Condition category
Infections and Infestations
Date applied
19/09/2013
Date assigned
20/01/2014
Last edited
20/01/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The next influenza pandemic will arise suddenly and with little warning. Pandemic influenza can be severe with high death rates or, as was seen in the last pandemic, the strain may be relatively mild with low hospitalisation and death rates. Governments need information on the severity of influenza early in a pandemic to help them decide how much pandemic vaccine and antivirals to order. They need to regularly reassess the situation to decide how best to use these antivirals and vaccines throughout the pandemic. Measuring severity needs large studies to look for evidence of infection in blood samples and to ask people about their illnesses. Research on such a large scale usually takes many months to set up but in a pandemic results are needed much more quickly than this. This research study is designed to overcome this problem by working alongside a very large national survey which already takes place every year -The Health Survey for England. This survey is one of the most important ways we have of monitoring the health of the general public.

Who can participate?
Households across the UK who have a Health Survey of England interview between October 2012 and March 2013 can participate in this study.

What does the study involve?
It involves research nurses visiting households across the country throughout the year to collect detailed health data and to take blood samples (for tests such as cholesterol levels). We will add simple questions (about influenza-like illness and vaccination) and take an additional blood sample (to look for evidence of influenza infection) so that we can quickly measure the severity of a new strain of the influenza virus as soon as it starts to spread. Making this a routine part of a survey that is already running means that the additional cost per participant is minimal and that in a pandemic where time is of the essence, the delays needed to plan the study, get ethical and organisational approvals, and to train staff can be avoided.

What are the possible benefits and risks of participating?
The additional blood sample uses the same needle as the sample that is already being taken and therefore will result in minimal additional discomfort to the participants.

Where is the study run from?
The study is run from households across the UK.

When is study starting and how long is it expected to run for?
The study has two phases, each one lasting a year. Phase one starts in September 2013 and phase 2 (the pandemic phase) would only be initiated in the event of an influenza pandemic.
Who is funding the study?
The National Institute for Health Research (NIHR), UK.

Who is the main contact?
Dr Andrew Hayward
a.hayward@ucl.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Andrew Hayward

ORCID ID

Contact details

UCL Centre for Infectious Disease Epidemiology
Department of Infection and Population Health
Royal Free Campus
Rowland Hill Street
London
NW3 2PF
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NETSCC ID: 11/46/09

Study information

Scientific title

Pandemic Influenza: Population susceptibility, severity and spread: a cross-sectional survey

Acronym

Study hypothesis

The study aims to draw on our experience of large-scale community influenza studies, community surveys, surveillance and serological assays to establish an efficient system allowing real-time assessment of population susceptibility, spread of infection and clinical attack rates.

Objectives:
1. To develop the HSE as a tool for rapid population-based surveys of influenza infection and influenza-like illness rates.
2. To provide monthly measures of numbers of cases infected and weekly updates on numbers of influenza-like illnesses during the first two waves of a pandemic to act as denominators for national estimates of case fatality and hospitalisation rates.
3. To assess spread of the novel influenza strain geographically, by age, and through time.

Ethics approval

Oxford A Research Ethics Committee (REC), 10/H0604/56

Study design

Serial cross-sectional serological prevalence surveys with retrospective ascertainment of vaccination and respiratory illness history in conjunction with the National Health Survey for England (HSE).

Primary study design

Observational

Secondary study design

Cross-section survey

Trial setting

Other

Trial type

Screening

Patient information sheet

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

Condition

Influenza

Intervention

This survey is one of the most important ways we have of monitoring the health of the general public. It involves research nurses visiting households across the country throughout the year to collect detailed health data and to take blood samples (for tests such as cholesterol levels). We will add simple questions (about influenza-like illness and vaccination) and take an additional blood sample (to look for evidence of influenza infection) so that we can rapidly measure the severity of a new strain of influenza as soon as it starts to spread.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Influenza antibody titres - haemagglutination inhibition assay (HIA test)
2. Influenza-like illness - questionnaire

Measured at baseline

Secondary outcome measures

None

Overall trial start date

01/09/2013

Overall trial end date

31/08/2014

Reason abandoned

Eligibility

Participant inclusion criteria

All participants participating in the HSE who have a household interview date between 01/10/2012 and 31/03/2013.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

3216

Participant exclusion criteria

None

Recruitment start date

01/09/2013

Recruitment end date

31/08/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

UCL Centre for Infectious Disease Epidemiology
London
NW3 2PF
United Kingdom

Sponsor information

Organisation

University College London (UCL) (UK)

Sponsor details

Joint Research Office
1st Floor of Maple House
149 Tottenham Court Road
London
W1T 7DN
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK)

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

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