Study to Analyze the Clinical and Cost Impact of Complete and Incomplete Rotarix Vaccination

Infections, Rotavirus Clinical Trial

Official title:

Clinical and Cost Impact of Complete and Incomplete Rotarix Vaccination

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01915888
• Other study ID #: 116830
• Status: Completed
• Phase: N/A
• First received: July 25, 2013
• Last updated: November 13, 2014
• Start date: August 2013
• Est. completion date: February 2014

Study information

• Verified date: November 2014
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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).

Description:

Insurance claims data from the MarketScan Commercial Claims and Encounters Database {MarketScan Commercial (2000-2010)} and the MarketScan Multi-State Medicaid Database {MarketScan Medicaid (2002-2009)} will be analyzed separately; no merging of the databases will occur.

The claims data extracts are fully de-identified and compliant with the Health Insurance Portability and Accountability Act of 1996 (U.S.) (HIPAA).

The children will be observed from birth to the earliest of end of continuous eligibility (due to disenrollment, data cut-off, or death) or 5 years of age. Observation time will be classified using two different definitions of Rotarix vaccination coverage, and analyses will be conducted for each different scenario.

The two definitions for Rotarix vaccination coverage are:

1. Rotarix vaccination according to compliance with the Advisory Committee on Immunization Practices (ACIP)-specified vaccination window of 6 weeks to 8 months old.

2. Rotarix vaccination according to compliance with the Rotarix prescribing information (PI) window of 6 weeks to 6 months old.

All outcomes will be analysed for 1) vaccination coverage according to compliance with the ACIP vaccination window, and 2) vaccination coverage according to compliance with PI vaccination window; for both Rotarix vaccination coverage scenarios there will be four cohorts.

An additional 'complete Rotarix vaccination off-ACIP/off-PI' cohort will be created if more than 5 percent of total person-time in the four cohorts would be complete vaccination if vaccine doses outside of the vaccination window were considered.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• 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).

• Received any Rotateq vaccination.

• Lost to follow-up prior to end of vaccination window or had RV prior to end of vaccination window.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Infections, Rotavirus
• Rotavirus Infections

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
GlaxoSmithKline	Analysis Group, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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)	No
Primary	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)	No