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

NCT01599390 | Completed

• 1 other identifier: 116730
• Study Type: observational
• Target: 1
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Influenza

Keywords

United States; Burden of Disease; Influenza

Outcome Measures

Primary Outcomes (2)

• Occurrences of potentially influenza-attributable hospitalization or death by age, risk status, region and season.

  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.

  From July 1997 to April 2009 (i.e., up to almost 12 years)

Secondary Outcomes (2)

• Influenza vaccine content and effectiveness by season.

  From July 1997 to April 2009 (i.e., up to almost 12 years)

• Influenza vaccine coverage by season.

  From July 1997 to April 2009 (i.e., up to almost 12 years)

Study Arms (1)

Influenza Group

Other: Data collection

Interventions

Data collection OTHER

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.

Influenza Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Recorded in the US NIS hospitalization data or the US National Vital Statistics System (NVSS) mortality data with a pre-specified diagnostic code.

You may not qualify if:

• Missing data in the following fields: age, primary discharge diagnosis, admission month (NIS) /month of death (NVSS), and status at discharge (alive / dead).

Sponsors & Collaborators

• GlaxoSmithKline: lead
• Sage Analytica: collaborator

Related Publications (1)

• Matias G, Taylor R, Haguinet F, Schuck-Paim C, Lustig R, Shinde V. Estimates of hospitalization attributable to influenza and RSV in the US during 1997-2009, by age and risk status. BMC Public Health. 2017 Mar 21;17(1):271. doi: 10.1186/s12889-017-4177-z.

  PMID: 28320361 DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; 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
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2012
• First Posted: May 16, 2012
• Study Start: July 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: February 25, 2013

Record last verified: 2013-02