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      Hospitalisation for rotavirus gastroenteritis in the paediatric population in the Veneto Region, Italy

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          Abstract

          Background

          This study evaluates the epidemiological impact of RVGE hospitalisation in the Veneto Region during the period spanning from 2000-2007 along with the associated costs. The analysis was conducted in an area where rotavirus vaccination is not included into immunization programmes and is an attempt to assess the potential benefits of such introduction.

          Methods

          To update the estimates of acute RVGE hospitalisation rates in children ≤5 years in the Veneto Region, we conducted an 8 year retrospective observational population-based analysis (2000-2007).

          Results

          Over the study period, a total of 4,119 admissions for RVGE were reported, with a mean hospital stay of 3.5 days. The population-based hospitalisation RVGE incidence rate was 195.8 per 100,000 children aged ≤5 years (lower than other European countries).

          Conclusions

          RVGE is an important cause of paediatric hospitalisation in the Veneto Region. The data reaffirm the substantial burden of rotavirus hospitalisations in children and the potential health benefits of the vaccination as well as the possibility of adding rotavirus vaccination to the current schedule.

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          Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis.

          Guillermo Ruiz-Palacios, Irene Pérez-Schael, F Velázquez … (2006)
          The safety and efficacy of an attenuated G1P[8] human rotavirus (HRV) vaccine were tested in a randomized, double-blind, phase 3 trial. We studied 63,225 healthy infants from 11 Latin American countries and Finland who received two oral doses of either the HRV vaccine (31,673 infants) or placebo (31,552 infants) at approximately two months and four months of age. Severe gastroenteritis episodes were identified by active surveillance. The severity of disease was graded with the use of the 20-point Vesikari scale. Vaccine efficacy was evaluated in a subgroup of 20,169 infants (10,159 vaccinees and 10,010 placebo recipients). The efficacy of the vaccine against severe rotavirus gastroenteritis and against rotavirus-associated hospitalization was 85 percent (P<0.001 for the comparison with placebo) and reached 100 percent against more severe rotavirus gastroenteritis. Hospitalization for diarrhea of any cause was reduced by 42 percent (95 percent confidence interval, 29 to 53 percent; P<0.001). During the 31-day window after each dose, six vaccine recipients and seven placebo recipients had definite intussusception (difference in risk, -0.32 per 10,000 infants; 95 percent confidence interval, -2.91 to 2.18; P=0.78). Two oral doses of the live attenuated G1P[8] HRV vaccine were highly efficacious in protecting infants against severe rotavirus gastroenteritis, significantly reduced the rate of severe gastroenteritis from any cause, and were not associated with an increased risk of intussusception. (ClinicalTrials.gov numbers, NCT00139347 and NCT00263666.) Copyright 2006 Massachusetts Medical Society.
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            Safety and efficacy of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine.

            Timo Vesikari, David Matson, Penelope H Dennehy … (2006)
            Rotavirus is a leading cause of childhood gastroenteritis and death worldwide. We studied healthy infants approximately 6 to 12 weeks old who were randomly assigned to receive three oral doses of live pentavalent human-bovine (WC3 strain) reassortant rotavirus vaccine containing human serotypes G1, G2, G3, G4, and P[8] or placebo at 4-to-10-week intervals in a blinded fashion. Active surveillance was used to identify subjects with serious adverse and other events. The 34,035 infants in the vaccine group and 34,003 in the placebo group were monitored for serious adverse events. Intussusception occurred in 12 vaccine recipients and 15 placebo recipients within one year after the first dose including six vaccine recipients and five placebo recipients within 42 days after any dose (relative risk, 1.6; 95 percent confidence interval, 0.4 to 6.4). The vaccine reduced hospitalizations and emergency department visits related to G1-G4 rotavirus gastroenteritis occurring 14 or more days after the third dose by 94.5 percent (95 percent confidence interval, 91.2 to 96.6 percent). In a nested substudy, efficacy against any G1-G4 rotavirus gastroenteritis through the first full rotavirus season after vaccination was 74.0 percent (95 percent confidence interval, 66.8 to 79.9 percent); efficacy against severe gastroenteritis was 98.0 percent (95 percent confidence interval, 88.3 to 100 percent). The vaccine reduced clinic visits for G1-G4 rotavirus gastroenteritis by 86.0 percent (95 percent confidence interval, 73.9 to 92.5 percent). This vaccine was efficacious in preventing rotavirus gastroenteritis, decreasing severe disease and health care contacts. The risk of intussusception was similar in vaccine and placebo recipients. (ClinicalTrials.gov number, NCT00090233.) Copyright 2006 Massachusetts Medical Society.
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              Global Illness and Deaths Caused by Rotavirus Disease in Children

              Umesh D Parashar, Erik Hummelman, Joseph Bresee … (2003)
              To estimate the global illness and deaths caused by rotavirus disease, we reviewed studies published from 1986 to 2000 on deaths caused by diarrhea and on rotavirus infections in children. We assessed rotavirus-associated illness in three clinical settings (mild cases requiring home care alone, moderate cases requiring a clinic visit, and severe cases requiring hospitalization) and death rates in countries in different World Bank income groups. Each year, rotavirus causes approximately 111 million episodes of gastroenteritis requiring only home care, 25 million clinic visits, 2 million hospitalizations, and 352,000–592,000 deaths (median, 440,000 deaths) in children <5 years of age. By age 5, nearly every child will have an episode of rotavirus gastroenteritis, 1 in 5 will visit a clinic, 1 in 60 will be hospitalized, and approximately 1 in 293 will die. Children in the poorest countries account for 82% of rotavirus deaths. The tremendous incidence of rotavirus disease underscores the urgent need for interventions, such as vaccines, to prevent childhood deaths in developing nations.
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                Author and article information

                Journal
                Journal ID (nlm-ta): BMC Public Health
                Title: BMC Public Health
                Publisher: BioMed Central
                ISSN (Electronic): 1471-2458
                Publication date Collection: 2010
                Publication date (Electronic): 22 October 2010
                Volume: 10
                Page: 636
                Affiliations
                [1 ]Hospital Services, the Veneto Region, Rio Novo, Italy
                [2 ]Department of Environmental Medicine and Public Health, Institute of Hygiene, University of Padua, Italy
                [3 ]Medical Directorate, Asolo Local Health Unit, Italy
                [4 ]Regional Health Services Directorate, the Veneto Region, Rio Novo, Italy
                Article
                Publisher ID: 1471-2458-10-636
                DOI: 10.1186/1471-2458-10-636
                PMC ID: 2978151
                PubMed ID: 20969755
                SO-VID: 93430f99-6ae6-42bf-ae14-ca3fae81e51f
                Copyright © Copyright ©2010 Saia et al; licensee BioMed Central Ltd.
                License:

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                Date received : 2 April 2010
                Date accepted : 22 October 2010
                Categories
                Subject: Research Article

                ScienceOpen disciplines: Public health
                Data availability:
                ScienceOpen disciplines: Public health

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