Last updated: 02/21/2024 12:31:00
Study to analyze the clinical and cost impact of complete and incomplete Rotarix vaccination
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Clinical and cost impact of complete and incomplete Rotarix vaccination
Trial description: 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).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Incidence of first RV episode
Timeframe: During the study period (from 2000 up to 2010)
Incidence of RV-related utilization
Timeframe: During the study period (from 2000 up to 2010)
Incidence of diarrhea-related utilization
Timeframe: During the study period (from 2000 up to 2010)
Secondary outcomes:
Not applicable
Interventions:
Other: Data interpretation
Enrollment:
1
Observational study model:
Cohort
Primary completion date:
2015-25-11
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Infections, Rotavirus
Product
SB444563
Collaborators
Analysis Group, Inc
Study date(s)
August 2013 to November 2015
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
Not applicable - 5 years
Accepts healthy volunteers
Yes
- 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.)
- 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).
Inclusion and exclusion criteria
Inclusion criteria:
- Received both medical and pharmacy benefits.
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.)
Exclusion criteria:
- 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.
Enrolled in capitation-based health plans.
Trial location(s)
No location data available.
Study documents
Protocol
Available language(s): English
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
2015-25-11
Actual study completion date
2015-25-11
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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