NCT01915888

Brief Summary

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2013

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2013

Completed
7 days until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

November 17, 2014

Status Verified

November 1, 2014

Enrollment Period

6 months

First QC Date

July 25, 2013

Last Update Submit

November 13, 2014

Conditions

Infections, Rotavirus

Keywords

ClinicalChildrenRotavirusCostRotarix vaccination

Outcome Measures

Primary Outcomes (3)

  • 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)

  • 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)

  • 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)

Study Arms (4)

Complete Rotarix vaccination cohort

Subjects had received 2 doses of Rotarix within the vaccination window and the observation time is from the end of the vaccination window (8 months old for ACIP scenario, or 6 months old for PI scenario) to end of observation.

Other: Data interpretation

Incomplete Rotarix vaccination cohort

Subjects had received one vaccination of Rotarix within the vaccination window and the observation time is from end of vaccination window (8 months old for ACIP scenario, or 6 months old for PI scenario)(if still observed) to end of observation.

Other: Data interpretation

Historical unvaccinated cohort

Subjects did not receive any Rotarix vaccine dose within the vaccination window and the observation time is from end of the vaccination window (8 months old for ACIP scenario, or 6 months old for PI scenario, if vaccination window ends on/before 12/31/2006) to end of observation.

Other: Data interpretation

Contemporary unvaccinated cohort

Subjects did not receive any Rotarix vaccine dose within the vaccination window and the observation time is from end of the vaccination window (8 months old for ACIP scenario, or 6 months old for PI scenario, if vaccination window ends after 1/1/2007) to end of observation.

Other: Data interpretation

Interventions

Data interpretationOTHER

The data collected for each group will be fully de-identified, interpreted and analysed separately for the 2 databases (MarketScan Commercial and MarketScan Medicaid).

Complete Rotarix vaccination cohortContemporary unvaccinated cohortHistorical unvaccinated cohortIncomplete Rotarix vaccination cohort

Eligibility Criteria

AgeUp to 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Children less than 5 years old continuously enrolled in commercial insurance or Medicaid from birth, and received both medical and pharmacy benefits.

You may qualify if:

  • Received both medical and pharmacy benefits.

You may not qualify if:

  • Enrolled in capitation-based health plans.
  • Received any Rotateq vaccination.
  • Lost to follow-up prior to end of vaccination window or had RV prior to end of vaccination window.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Krishnarajah G, Kageleiry A, Korves C, Lefebvre P, Duh MS. Public health impact of Rotarix vaccination among commercially insured children in the United States. Vaccine. 2017 Sep 5;35(37):5065-5072. doi: 10.1016/j.vaccine.2017.06.034. Epub 2017 Aug 1.

    PMID: 28778611DERIVED

MeSH Terms

Conditions

Rotavirus Infections

Interventions

Data Interpretation, Statistical

Condition Hierarchy (Ancestors)

Reoviridae InfectionsRNA Virus InfectionsVirus DiseasesInfections

Intervention Hierarchy (Ancestors)

Decision Support TechniquesInvestigative TechniquesStatistics as TopicEpidemiologic MethodsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2013

First Posted

August 5, 2013

Study Start

August 1, 2013

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

November 17, 2014

Record last verified: 2014-11