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

NCT01682005 | Completed

• 1 other identifier: 116829
• Study Type: observational
• Target: 1
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Infections, Rotavirus

Keywords

Cost; Children; Rotavirus; Rotavirus vaccination; Clinical

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

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

Study Arms (7)

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

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

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

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

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

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

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

Interventions

Data interpretation 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; Complete RV vaccination; Contemporary unvaccinated after 8 months old; Contemporary unvaccinated on/before 8 months old; Historical unvaccinated after 8 months old; Historical unvaccinated on/before 8 months old; Incomplete RV vaccination

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• Received both medical and pharmacy benefits.

You may not qualify if:

• Enrolled in capitation-based health plans.
• Lost to follow-up or had RV prior to 6 weeks of age.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Related Publications (1)

• 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.

  PMID: 26751375 DERIVED

MeSH Terms

Conditions

Rotavirus Infections

Interventions

Data Interpretation, Statistical

Condition Hierarchy (Ancestors)

Reoviridae Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Decision Support Techniques; Investigative Techniques; Statistics as Topic; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment 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: September 6, 2012
• First Posted: September 10, 2012
• Study Start: August 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: September 1, 2014

Record last verified: 2014-08