Trial record 2 of 290 for:    april

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

This study has been completed.
Sponsor:
Collaborator:
Sage Analytica
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01599390
First received: May 14, 2012
Last updated: February 21, 2013
Last verified: February 2013
  Purpose

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 Intervention
Influenza
Other: Data collection

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Burden of Influenza in the United States, July 1997 up to April 2009

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Influenza vaccine content and effectiveness by season. [ Time Frame: From July 1997 to April 2009 (i.e., up to almost 12 years) ] [ Designated as safety issue: No ]
  • Influenza vaccine coverage by season. [ Time Frame: From July 1997 to April 2009 (i.e., up to almost 12 years) ] [ Designated as safety issue: No ]

Enrollment: 1
Study Start Date: July 2012
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Influenza Group
NA
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.


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.

  Eligibility

Genders Eligible for Study:   Both
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.

Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01599390

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

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01599390     History of Changes
Other Study ID Numbers: 116730
Study First Received: May 14, 2012
Last Updated: February 21, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
United States
Burden of Disease
Influenza

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

ClinicalTrials.gov processed this record on October 20, 2014