Effectiveness of Rotavirus Immunization in Nicaragua
| Tracking Information | |||||
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| First Received Date ICMJE | May 27, 2010 | ||||
| Last Updated Date | September 8, 2011 | ||||
| Start Date ICMJE | January 2010 | ||||
| Primary Completion Date | January 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT01133808 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 | Effectiveness of Rotavirus Immunization in Nicaragua | ||||
| Official Title ICMJE | Effectiveness of Rotavirus Immunization at the Community Level in Nicaragua | ||||
| Brief Summary | The purpose of the investigators study is to compare the rates of childhood diarrhea at the community level before and after the rotavirus vaccination program in León, Nicaragua. From preliminary studies, the investigators anticipate about a 28% reduction in diarrhea following the vaccination program among children who received the vaccine, and a smaller reduction in diarrhea among children who did not receive the vaccine, due to the effects of "herd immunity". In addition, the investigators will collect stool samples from children who develop diarrhea in order determine the etiology of childhood diarrhea in the post-rotavirus immunization era. |
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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 | Retention: Samples Without DNA Description: Stool samples obtained from children who develop diarrhea during the course of the study. In addition, stool samples will also be collected from normal children to serve as controls in laboratory analysis. |
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| Sampling Method | Probability Sample | ||||
| Study Population | Children under age 5 in Leon, Nicaragua |
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| Condition ICMJE | Diarrhea | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| 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 | Completed | ||||
| Enrollment ICMJE | 667 | ||||
| Completion Date | January 2011 | ||||
| Primary Completion Date | January 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 | NCT01133808 | ||||
| Other Study ID Numbers ICMJE | 09-0371, K01TW008401-01 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Sylvia Becker-Dreps, University of North Carolina, Chapel Hill | ||||
| Study Sponsor ICMJE | Sylvia Becker-Dreps | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | University of North Carolina, Chapel Hill | ||||
| Verification Date | September 2011 | ||||
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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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