Impact of Complete and Incomplete Rotavirus Vaccination on Health Outcomes and Costs
This observational study aims to evaluate the clinical and cost impacts of complete and incomplete rotavirus (RV) vaccination in children under 5 years old, by assessing the incidence of first RV episodes, related resource utilization, and healthcare costs.
Data Collection
+ other Data
+ other Data
Collected from past medical records and data - RetrospectiveInfections+2
+ Reoviridae Infections
+ RNA Virus Infections
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: August 1, 2012
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.1 patient to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Until 5 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.7 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Study Objectives
Primary Objectives