Summary

Two new Rotavirus vaccines have recently been put on sale in Europe and Italy. It is necessary to know the characteristics and epidemiology of gastroenteritis in the various countries to be able to evaluate the vaccines’ impact. In Italy this data has not been studied before. 
Although these two vaccines have been proven safe, EMEA requested, as for all products, post-marketing surveillance, with particular attention to intussusception. To evaluate the possible impact of the vaccine on this pathology, it is essential to know the incidence of intussusception in the baseline population. 

Objectives:
-Measure the incidence of acute gastroenteritis episodes (AGE) in Italian children aged 0-10 years 
-Measure the incidence of intussusception (IS) in Italian children aged 0-10 years 
-Evaluate the presence of symptoms characteristic of rotavirus infection 
-Measure the risk in such a population of being hospitalized within one month of the episode 

Methods:
A retrospective cohort study was carried out on the PEDIANET database, which contains data on about 100,000 children distributed throughout Italy. 
96,180 children between the ages of 0 and 10 years, in follow-up by a paediatrician between September 2001 and September 2004 were studied. Potential cases of AGE and IS were identified according to diagnosis, hospitalisation and symptoms described in the clinical notes of the patient. All cases were individually validated. 
Possible events linked to AGE (hospitalisation, A&E attendances, specialist consultations) were examined in the 30 days following the first consultation. 
The number of ascertained cases of rotavirus was registered. The incidence was calculated with a 95% confidence interval. 

Results:
A total of 13978 cases of AGE and 21 cases intestinal obstruction including 10 cases of IS were identified. The incidence of AGE was 66.4/1000 person years (65.3-67.5). The incidence is similar in the two sexes and decreases rapidly with age (107/1000 person years between 0 and 1 year, 85.9/1000 between 2-4 years and 39.5/1000 between 5-10 years). 
The incidence of IS was 4.7/100,000 person years (2.4-8.4), 3.9/100,000 for females and 5.5/100,000 for males. The incidence of IS also decreases rapidly with age (14.8/100.000 person years between 0 and 1 year, 3.2/100.000 between 2 and 4 years, 1.9/100.000 between 5 and 10 years). 
29.1% of children with AGE had fever, 91% diarrhoea, 32.6% vomiting and 9.7% had all three. 
The risk of hospitalisation in the month following first presentation was 2.95% (2.7-3.2). In 1178 episodes of AGE (8.4%) faecal cultures were carried out, out of 302 results found, 58 (19.2%) were positive for rotavirus. Of the positive cases 56.9% were males, 34.5% had fever, 32.8% had vomiting and 13.8% both.

Partecipants and Collaborations

Coordinators

Luigi Cantarutti 
Coordinamento Pedianet, PLS, Padova 
Carlo Giaquinto 
Dipartimento di Pediatria, Padova 
Coordinamento Pedianet, PLS, Padova 
Montse Soriano-Gabarro 
Department of Epidemiology, Glaxo-Smith-Kline Biologicals, Rixensart, Belgio 
Miriam CJM Sturkenboom 
Department of Epidemiology and Buiostatistics and medical informatics, Erasmus University Medical Centre, Rotterdam 
Gino Picelli 
International Pharmacoepidemiology and pharmacoeconomics Research Centre, Italy

Partecipants

Abruzzo 
Bonfigli Emanuela, Collacciani Giuseppe, Ferretti Michele, Forcina Paolo. 

Campania 
Basile Paola, Bratto Massimo, Castaldo Annunziata, Conte Ugo Alfredo, Costanzo Nicola, Di Santo Giuseppe, Falco Pietro, Ferraiuolo Maurizio, Mariniello, Petrazzuoli Giovanni, Speranza Francesco, Sticco Maura, Tambaro Paolo. 

Emilia Romagna 
Alberti Arturo, Barone Roberto, Biondi Claudio, Casalboni Rita, Faedi Clara Maria, Hamameh Marwan, Lucchi Elide, Mazzini Franco, Ponti Roberto, Trebbi Miro, Varni Pierfiorenzo. 

Friuli Venezia Giulia 
De Clara Roberto, Lorusso Giuseppe, Masotti Sergio, Muzzolini Carmen, Nicolosio Flavia, Ulliana Antonella. 

Lombardia 
Battilana Maria Pia, Clerici Schoeller Mariangela, Curto Salvatore, Elio Giuseppe, Frattini Claudio, Lietti Giuseppe, Mauri Laura, Picco Patrizia, Pirola Ambrogina, Ragazzon Ferdinando, Rosignoli Rino, Russo Annarita, Terenghi Albino, Tusa Antonino, Vannini Paola, Vertua Guido. 

Marche 
Bollettini Stefano, Budassi Roberto, Dolci Marco, Galvagno Andrea, Gentili Alberta, Gentilucci Pierfrancesco, Gobbi Costantino, Grelloni Mauro, Olimpi Laura, Senesi Paolo, Tonelli Gabriele. 

Piemonte 
Mirabelli Maria Cristina, Sciolla Nico Maria, Valpreda Andrea. 

Sardegna 
Basoccu Pietro, Cera Giuseppe Egidio, Cuboni Giancarlo, Lazzari Maura, Mulas Anna, Rosas Paolo. 

Sicilia 
Alongi Angelo, Avarello Giovanni, Barberi Frandanisa Maria, Petrotto Giuseppe, Puma Antonino, Salamone Pietro, Speciale Sergio, Volpe Concetta. 

Toscana 
Storelli Francesco 

Veneto 
Barbieri Patrizia, Bucolo Carmelo, Cantarutti Luigi, Cozzani Sandra, D’Amanti Vito Francesco, De Marchi Annamaria, Doria Mattia, Drago Stefano, Ferrara Enrico, Fusco Fabrizio, Giancola Giuseppe, Girotto Silvia, Grillone Giuseppe, Katende Charles Mulopo, Lista Cinzia, Macropodio Nadia, Milano Massimo, Pasinato Angela, Passarella Andrea, Ruffato Bruno, Sambugaro Daniela, Saretta Luigi, Schievano Paolo, Semenzato Flavio, Spanevello Walter, Tamassia Gianni, Toffol Giacomo.

Collaborations

Data Monitor

Antonio Scamarcia 
Società Servizi Telematici, Padova

Computer-related Assistance

Alessandro Zandarin 
Società Servizi Telematici, Padova

Pubblications

Financing

The study was partially funded by GSK Biologicals, Rixensart, Belgium