Condition category
Respiratory
Date applied
15/01/2013
Date assigned
08/02/2013
Last edited
08/02/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English 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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Colin Simpson

ORCID ID

Contact details

University of Edinburgh
Centre for Population Health Sciences
Medical School
Teviot Place
Edinburgh
EH89AG
United Kingdom
+44 (0)131 651 4151
c.simpson@ed.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA: 11/46/23

Study information

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

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

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

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

GP practices

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Pandemic influenza

Intervention

No intervention will be given to patients. Any pandemic influenza vaccine programmes implemented in Scotland will be assessed for effectiveness.

Intervention type

Biological/Vaccine

Phase

Not Applicable

Drug names

Primary outcome measures

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 measures

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.

Overall trial start date

01/01/2013

Overall trial end date

01/01/2050

Reason abandoned

Eligibility

Participant inclusion criteria

All (anonymised) patient data will be collected

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

300000

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/01/2013

Recruitment end date

01/01/2050

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Edinburgh
Edinburgh
EH89AG
United Kingdom

Sponsor information

Organisation

Academic and Clinical Centre Office for Research and Development (ACCORD) (UK)

Sponsor details

c/o Raymond French
The Queen’s Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TJ
United Kingdom
+44 (0)131 242 6226
ray.french@ed.ac.uk

Sponsor type

Research organisation

Website

http://www.ed.ac.uk

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment - HTA (UK) (11/46/23)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes