Infections, RotavirusNCT01915888
Study to Analyze the Clinical and Cost Impact of Complete and Incomplete Rotarix Vaccination
An observational study of Infections, Rotavirus, run by GlaxoSmithKline.
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. Read more about this study
- Who is it for?
- Ages Up to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Infections, Rotavirus
- What is being tested?
- Data interpretation
- Type of treatment
- Vaccines
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Aug 2013to Feb 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children less than 5 years old continuously enrolled in commercial insurance or Medicaid from birth, and received both medical and pharmacy benefits.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Clinical and Cost Impact of Complete and Incomplete Rotarix Vaccination
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).
Read the detailed 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:
- Rotarix vaccination according to compliance with the Advisory Committee on Immunization Practices (ACIP)-specified vaccination window of 6 weeks to 8 months old.
- 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.
- Conditions
- Infections, Rotavirus
- Being tested
- Data interpretation
- Keywords
- Clinical, Children, Rotavirus, Cost, Rotarix vaccination
- Medical subject headings
- Rotavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data interpretationOther
The data collected for each group will be fully de-identified, interpreted and analysed separately for the 2 databases (MarketScan Commercial and MarketScan Medicaid).
| Study group | Role | What they receive |
|---|---|---|
| Complete Rotarix vaccination cohort | Subjects had received 2 doses of Rotarix within the vaccination window and the observation time is from the end of the vaccination window (8 months old for ACIP scenario, or 6 months old for PI scenario) to end of observation. Receives: Other: Data interpretation | |
| Incomplete Rotarix vaccination cohort | Subjects had received one vaccination of Rotarix within the vaccination window and the observation time is from end of vaccination window (8 months old for ACIP scenario, or 6 months old for PI scenario)(if still observed) to end of observation. Receives: Other: Data interpretation | |
| Historical unvaccinated cohort | Subjects did not receive any Rotarix vaccine dose within the vaccination window and the observation time is from end of the vaccination window (8 months old for ACIP scenario, or 6 months old for PI scenario, if vaccination window ends on/before 12/31/2006) to end of observation. Receives: Other: Data interpretation | |
| Contemporary unvaccinated cohort | Subjects did not receive any Rotarix vaccine dose within the vaccination window and the observation time is from end of the vaccination window (8 months old for ACIP scenario, or 6 months old for PI scenario, if vaccination window ends after 1/1/2007) to end of observation. Receives: Other: Data interpretation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During the study period (from 2000 up to 2010)
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
Measured: During the study period (from 2000 up to 2010)
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
Measured: During the study period (from 2000 up to 2010)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infections, RotavirusStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Analysis Group, Inc.
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01915888
- Sponsor's protocol ID
- 116830
- Status last verified
- Nov 2014
- First submitted
- 25 Jul 2013
- Last updated
- 17 Nov 2014
- Results posted
- No
Publications
Krishnarajah G, Kageleiry A, Korves C, Lefebvre P, Duh MS. Public health impact of Rotarix vaccination among commercially insured children in the United States. Vaccine. 2017 Sep 5;35(37):5065-5072. doi: 10.1016/j.vaccine.2017.06.034. Epub 2017 Aug 1.
PubMed 28778611
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Cost Impact of Complete and Incomplete Rotarix Vaccination
- ClinicalTrials.gov ID
- NCT01915888
- Acronym / sponsor ID
- 116830
- Conditions
- Infections, Rotavirus
- Keywords
- Clinical, Children, Rotavirus, Cost, Rotarix vaccination
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Collaborators
- Analysis Group, Inc.
- Study start
- Aug 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 5 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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:
- Rotarix vaccination according to compliance with the Advisory Committee on Immunization Practices (ACIP)-specified vaccination window of 6 weeks to 8 months old.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Complete Rotarix vaccination cohort | – | Other: Data interpretationSubjects had received 2 doses of Rotarix within the vaccination window and the observation time is from the end of the vaccination window (8 months old for ACIP scenario, or 6 months old for PI scenario) to end of observation. |
| Incomplete Rotarix vaccination cohort | – | Other: Data interpretationSubjects had received one vaccination of Rotarix within the vaccination window and the observation time is from end of vaccination window (8 months old for ACIP scenario, or 6 months old for PI scenario)(if still observed) to end of observation. |
| Historical unvaccinated cohort | – | Other: Data interpretationSubjects did not receive any Rotarix vaccine dose within the vaccination window and the observation time is from end of the vaccination window (8 months old for ACIP scenario, or 6 months old for PI scenario, if vaccination window ends on/before 12/31/2006) to end of observation. |
| Contemporary unvaccinated cohort | – | Other: Data interpretationSubjects did not receive any Rotarix vaccine dose within the vaccination window and the observation time is from end of the vaccination window (8 months old for ACIP scenario, or 6 months old for PI scenario, if vaccination window ends after 1/1/2007) to end of observation. |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children less than 5 years old continuously enrolled in commercial insurance or Medicaid from birth, and received both medical and pharmacy benefits.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data interpretationThe data collected for each group will be fully de-identified, interpreted and analysed separately for the 2 databases (MarketScan Commercial and MarketScan Medicaid). | Other | Complete Rotarix vaccination cohort, Contemporary unvaccinated cohort, Historical unvaccinated cohort, Incomplete Rotarix vaccination cohort |
Primary outcome
Incidence of first RV episode
Time frame: During the study period (from 2000 up to 2010)
Estimation and comparison of the clinical impact of complete and incomplete Rotarix vaccination among children less than 5 years of age
Incidence of RV-related utilization
Time frame: During the study period (from 2000 up to 2010)
Estimation and comparison of the clinical impact of complete and incomplete Rotarix vaccination among children less than 5 years of age
Incidence of diarrhea-related utilization
Time frame: During the study period (from 2000 up to 2010)
Estimation and comparison of the clinical impact of complete and incomplete Rotarix vaccination among children less than 5 years of age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2014.
- Derived from this study: PubMed 28778611Krishnarajah G, Kageleiry A, Korves C, Lefebvre P, Duh MS. Public health impact of Rotarix vaccination among commercially insured children in the United States. Vaccine. 2017 Sep 5;35(37):5065-5072. doi: 10.1016/j.vaccine.2017.06.034. Epub 2017 Aug 1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
An observational study of Infections, Rotavirus, run by GlaxoSmithKline.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of first RV episode (time frame: During the study period (from 2000 up to 2010)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01915888, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2014.