Infections, Rotavirus Clinical Trial
Official title:
Clinical and Cost Impact of Complete and Incomplete Rotavirus Vaccination
Verified date | August 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 RV vaccinations (both Rotateq® and Rotarix®) 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 RV vaccination will also be examined, overall and stratified by age (e.g., 6 weeks to 8 months, 8 months and onwards ) and calendar time of RV vaccination (e.g., 2006 onward).
Status | Completed |
Enrollment | 1 |
Est. completion date | August 2013 |
Est. primary completion date | August 2013 |
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). - Lost to follow-up or had RV prior to 6 weeks of age. |
Observational Model: Cohort, Time Perspective: Retrospective
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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GlaxoSmithKline |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Estimation of the clinical impact of complete and incomplete RV vaccination among children less than 5 years of age by determining the incidence of first RV episode. | Each RV episode will last from 14 days before the first RV-coded claim to 14 days after the last RV-coded claim, unless censored by birth at the start and/or by end of observation at the end. For each cohort, incidence rates will be calculated as the number of first RV episodes that occurred divided by the cohort's person-years of observation censored at the start of first RV episodes. | During the study period (from January 2000 up to June 2011), an expected average of 1 year and 6 months. | No |
Primary | Estimation of the clinical impact of complete and incomplete RV vaccination among children less than 5 years of age by calculating the RV-related resource utilization. | For each cohort, utilization rates will be calculated as the number of RV-related hospitalizations, ER visits, and outpatient visits utilized divided by the cohort's total person-years of observation. | During the study period (from January 2000 up to June 2011), an expected average of 1 year and 6 months. | No |
Primary | Estimation of the clinical impact of complete and incomplete RV vaccination among children less than 5 years of age by calculating the diarrhea-related resource utilization. | For each cohort, utilization rates will be calculated as the number of diarrhea-related hospitalizations, ER visits, and outpatient visits utilized divided by the cohort's total person-years of observation. | During the study period (from January 2000 up to June 2011), an expected average of 1 year and 6 months. | No |
Primary | Estimation of the cost impact of complete and incomplete RV vaccination among children less than 5 years of age by determining the first RV episode costs. | Costs will be reported on a per-patient per-month (PPPM) basis, using the episode duration in person-months as the weight. For each cohort, an average PPPM cost of first RV episodes will be calculated. | During the study period (from January 2000 up to June 2011), an expected average of 1 year and 6 months. | No |
Primary | Estimation of the cost impact of complete and incomplete RV vaccination among children less than 5 years of age by calculating the RV-related healthcare costs. | For each cohort, total RV-related per-patient per-year (PPPY) costs will be calculated as the total cost of RV-related hospitalizations, ER visits, and outpatient visits utilized divided by the cohort's total person-years of observation. | During the study period (from January 2000 up to June 2011), an expected average of 1 year and 6 months. | No |
Primary | Estimation of the cost impact of complete and incomplete RV vaccination among children less than 5 years of age by calculating the diarrhea-related healthcare costs. | For each cohort, total diarrhea-related PPPY costs will be calculated as the total cost of diarrhea-related hospitalizations, ER visits, and outpatient visits utilized divided by the cohort's total person-years of observation. | During the study period (from January 2000 up to June 2011), an expected average of 1 year and 6 months. | No |
Primary | Estimation of the clinical impact of complete and incomplete RV vaccination among children less than 5 years of age by calculating the first diarrhea episode costs. | During the study period (from 2000 up to June 2011). | No |
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