaccinated in the study period. The overall age-adjusted vaccine effectiveness (VE) was 38% (95% confidence interval -52% to 75%). A higher VE was estimated for hospitalised children (53%; 95% confidence interval -45% to 85%). DISCUSSION: This study supports the effectiveness of the seasonal influenza vaccine in preventing visits to the EDs and hospitalisations for ILI in children, although the estimates were not statistically significant and with wide confidence intervals. Future systematic reviews of available data will provide more robust evidence for recommending influenza vaccination in children.

Published
2014

48. Vaccine effectiveness against severe laboratory-confirmed influenza in children: results of two consecutive seasons in Italy

Author

Menniti Ippolito, F, Da Cas, R, Traversa, G, Santuccio, C, Felicetti, P, Tartaglia, L, Trotta, F, Di Pietro, P, Barabino, P, Renna, S, Riceputi, L, Tovo, P, Gabiano, C, Urbino, A, Baroero, L, Le Serre, D, Virano, S, Perilongo, G, Daverio, M, Gnoato, E, Maretti, M, Galeazzo, B, Rubin, G, Scanferla, S, Da Dalt, L, Stefani, C, Zerbinati, C, Chiappini, E, Sollai, S, De Martino, M, Mannelli, F, Becciani, S, Giacalone, M, Montano, S, Remaschi, G, Stival, A, Furbetta, M, Abate, P, Leonardi, I, Pirozzi, N, Raucci, U, Reale, A, Rossi, R, Russo, C, Mancinelli, L, Manuela, O, Carlo, C, Mores, Nadia, Romagnoli, C, Chiaretti, Antonio, Compagnone, A, Riccardi, Riccardo, Delogu, Giovanni, Sali, Michela, Prete, V, Tipo, V, Dinardo, M, Auricchio, F, Polimeno, T, Sodano, G, Maccariello, A, Rafaniello, C, Fucà, F, Di Rosa, E, Altavilla, D, Mecchio, A, Arrigo, T., Mores, Nadia (ORCID:0000-0002-4197-0914), Chiaretti, A (ORCID:0000-0002-9971-1640), Riccardi, Riccardo (ORCID:0000-0001-7515-6622), Delogu, Giovanni (ORCID:0000-0003-0182-8267), Sali, Michela (ORCID:0000-0003-3609-2990), Menniti Ippolito, F, Da Cas, R, Traversa, G, Santuccio, C, Felicetti, P, Tartaglia, L, Trotta, F, Di Pietro, P, Barabino, P, Renna, S, Riceputi, L, Tovo, P, Gabiano, C, Urbino, A, Baroero, L, Le Serre, D, Virano, S, Perilongo, G, Daverio, M, Gnoato, E, Maretti, M, Galeazzo, B, Rubin, G, Scanferla, S, Da Dalt, L, Stefani, C, Zerbinati, C, Chiappini, E, Sollai, S, De Martino, M, Mannelli, F, Becciani, S, Giacalone, M, Montano, S, Remaschi, G, Stival, A, Furbetta, M, Abate, P, Leonardi, I, Pirozzi, N, Raucci, U, Reale, A, Rossi, R, Russo, C, Mancinelli, L, Manuela, O, Carlo, C, Mores, Nadia, Romagnoli, C, Chiaretti, Antonio, Compagnone, A, Riccardi, Riccardo, Delogu, Giovanni, Sali, Michela, Prete, V, Tipo, V, Dinardo, M, Auricchio, F, Polimeno, T, Sodano, G, Maccariello, A, Rafaniello, C, Fucà, F, Di Rosa, E, Altavilla, D, Mecchio, A, Arrigo, T., Mores, Nadia (ORCID:0000-0002-4197-0914), Chiaretti, A (ORCID:0000-0002-9971-1640), Riccardi, Riccardo (ORCID:0000-0001-7515-6622), Delogu, Giovanni (ORCID:0000-0003-0182-8267), and Sali, Michela (ORCID:0000-0003-3609-2990)

Abstract

To evaluate the effectiveness of seasonal influenza vaccine in preventing Emergency Department (ED) visits and hospitalisations for influenza like illness (ILI) in children.

Published
2014

50. Stevens-johnson syndrome associated with drugs and vaccines in children: a case-control study

Author

Raucci, U, Rossi, R, Da Cas, R, Rafaniello, C, Mores, Nadia, Bersani, G, Reale, A, Pirozzi, N, Menniti Ippolito, F, Traversa, G., Mores, Nadia (ORCID:0000-0002-4197-0914), Raucci, U, Rossi, R, Da Cas, R, Rafaniello, C, Mores, Nadia, Bersani, G, Reale, A, Pirozzi, N, Menniti Ippolito, F, Traversa, G., and Mores, Nadia (ORCID:0000-0002-4197-0914)

Abstract

Stevens-Johnson Syndrome (SJS) is one of the most severe muco-cutaneous diseases and its occurrence is often attributed to drug use. The aim of the present study is to quantify the risk of SJS in association with drug and vaccine use in children.

Published
2013

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