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Mohamed Khalil,1 Esam Azhar,2,3 Moujahed Kao,3 Noura Al-Kaiedi,3 Hatim Alhani,4 Ibrahim Al Olayan,5 Robert Pawinski,6,7 Kusuma Gopala,8 Walid Kandeil,7 Sameh Anis,7,9 Leen Jan Van Doorn,10 Rodrigo DeAntonio7 1Public Health and Research Development, Ministry of Health, Riyadh, Saudi Arabia; 2Medical Laboratory Technology Department, Faculty of Applied Medical Sciences, 3Special Infectious Agents Unit, Bio-Safety Level 3, King Fahad Medical Research Center, King Abdulaziz University, Jeddah, Saudi Arabia; 4Maternity and Children’s Hospital, Dammam, Saudi Arabia; 5Maternity and Children’s Hospital, Qassim, Saudi Arabia; 6Reckitt Benckiser Pharmaceuticals, Slough, UK; 7GlaxoSmithKline Vaccines, Wavre, Belgium; 8GlaxoSmithKline Pharmaceuticals Ltd, Bangalore, Karnataka, India; 9AbbVie Biopharmaceuticals GmbH, Dubai, United Arab Emirates; 10DDL Diagnostic Laboratory, Rijswijk, the Netherlands Purpose: Rotavirus (RV) is a leading cause of severe gastroenteritis (GE) in children across the world. As there is a lack of epidemiological data for RV gastroenteritis (RVGE) in Saudi Arabia, this hospital-based study was designed to estimate the disease burden of RVGE and assess the prevalent RV types in Saudi children younger than 5 years of age.Patients and methods: Children hospitalized for acute GE were enrolled at four pediatric referral hospitals in Saudi Arabia. The study was conducted from February 2007 to March 2008 and used the World Health Organization's generic protocol for RVGE surveillance. The Vesikari severity scale was used to assess the severity of RVGE. Stool samples were tested for RV using an enzyme-linked immunosorbent assay. Samples were further typed by reverse transcriptase–polymerase chain reaction and hybridization assay for determining the G and P types.Results: A total of 1,007 children were enrolled; the final analysis included 970 children, of whom 395 were RV positive, 568 were RV negative, and seven had unknown RV status. The proportion of RVGE among GE hospitalizations was 40.7% (95% confidence interval: 37.6–43.9). The highest percentage of RVGE hospitalizations (83.1%) was seen in children younger than 2 years of age. The highest proportion of RV among GE hospitalizations was in June 2007 with 57.1%. The most common RV types detected were G1P[8] (49.3%), G1G9P[8] (13.2%), and G9P[8] (9.6%). Before hospitalization, severe GE episodes occurred in 88.1% RV-positive and 79.6% RV-negative children. Overall, 94% children had recovered by the time they were discharged. Two children (one RV positive and one RV negative) died due to GE complications.Conclusion: RVGE is responsible for a high proportion of hospitalizations in Saudi children younger than 5 years of age. Routine RV vaccination has therefore been introduced into the national immunization program and may help reduce the morbidity, mortality, and disease burden associated with RVGE in Saudi Arabia. Keywords: disease burden, Saudi Arabia, rotavirus, RVGE, epidemiology