Study to Analyze the Clinical and Cost Impact of Complete and Incomplete Rotavirus (RV) Vaccination

NCT ID: NCT01682005

Last Updated: 2014-09-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2013-08-31

Brief Summary

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).

Detailed Description

Insurance claims data from the MarketScan Commercial Claims and Encounters Database {MarketScan Commercial (2000-2011[Q2])} and the MarketScan Multi-State Medicaid Database {Marketscan Medicaid (2002-2010)} 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).

For children who received at least 1 RV vaccine dose within the Advisory Committee on Immunization Practices (ACIP)-specified vaccination window of 6 weeks to 8 months old, their observation time will be divided into three RV-vaccinated cohorts: any RV vaccination before 8 months (i.e., during the vaccination window between 6 weeks and 8 months old); complete RV vaccination (i.e., after 8 months old); and incomplete RV vaccination (i.e., after 8 months old). For children who did not receive any RV vaccine dose within the vaccination window, their observation time will be divided into four control cohorts: historical (i.e., before RV vaccines were available) unvaccinated on/before 8 months old; contemporary (i.e., after RV vaccines were available) unvaccinated on/before 8 months old; historical unvaccinated after 8 months old; and contemporary unvaccinated after 8 months old.

Conditions

Infections, Rotavirus

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Complete RV vaccination

Subjects had received 2 doses of Rotarix or 3 doses of Rotateq/mixed within the vaccination window and the observation time is from the end of the vaccination window (8 months old) to end of observation.

Data interpretation

Intervention Type: OTHER

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

Incomplete RV vaccination

Subjects received at least one vaccination but less than complete vaccination has been received within the vaccination window and the observation time from 8 months old (if still observed) to end of observation.

Data interpretation

Intervention Type: OTHER

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

Any RV vaccination before 8 months

Subjects received any vaccination within the vaccination window and the observation time from 6 weeks old to earliest of end of observation or 8 months old.

Data interpretation

Intervention Type: OTHER

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

Historical unvaccinated on/before 8 months old

Subjects did not receive any RV vaccination within the vaccination window and the observation time is from 6 weeks old (if still observed and on/before 12/31/06) to earliest of: 12/31/2006, end of observation, or 8 months old.

Data interpretation

Intervention Type: OTHER

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

Historical unvaccinated after 8 months old

Subjects did not receive any RV vaccination within the vaccination window and observation time is from 8 months old (if still observed and on/before 12/31/2006) to earliest of: 12/31/2006 or end of observation.

Data interpretation

Intervention Type: OTHER

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

Contemporary unvaccinated on/before 8 months old

Subjects did not receive any RV vaccination within the vaccination window and observation time is from 6 weeks old (if on/after 01/01/2007) to earliest of: end of observation, or 8 months old.

Data interpretation

Intervention Type: OTHER

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

Contemporary unvaccinated after 8 months old

Subjects did not receive any RV vaccination within the vaccination window observation time is from 8 months old (if on/after 01/01/2007) to end of observation.

Data interpretation

Intervention Type: OTHER

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

Interventions

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).

Intervention Type: OTHER

Eligibility 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.

• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

References

Krishnarajah G, Duh MS, Korves C, Demissie K. Public Health Impact of Complete and Incomplete Rotavirus Vaccination among Commercially and Medicaid Insured Children in the United States. PLoS One. 2016 Jan 11;11(1):e0145977. doi: 10.1371/journal.pone.0145977. eCollection 2016.

Reference Type: DERIVED

PMID: 26751375 (View on PubMed)

Other Identifiers

116829

Identifier Type: -

Identifier Source: org_study_id