Last updated: 11/07/2018 11:03:46

Study to analyze the clinical and cost impact of complete and incomplete rotavirus (RV) vaccination

GSK study ID
116829
See study documents
Clinicaltrials.gov ID
NCT01682005
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 rotavirus vaccination
Trial description: 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).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

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.

Timeframe: During the study period (from January 2000 up to June 2011), an expected average of 1 year and 6 months.

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.

Timeframe: During the study period (from January 2000 up to June 2011), an expected average of 1 year and 6 months.

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.

Timeframe: During the study period (from January 2000 up to June 2011), an expected average of 1 year and 6 months.

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.

Timeframe: During the study period (from January 2000 up to June 2011), an expected average of 1 year and 6 months.

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.

Timeframe: During the study period (from January 2000 up to June 2011), an expected average of 1 year and 6 months.

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.

Timeframe: During the study period (from January 2000 up to June 2011), an expected average of 1 year and 6 months.

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.

Timeframe: During the study period (from 2000 up to June 2011).

Secondary outcomes:
Not applicable
Interventions:
  • Other: Data interpretation
    • Enrollment:
    1
    Primary completion date:
    Not applicable
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Krishnarajah G et al. (2016) Public health impact of complete and incomplete rotavirus vaccination among commercially and Medicaid insured children in the United States. PLoS One. 11(1);e0145977.
    Medical condition
    Infections, Rotavirus
    Product
    SB444563
    Collaborators
    Not applicable
    Study date(s)
    August 2012 to August 2013
    Type
    Observational
    Phase
    Not applicable

    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).
      • Lost to follow-up or had RV prior to 6 weeks of age.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)
    Protocol
    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
    Not applicable
    Actual study completion date
    2013-23-08

    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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