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This study aims at collecting data to obtain baseline incidence and monitor trends over time in hospitalizations and deaths from all cause gastroenteritis in children <5 years of age, before and after implementation of Rotarix™ universal mass vaccination in Brazil.
In this study baseline gastroenteritis related hospital discharges and mortality data from the Ministry of Health databases (DATASUS) will be compared to the current data after introduction of Rotarix™.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gastroenteritis Cohort | All children suffering with gastroenteritis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Database analysis | Other | Review and collect data from database |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of all cause gastroenteritis related hospital discharges and deaths | In post vaccine introduction period compared to pre-vaccination period (gastroenteritis related hospital discharges from 1998 to 2010, gastroenteritis related deaths from 1990 to 2009) |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of all cause gastroenteritis related hospital discharges and hospital deaths by year, region and age groups | From 1998 to 2010 | |
| Occurrence of all cause gastroenteritis related deaths by year, region and age groups | From 1990 to 2009 |
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Inclusion Criteria:
Exclusion Criteria:
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All children <5 years of age being hospitalized due to gastroenteritis between 1998 and 2010 and deceased due to gastroenteritis between 1990 and 2009 in Brazil.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Belém | Pará | 66 090 000 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Lanzieri TM et al. The impact of rotavirus vaccination on gastroenteritis hospitalizations among children <5 years in Brazil. Abstract presented at the 6th World Congress of World Society for Pediatric Infectious Diseases (WSPID). Buenos Aires, Argentina, 18-22 November 2009. | ||
| 20300045 | Background | Lanzieri TM, Costa I, Shafi FA, Cunha MH, Ortega-Barria E, Linhares AC, Colindres RE. Trends in hospitalizations from all-cause gastroenteritis in children younger than 5 years of age in Brazil before and after human rotavirus vaccine introduction, 1998-2007. Pediatr Infect Dis J. 2010 Jul;29(7):673-5. doi: 10.1097/INF.0b013e3181da8f23. | |
| Background | Lanzieri TM et al. Impact of rotavirus vaccination on childhood diarrheal deaths in Brazil. Abstract presented at the 9th International Rotavirus Symposium (IRS). Johannesburg, South Africa, 2-3 August 2010. |
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| ID | Term |
|---|---|
| D003967 | Diarrhea |
| D005759 | Gastroenteritis |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005767 | Gastrointestinal Diseases |
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| D004066 | Digestive System Diseases |