Pandemic Influenza: Population susceptibility, severity and spread: Rapid Research using the Health Survey for England (HSE)

ISRCTN	ISRCTN80214280
DOI	https://doi.org/10.1186/ISRCTN80214280
Secondary identifying numbers	NETSCC ID: 11/46/09

Submission date: 19/09/2013
Registration date: 20/01/2014
Last edited: 02/02/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Dr Andrew Hayward
Scientific

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

Study information

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
Study setting(s)	Other
Study type	Screening
Participant information sheet	Not available in web format, please use the contact details below to request a participant information sheet
Scientific title	Pandemic Influenza: Population susceptibility, severity and spread: a cross-sectional survey
Study objectives	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(s)	Oxford A Research Ethics Committee (REC), 10/H0604/56
Health condition(s) or problem(s) studied	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
Primary outcome measure	1. Influenza antibody titres - haemagglutination inhibition assay (HIA test) 2. Influenza-like illness - questionnaire Measured at baseline
Secondary outcome measures	None
Overall study start date	01/09/2013
Completion date	31/08/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	3216
Key inclusion criteria	All participants participating in the HSE who have a household interview date between 01/10/2012 and 31/03/2013.
Key exclusion criteria	None
Date of first enrolment	01/09/2013
Date of final enrolment	31/08/2014

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

UCL Centre for Infectious Disease Epidemiology

London
NW3 2PF
United Kingdom

Sponsor information

University College London (UCL) (UK)
University/education

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

"ROR"	https://ror.org/02jx3x895

Funders

Funder type

Government

National Institute for Health Research (NIHR) (UK)
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2015		Yes	No
HRA research summary			28/06/2023	No	No

Editorial Notes

02/02/2017: Publication reference added.