InfluenzaNCT01599390
Influenza Burden Assessment in the United States, July1997 - up to April 2009
An observational study of Influenza, run by GlaxoSmithKline.
Trial 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. Read more about this study
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Recorded in the US NIS hospitalization data or the US National Vital Statistics System (NVSS) mortality data with a pre-specified diagnostic code.
Who cannot join
- Missing data in the following fields: age, primary discharge diagnosis, admission month (NIS) /month of death (NVSS), and status at discharge (alive / dead).
About this study
Official title: Burden of Influenza in the United States, July 1997 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.
Read the 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.
- Conditions
- Influenza
- Being tested
- Data collection
- Keywords
- United States, Burden of Disease, Influenza
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Influenza Group | Not described Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrences of potentially influenza-attributable hospitalization or death by age, risk status, region and season.
Measured: 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.
Measured: From July 1997 to April 2009 (i.e., up to almost 12 years)
Secondary outcomes (2)
Influenza vaccine content and effectiveness by season.
Measured: From July 1997 to April 2009 (i.e., up to almost 12 years)
Influenza vaccine coverage by season.
Measured: From July 1997 to April 2009 (i.e., up to almost 12 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2012 (estimated)
- Study startJul 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sage Analytica
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01599390
- Sponsor's protocol ID
- 116730
- Status last verified
- Feb 2013
- First submitted
- 14 May 2012
- Last updated
- 25 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28320361
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Burden of Influenza in the United States, July 1997 up to April 2009
- ClinicalTrials.gov ID
- NCT01599390
- Acronym / sponsor ID
- 116730
- Conditions
- Influenza
- Keywords
- United States, Burden of Disease, Influenza
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Collaborators
- Sage Analytica
- Study start
- Jul 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 16 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Influenza Group | – | Other: Data collection |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Recorded in the US NIS hospitalization data or the US National Vital Statistics System (NVSS) mortality data with a pre-specified diagnostic code.
Key exclusion criteria (1 listed)
- Missing data in the following fields: age, primary discharge diagnosis, admission month (NIS) /month of death (NVSS), and status at discharge (alive / dead).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collectionThe 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. | Other | Influenza Group |
Primary outcome
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)
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)
2 secondary outcomes
Influenza vaccine content and effectiveness by season.
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2013.
- Derived from this study: PubMed 28320361Matias 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza, run by GlaxoSmithKline.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01599390, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2013; AzTrials last refreshed its copy on 8 Nov 2026.