InfluenzaNCT01520935
Influenza Burden Assessment in the United Kingdom, 1996-2008
An observational study of Influenza, run by GlaxoSmithKline.
Trial summary
The study will assess the burden of influenza by age, risk status, vaccination status and influenza subtype, in order to create a complete profile of the burden of influenza-related morbidity and mortality in United Kingdom from 1996 to 2008. 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: People of any age in the United Kingdom who were registered with an acceptable flag in the GPRD, or with a potentially influenza-related event in the HES database or the ONS mortality data.
Who may be able to join
- Registration with an acceptable flag in the GPRD, or registration with a potentially influenza-related event in the HES database or the ONS mortality data.
Who cannot join
- -
About this study
Official title: Burden of Influenza in the United Kingdom, 1996-2008
The study will assess the burden of influenza by age, risk status, vaccination status and influenza subtype, in order to create a complete profile of the burden of influenza-related morbidity and mortality in United Kingdom from 1996 to 2008.
Read the detailed description
This epidemiological study is a modelling of time series retrospectively extracted from multiple databases. The data collection will be a query of existing electronic healthcare databases.
- Conditions
- Influenza
- Being tested
- Data collection
- Keywords
- Office of National Statistics, Burden of Disease, Influenza, Hospital Episode Statistics, General Practitioners Research Database
- 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 four primary data sources: the General Practice Research Database (GPRD, for mild outcomes), the Hospital Episode Statistics database (HES, for hospitalizations), the Office of National Statistics mortality database (ONS, for mortality), and weekly virology data from the Health Protection Agency (HPA).
Weekly time series of the rates of various influenza-related health outcomes in the various databases, such as office visits for acute otitis media and hospitalizations for pneumonia will be constructed. Statistical models, guided by weekly numbers of cases of laboratory-confirmed influenza and respiratory syncytial virus (RSV) contained in the HPA virology data, to estimate the portions of the various outcomes that can be attributed to influenza will be constructed. Finally, the seasonal impact of influenza by risk status, vaccination status, and seasons in which a well-matched versus mismatched influenza vaccine was used, will be assessed.
| Study group | Role | What they receive |
|---|---|---|
| Cohort Group | Not described Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of medically attended health outcomes (~20 relevant mild and severe) related to influenza
Measured: From 1996 to 2008 (up to 13 years)
Relative impact of influenza on high versus low risk populations
Measured: From 1996 to 2008 (up yo 13 years)
Relative impact of influenza during match versus mismatched seasons
Measured: From 1996 to 2008 (up to 13 years)
Relative impact of influenza on vaccinated versus unvaccinated populations
Measured: From 1996 to 2008 (up to 13 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2012 (estimated)
- Study startSep 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- NCT01520935
- Sponsor's protocol ID
- 116273
- Status last verified
- Sep 2012
- First submitted
- 23 Jan 2012
- Last updated
- 10 Sep 2012
- Results posted
- No
Publications
Matias G, Taylor RJ, Haguinet F, Schuck-Paim C, Lustig RL, Fleming DM. Modelling estimates of age-specific influenza-related hospitalisation and mortality in the United Kingdom. BMC Public Health. 2016 Jun 8;16:481. doi: 10.1186/s12889-016-3128-4.
PubMed 27278794Fleming DM, Taylor RJ, Haguinet F, Schuck-Paim C, Logie J, Webb DJ, Lustig RL, Matias G. Influenza-attributable burden in United Kingdom primary care. Epidemiol Infect. 2016 Feb;144(3):537-47. doi: 10.1017/S0950268815001119. Epub 2015 Jul 13.
PubMed 26168005
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Burden of Influenza in the United Kingdom, 1996-2008
- ClinicalTrials.gov ID
- NCT01520935
- Acronym / sponsor ID
- 116273
- Conditions
- Influenza
- Keywords
- Office of National Statistics, Burden of Disease, Influenza, Hospital Episode Statistics, General Practitioners Research Database
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Collaborators
- Sage Analytica
- Study start
- Sep 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 30 Jan 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 influenza by age, risk status, vaccination status and influenza subtype, in order to create a complete profile of the burden of influenza-related morbidity and mortality in United Kingdom from 1996 to 2008.
Detailed description
This epidemiological study is a modelling of time series retrospectively extracted from multiple databases. The data collection will be a query of existing electronic healthcare databases.
Study design
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort Group | – | Other: Data collection |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- People of any age in the United Kingdom who were registered with an acceptable flag in the GPRD, or with a potentially influenza-related event in the HES database or the ONS mortality data.
Key inclusion criteria (1 listed)
- Registration with an acceptable flag in the GPRD, or registration with a potentially influenza-related event in the HES database or the ONS mortality data.
Key exclusion criteria (1 listed)
- -
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 four primary data sources: the General Practice Research Database (GPRD, for mild outcomes), the Hospital Episode Statistics database (HES, for hospitalizations), the Office of National Statistics mortality database (ONS, for mortality), and weekly virology data from the Health Protection Agency (HPA). Weekly time series of the rates of various influenza-related health outcomes in the various databases, such as office visits for acute otitis media and hospitalizations for pneumonia will be constructed. Statistical models, guided by weekly numbers of cases of laboratory-confirmed influenza and respiratory syncytial virus (RSV) contained in the HPA virology data, to estimate the portions of the various outcomes that can be attributed to influenza will be constructed. Finally, the seasonal impact of influenza by risk status, vaccination status, and seasons in which a well-matched versus mismatched influenza vaccine was used, will be assessed. | Other | Cohort Group |
Primary outcome
Incidence of medically attended health outcomes (~20 relevant mild and severe) related to influenza
Time frame: From 1996 to 2008 (up to 13 years)
Relative impact of influenza on high versus low risk populations
Time frame: From 1996 to 2008 (up yo 13 years)
Relative impact of influenza during match versus mismatched seasons
Time frame: From 1996 to 2008 (up to 13 years)
Relative impact of influenza on vaccinated versus unvaccinated populations
Time frame: From 1996 to 2008 (up to 13 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 10 Sep 2012.
- Derived from this study: PubMed 27278794Matias G, Taylor RJ, Haguinet F, Schuck-Paim C, Lustig RL, Fleming DM. Modelling estimates of age-specific influenza-related hospitalisation and mortality in the United Kingdom. BMC Public Health. 2016 Jun 8;16:481. doi: 10.1186/s12889-016-3128-4.
- Derived from this study: PubMed 26168005Fleming DM, Taylor RJ, Haguinet F, Schuck-Paim C, Logie J, Webb DJ, Lustig RL, Matias G. Influenza-attributable burden in United Kingdom primary care. Epidemiol Infect. 2016 Feb;144(3):537-47. doi: 10.1017/S0950268815001119. Epub 2015 Jul 13.
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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 10 Sep 2012. 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?
Incidence of medically attended health outcomes (~20 relevant mild and severe) related to influenza (time frame: From 1996 to 2008 (up to 13 years)). The study lists 4 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 NCT01520935, which also lists 2 linked publications.
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 10 Sep 2012; AzTrials last refreshed its copy on 7 Nov 2026.