Last updated: 02/21/2024 12:31:00

Study to analyze the clinical and cost impact of complete and incomplete Rotarix vaccination

GSK study ID
116830
See study documents
Clinicaltrials.gov ID
NCT01915888
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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
    Primary completion date:
    2015-25-11
    Observational study model:
    Cohort
    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:

      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.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Protocol
    Available language(s): English
    Download document(s)
    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    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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