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| Tracking Information | |||||||||
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| First Received Date ICMJE | April 29, 2008 | ||||||||
| Last Updated Date | February 18, 2009 | ||||||||
| Start Date ICMJE | May 2008 | ||||||||
| Estimated Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
patients' cost [ Time Frame: one year ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00669929 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Cost-Effectiveness Analysis of Rotavirus Vaccination for Children in Korea | ||||||||
| Official Title ICMJE | Cost-Effectiveness Analysis of Rotavirus Vaccination for Children in Korea | ||||||||
| Brief Summary | The primary objective of the proposed project is to estimate the economic impact of a national rotavirus immunization program in preventing rotavirus diarrhea among Korean children. |
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| Detailed Description | Rotavirus is the leading cause of severe acute diarrhea or gastroenteritis among young children worldwide. In the first 5 years of life, about 90% of children experience at least one episode of rotavirus infection.Each year, rotavirus diarrhea is responsible for 440,000 deaths, 2 million hospitalizations, and 25 million outpatient visits among children younger than 5 years worldwide. In South Korea, rotavirus diarrhea rarely causes mortality, but it cause significant morbidity. A recent population-based study in Korea has estimated that the annual incidence of rotavirus diarrhea accounts for 56.9 cases per 1,000 children less than 5 years old. Oral, live pentavalent human-bovine reassortant rotavirus vaccine has been developed and licensed for the use of preventing rotavirus disease in many countries. Yet, there has been no research done to assess the impact of national rotavirus immunization program in Korea. It is expected that systematic appraisal on the national burden of rotavirus infection and potential public health and economic benefits of rotavirus vaccination for children in Korea will assists health policy makers to set a priority for the prevention of this disease. |
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| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Cohort, Retrospective | ||||||||
| Condition ICMJE |
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| Intervention ICMJE | |||||||||
| 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 | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 200 | ||||||||
| Estimated Completion Date | June 2009 | ||||||||
| Estimated Primary Completion Date | June 2009 (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 |
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| Location Countries ICMJE | Korea, Republic of | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00669929 | ||||||||
| Responsible Party | Yonsei University Health System Severance Hospital, Yonsei University | ||||||||
| Study ID Numbers ICMJE | rota-001, yonsei-rota | ||||||||
| Study Sponsor ICMJE | Yonsei University | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Yonsei University | ||||||||
| Verification Date | February 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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