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OpenTrials
Completed

NCT Number: NCT01599390

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

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.

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Collaborators

  • Sage Analytica

Registry information

Official study title

Burden of Influenza in the United States, July 1997 up to April 2009

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 16, 2012
Registry last updated
Feb 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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