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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00653198 |
This study aims to estimate the effectiveness of Rotarix™ 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 Rotarix™ in the national immunization program.
Condition | Intervention |
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Rotavirus Severe Gastroenteritis |
Other: No intervention |
Study Type: | Observational |
Study Design: | Case Control, Prospective |
Official Title: | Hospital-Based, Case-Control Study to Assess the Vaccine Effectiveness of Rotarix™ Against Rotavirus Severe Gastroenteritis (RV SGE) Among Hospitalised Children Born After 1 March 2006 and at Least 12 Weeks of Age, in Panama |
Stool samples
Enrollment: | 263 |
Study Start Date: | March 2008 |
Study Completion Date: | March 2009 |
Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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B
Controls
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Other: No intervention
Not applicable
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A
Cases
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Other: No intervention
Not applicable
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Ages Eligible for Study: | 12 Weeks and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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.
Inclusion Criteria for enrolled subjects and cases :
Inclusion criteria for controls:
Exclusion Criteria for enrolled subjects and cases:
Exclusion criteria for controls:
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 104676 |
Study First Received: | March 19, 2008 |
Last Updated: | May 21, 2009 |
ClinicalTrials.gov Identifier: | NCT00653198 History of Changes |
Health Authority: | Panama: Ministry of Health |
Rotavirus severe gastroenteritis (RV SGE) |
Digestive System Diseases Gastrointestinal Diseases Gastroenteritis |
Digestive System Diseases Gastrointestinal Diseases Gastroenteritis |