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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | March 19, 2008 | ||||
| Last Updated Date | May 21, 2009 | ||||
| Start Date ICMJE | March 2008 | ||||
| Primary Completion Date | March 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
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. | ||||
| Change History | Complete list of historical versions of study NCT00653198 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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. [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
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. | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effectiveness of Rotarix™ Against Rotavirus Severe Gastroenteritis (RV SGE) in Infants in Panama | ||||
| Official Title ICMJE | 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 | ||||
| Brief Summary | 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. |
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| Detailed Description | |||||
| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Condition ICMJE | Rotavirus Severe Gastroenteritis | ||||
| Intervention ICMJE | Other: No intervention
Not applicable
Other Name: No intervention |
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| Study Arms / Comparison Groups |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 263 | ||||
| Completion Date | March 2009 | ||||
| Primary Completion Date | March 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | 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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| Gender | Both | ||||
| Ages | 12 Weeks and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Panama | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00653198 | ||||
| Responsible Party | Study Director, GSK | ||||
| Study ID Numbers ICMJE | 104676 | ||||
| Study Sponsor ICMJE | GlaxoSmithKline | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | GlaxoSmithKline | ||||
| Verification Date | May 2009 | ||||
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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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