Infections, Rotavirus Clinical Trial
Official title:
Clinical and Cost Impact of Complete and Incomplete Rotarix Vaccination
Verified date | November 2014 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Observational |
This study aims to estimate the clinical and cost impact of Rotarix vaccinations among children aged less than 5 years using insurance claims data from commercial plans and Medicaid low-income population. The impact of incomplete and complete Rotarix vaccination will also be examined, overall and stratified by calendar time of Rotarix vaccination (e.g., 2008 onward).
Status | Completed |
Enrollment | 1 |
Est. completion date | February 2014 |
Est. primary completion date | February 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | N/A to 5 Years |
Eligibility |
Inclusion Criteria: - Continuously enrolled from birth. (Note: Due to the absence of birth dates in insurance claims data, this inclusion criterion will be met if a child's year of first enrollment and year of birth are the same. If so, then the date of first enrollment will be used as proxy for date of birth.) - Received both medical and pharmacy benefits. Exclusion Criteria: - Enrolled in capitation-based health plans. - For MarketScan Commercial, residence in states with universal vaccination programs that include the RV vaccine or where RV vaccine inclusion cannot be ascertained (i.e., Alaska, Idaho, Massachusetts, Maine, North Dakota, New Hampshire, New Mexico, Oregon, Rhode Island, Vermont, Washington, Wisconsin, and Wyoming). - Received any Rotateq vaccination. - Lost to follow-up prior to end of vaccination window or had RV prior to end of vaccination window. |
Observational Model: Cohort, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline | Analysis Group, Inc. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of first RV episode | Estimation and comparison of the clinical impact of complete and incomplete Rotarix vaccination among children less than 5 years of age | During the study period (from 2000 up to 2010) | No |
Primary | Incidence of RV-related utilization | Estimation and comparison of the clinical impact of complete and incomplete Rotarix vaccination among children less than 5 years of age | During the study period (from 2000 up to 2010) | No |
Primary | Incidence of diarrhea-related utilization | Estimation and comparison of the clinical impact of complete and incomplete Rotarix vaccination among children less than 5 years of age | During the study period (from 2000 up to 2010) | No |
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