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Early estimation of pandemic influenza Antiviral and Vaccine Effectiveness (EAVE) - use of a unique community and laboratory national linked dataset
ISRCTN ISRCTN55398410
DOI 10.1186/ISRCTN55398410
ClinicalTrials.gov identifier
EudraCT number
Public title Early estimation of pandemic influenza Antiviral and Vaccine Effectiveness (EAVE) - use of a unique community and laboratory national linked dataset
Scientific title Early estimation of pandemic influenza Antiviral and Vaccine Effectiveness (EAVE) - use of a unique community and laboratory national linked dataset: an observational longitudinal cohort study with nested-case control study
Acronym EAVE
Serial number at source HTA: 11/46/23
Study hypothesis Once the study commences, during a twenty-three month preparatory period, we will instigate a data and serology collection linkage system whereby, once a new pandemic occurs, we will be able to undertake a timely analysis of a large national retrospective
observational cohort of patients using a unique community, hospital and laboratory linked dataset.

More details can be found at http://www.hta.ac.uk/2890
Lay summary Background and study aims
In the last century there were three pandemics (global epidemics) of influenza (1918-1919, 1957-58, 1968-1969) producing very large numbers of clinical cases and large numbers of deaths (an estimated 20-40 million, 1 million and 1 million deaths respectively) as the population had little immunity to the novel influenza viruses involved (H1N1, H2N2, H3N2 respectively). Immunisation programmes delivered in primary healthcare settings have been shown to be acceptable (as evidenced by previous high uptake rates) and effective, and this will therefore be the mainstay of disease prevention in any new influenza pandemic.
Any new influenza vaccination will likely be targeted at those who are at increased risk of serious illness or death from influenza like illness. Observational studies can be used to estimate the effectiveness of healthcare interventions in situations where it is
unethical and/or not feasible to mount more rigorous experimental studies; such is the case with the introduction of a new pandemic influenza vaccine. Observational studies can also assess the effects of healthcare interventions without influencing the care that is provided or the patients who receive it. Results from these studies are generalisable in that they can be used by other countries or regions to help guide public health policy. The potential novelty of a new pandemic virus requires that a high degree of vigilance at both the epidemiological and microbiological levels accompanies the implementation of a vaccine programme for the whole population. Policymakers will be reassured if:
1) Early evidence can be gathered that the new pandemic vaccine is widely acceptable as evidenced by high uptake rates and is being distributed by primary care as a priority to those at most risk of adverse effects of the virus especially if some groups are more susceptible than others e.g. children, the elderly, the most socioeconomically deprived or pregnant women and those deemed to be at-risk on the basis of existing illnesses and
2) if the vaccine is known, at an early stage, to be effective in preventing influenza like illness and death.
By extracting the relevant de- identified electronic patient information from general practice, which includes age, sex, illness data, vaccination and prescribing information and linking this with laboratory data of patients with suspected new pandemic influenza and information on previous exposures to past pandemic A/H1N1 influenza and/or seasonal influenza and also information on death from the General Register for Scotland dataset; from this compiled dataset, we will be able to determine the:
1) Uptake of the new pandemic vaccine by the relevant at risk populations
2) The identification of susceptible groups in the population to help target the vaccination
3) Reduction in the expected incidence of influenza related serious morbidity and mortality in the most susceptible risk groups, since this is the major rationale behind the immunisation policy; and
4) Effectiveness of the pandemic vaccine/antivirals in the whole population.

Who can participate?
The setting for this project will be general practices based throughout Scotland. These practices have about 300,000 people registered with them and will be included in the project.

What does the study involve?
In the event of an influenza pandemic, the general practices enrolled will provide sufficient data to allow linkage to serology, virology and clinical outcome data to establish an anonymised dataset which can allow estimates of attack rate and vaccine/ antiviral effectiveness.

What are the possible benefits and risks of participating?
The will be no risks and no direct benefit to patients, rather this project will help inform policy makers and any vaccination or antiviral programme in the event of a new pandemic.

Where is the study run from?
The project is being jointly led by Health Protection Scotland and the Universities of Aberdeen, Edinburgh and Strathclyde.

When is the study starting and how long is it expected to run for?
The project will start in 2013. If there is no pandemic the project will be placed into hibernation from 2014.

Who is funding the study?
The project is being funded by the NIHR Health Technology Assessment programme.

Who is the main contact?
Dr Colin Simpson
c.simpson@ed.ac.uk
Ethics approval South East Scotland Research Ethics Committee 02, 15 November 2012, ref: 12\ss\0201
Study design Observational longitudinal cohort study with nested-case control study
Countries of recruitment United Kingdom
Disease/condition/study domain Pandemic influenza
Participants - inclusion criteria All (anonymised) patient data will be collected
Participants - exclusion criteria Does not meet inclusion criteria
Anticipated start date 01/01/2013
Anticipated end date 01/01/2050
Status of trial Ongoing
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 300000
Interventions No intervention will be given to patients. Any pandemic influenza vaccine programmes implemented in Scotland will be assessed for effectiveness.
Primary outcome measure(s) The vaccination uptake in the relevant ‘at risk’ populations (patients <65 with ‘at-risk’ co-morbidities and those >65 years) and the general population recorded by general practices
Secondary outcome measure(s) 1. Influenza positivity from virological swab data in vaccinated and unvaccinated patients stratified by ‘at-risk’ populations, age, sex and socioeconomic status.
2. Influenza positivity from serology data in vaccinated and unvaccinated patients stratified by ‘at-risk’ populations, age, sex and socioeconomic status, which will permit the estimation of incidence of influenza.
3. Consultation for influenza-related morbidity (e.g. influenza, pneumonia, chronic obstructive pulmonary disease [COPD] and cardiac related consultations) and issue of antiviral therapy from general practice data in vaccinated and unvaccinated patients stratified by ‘at-risk’ populations, age, sex and socio-economic status
4. Mortality and influenza-related serious morbidity (e.g. influenza, pneumonia, COPD and cardiac related death and hospitalisation from SMR01 records) in vaccinated and unvaccinated patients stratified by ‘at-risk’ populations, age, sex and socioeconomic status
5. For patients with stored serology (and prior to the introduction of any vaccination) whether cross-reactivity occurs due to previous exposure to A/H1N1 or A/H1N1 vaccination, other pandemic influenza or other seasonal influenza vaccination or exposure.
Sources of funding NIHR Health Technology Assessment - HTA (UK) (11/46/23)
Trial website
Publications
Contact name Dr  Colin  Simpson
  Address University of Edinburgh
Centre for Population Health Sciences
Medical School
Teviot Place
  City/town Edinburgh
  Zip/Postcode EH89AG
  Country United Kingdom
  Tel +44 (0)131 651 4151
  Fax +44 (0)131 650 9119
  Email c.simpson@ed.ac.uk
Sponsor Academic and Clinical Centre Office for Research and Development (ACCORD) (UK)
  Address c/o Raymond French
The Queen’s Medical Research Institute
47 Little France Crescent
  City/town Edinburgh
  Zip/Postcode EH16 4TJ
  Country United Kingdom
  Tel +44 (0)131 242 6226
  Fax +44 (0)131 242 9447
  Email ray.french@ed.ac.uk
  Sponsor website: http://www.ed.ac.uk
Date applied 15/01/2013
Last edited 08/02/2013
Date ISRCTN assigned 08/02/2013
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