Influenza Burden Assessment in the United States, July1997 - up to April 2009

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01599390
Recruitment Status : Completed
First Posted : May 16, 2012
Last Update Posted : February 25, 2013
Sage Analytica
Information provided by (Responsible Party):

Brief Summary:
The study will assess the burden of severe influenza outcomes by age, risk status, and influenza subtype, in order to create a profile of the burden of influenza-related morbidity and mortality in United States from July 1997 to April 2009.

Condition or disease Intervention/treatment
Influenza Other: Data collection

Detailed Description:
This epidemiological study is a modelling of time series retrospectively extracted from multiple databases. Data will be extracted from existing electronic healthcare databases.

Study Type : Observational
Actual Enrollment : 1 participants
Time Perspective: Retrospective
Official Title: Burden of Influenza in the United States, July 1997 up to April 2009
Study Start Date : July 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Group/Cohort Intervention/treatment
Influenza Group Other: Data collection

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.

Primary Outcome Measures :
  1. 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) ]
  2. 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) ]

Secondary Outcome Measures :
  1. Influenza vaccine content and effectiveness by season. [ Time Frame: From July 1997 to April 2009 (i.e., up to almost 12 years) ]
  2. Influenza vaccine coverage by season. [ Time Frame: From July 1997 to April 2009 (i.e., up to almost 12 years) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All records of people in the US in the Nationwide Inpatient Sample (NIS) hospitalization data or in the US mortality data will be included in this study.

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01599390

Sponsors and Collaborators
Sage Analytica
Study Director: GSK Clinical Trials GlaxoSmithKline

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: GlaxoSmithKline Identifier: NCT01599390     History of Changes
Other Study ID Numbers: 116730
First Posted: May 16, 2012    Key Record Dates
Last Update Posted: February 25, 2013
Last Verified: February 2013

Keywords provided by GlaxoSmithKline:
United States
Burden of Disease

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases