Gastroenteritis From Rotavirus Infection in Brazilian Children Less Than 5 Years of Age (Study V260-031 AM1).
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| Tracking Information | |||||||||||||||||
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| First Received Date ICMJE | September 3, 2010 | ||||||||||||||||
| Last Updated Date | January 2, 2013 | ||||||||||||||||
| Start Date ICMJE | August 2010 | ||||||||||||||||
| Primary Completion Date | November 2011 (final data collection date for primary outcome measure) | ||||||||||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT01195844 on ClinicalTrials.gov Archive Site | ||||||||||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Descriptive Information | |||||||||||||||||
| Brief Title ICMJE | Gastroenteritis From Rotavirus Infection in Brazilian Children Less Than 5 Years of Age (Study V260-031 AM1). | ||||||||||||||||
| Official Title ICMJE | Rotavirus Gastroenteritis in Children Up to 5 Years of Age. Surveillance Performed in Hospitals From Four Brazilian Regions. | ||||||||||||||||
| Brief Summary | This is a 1-year study evaluating hospitalizations and the medical care for the treatment of diarrhea from rotavirus infection in children < 5 years of age, conducted in four hospitals located in four Brazilian regions. A stool sample from each eligible child passing 3 or more loose stools or watery stools within a period of 24 hours and requiring hospitalization or rehydration therapy (oral or IV rehydration) will be tested for the presence of rotavirus, using standard laboratory procedures (ie, Enzyme Linked Ligand Sorbent Assay, or ELlSA) by all participating hospitals. |
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| Detailed Description | Not Provided | ||||||||||||||||
| Study Type ICMJE | Observational | ||||||||||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||||||||||
| Biospecimen | Not Provided | ||||||||||||||||
| Sampling Method | Non-Probability Sample | ||||||||||||||||
| Study Population | Children less than 5 years of age from four Brazilian cities with diarrhea attributed to rotavirus infection. |
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| Condition ICMJE | Pediatric Gastroenteritis | ||||||||||||||||
| Intervention ICMJE | Biological: Rotavirus Vaccine
This is an observational study evaluating hospitalizations and the medical care for the treatment of diarrhea from rotavirus infection in children < 5 years of age; however, any rotavirus vaccines used in the children presenting with rotavirus-attributed diarrhea were evaluated, as well the prevalent rotavirus serotypes in this sample for future vaccine development. |
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| Study Group/Cohort (s) | Brazilian Children With Rotavirus Gastroenteritis
Brazilian children under 5 years of age who have diarrhea attributed to rotavirus located in 4 hospitals from 4 different Brazilian regions
Intervention: Biological: Rotavirus Vaccine |
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| Publications * | Not Provided | ||||||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||||||
| Recruitment Status ICMJE | Terminated | ||||||||||||||||
| Enrollment ICMJE | 230 | ||||||||||||||||
| Completion Date | November 2011 | ||||||||||||||||
| Primary Completion Date | November 2011 (final data collection date for primary outcome measure) | ||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||||||
| Ages | up to 5 Years | ||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||
| Location Countries ICMJE | Not Provided | ||||||||||||||||
| Administrative Information | |||||||||||||||||
| NCT Number ICMJE | NCT01195844 | ||||||||||||||||
| Other Study ID Numbers ICMJE | V260-031 | ||||||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||||||
| Responsible Party | Merck | ||||||||||||||||
| Study Sponsor ICMJE | Merck | ||||||||||||||||
| Collaborators ICMJE | Not Provided | ||||||||||||||||
| Investigators ICMJE |
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| Information Provided By | Merck | ||||||||||||||||
| Verification Date | January 2013 | ||||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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