- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01599390
Influenza Burden Assessment in the United States, July1997 - up to April 2009
Burden of Influenza in the United States, July 1997 up to April 2009
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Recorded in the US NIS hospitalization data or the US National Vital Statistics System (NVSS) mortality data with a pre-specified diagnostic code.
Exclusion Criteria:
- Missing data in the following fields: age, primary discharge diagnosis, admission month (NIS) /month of death (NVSS), and status at discharge (alive / dead).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Influenza Group
|
The study will use multiple primary data sources: the Nationwide Inpatient Sample (for hospitalisations) and the US National Vital Statistics System (for mortality), and weekly virology data from the Centers for Disease Control and Prevention (CDC) influenza surveillance program supplemented with literature data. Weekly time series of the rates of various severe influenza-related health outcomes will be constructed. Statistical models, guided by weekly numbers of cases of laboratory-confirmed influenza and respiratory syncytial virus (RSV) contained in the CDC virology data, will be constructed to estimate the portions of the various outcomes that can be attributed to influenza. Next, the seasonal impact of influenza by age, risk status, and influenza subtype will be assessed. Finally, the potential burden that a quadrivalent vaccine could have prevented over the 12 year study period will be predicted. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Occurrences of potentially influenza-attributable hospitalization or death by age, risk status, region and season.
Time Frame: From July 1997 to April 2009 (i.e., up to almost 12 years)
|
From July 1997 to April 2009 (i.e., up to almost 12 years)
|
Amount of circulating influenza A and B, and RSV strains determined for each season.
Time Frame: From July 1997 to April 2009 (i.e., up to almost 12 years)
|
From July 1997 to April 2009 (i.e., up to almost 12 years)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Influenza vaccine content and effectiveness by season.
Time Frame: From July 1997 to April 2009 (i.e., up to almost 12 years)
|
From July 1997 to April 2009 (i.e., up to almost 12 years)
|
Influenza vaccine coverage by season.
Time Frame: From July 1997 to April 2009 (i.e., up to almost 12 years)
|
From July 1997 to April 2009 (i.e., up to almost 12 years)
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 116730 (Western University's Research Ethics Board)
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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