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This study aims to estimate the effectiveness of Rotarixâ„¢ vaccine which is used nationwide as a part of the expanded program on immunization (EPI), in preventing RV SGE among hospitalised children born after 1 March 2006, which corresponds to the date of introduction of Rotarixâ„¢ in the national immunization program.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Cases |
| |
| B | Controls |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of RV GE among children born after 1 March 2006, at least 12 weeks of age and admitted to the study hospital for SGE. |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of acute GE among children born after 1 March 2006, at least 12 weeks of age and admitted to the study hospital for SGE. |
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Inclusion Criteria for enrolled subjects and cases :
Inclusion criteria for controls:
Exclusion Criteria for enrolled subjects and cases:
Exclusion criteria for controls:
OR
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Cases will include those children born after 1 March 2006, at least 12 weeks of age and hospitalised for RV SGE in the study hospital, during the designated study period. For each case, three hospital controls and three neighbourhood controls will be included in the study, after matching by date of birth. Hospital controls will be children hospitalised for non-GE causes in the study hospital during the same time period as the case. Neighbourhood controls will be children without any symptoms of GE or SGE, and residing in the same area as the case at least for three consecutive months.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Panama City | Panama |
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| ID | Term |
|---|---|
| D012400 | Rotavirus Infections |
| ID | Term |
|---|---|
| D012088 | Reoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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Stool samples