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

August 28, 2014 updated by: GlaxoSmithKline

Clinical and Cost Impact of Complete and Incomplete Rotavirus Vaccination

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability 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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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).
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.
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).
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.
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).
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.
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).
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.
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).
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.
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).
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.
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Time Frame: During the study period (from January 2000 up to June 2011), an expected average of 1 year and 6 months.
Each RV episode will last from 14 days before the first RV-coded claim to 14 days after the last RV-coded claim, unless censored by birth at the start and/or by end of observation at the end. For each cohort, incidence rates will be calculated as the number of first RV episodes that occurred divided by the cohort's person-years of observation censored at the start of first RV episodes.
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.
Time Frame: During the study period (from January 2000 up to June 2011), an expected average of 1 year and 6 months.
For each cohort, utilization rates will be calculated as the number of RV-related hospitalizations, ER visits, and outpatient visits utilized divided by the cohort's total person-years of observation.
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.
Time Frame: During the study period (from January 2000 up to June 2011), an expected average of 1 year and 6 months.
For each cohort, utilization rates will be calculated as the number of diarrhea-related hospitalizations, ER visits, and outpatient visits utilized divided by the cohort's total person-years of observation.
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.
Time Frame: During the study period (from January 2000 up to June 2011), an expected average of 1 year and 6 months.
Costs will be reported on a per-patient per-month (PPPM) basis, using the episode duration in person-months as the weight. For each cohort, an average PPPM cost of first RV episodes will be calculated.
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.
Time Frame: During the study period (from January 2000 up to June 2011), an expected average of 1 year and 6 months.
For each cohort, total RV-related per-patient per-year (PPPY) costs will be calculated as the total cost of RV-related hospitalizations, ER visits, and outpatient visits utilized divided by the cohort's total person-years of observation.
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.
Time Frame: During the study period (from January 2000 up to June 2011), an expected average of 1 year and 6 months.
For each cohort, total diarrhea-related PPPY costs will be calculated as the total cost of diarrhea-related hospitalizations, ER visits, and outpatient visits utilized divided by the cohort's total person-years of observation.
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.
Time Frame: During the study period (from 2000 up to June 2011).
During the study period (from 2000 up to June 2011).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 6, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 10, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 1, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 116829

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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