Cost benefit evaluation of routine influenza immunisation in subjects 65-74 years of age

ISRCTN	ISRCTN27879030
DOI	https://doi.org/10.1186/ISRCTN27879030
Protocol serial number	HTA 97/20/06
Sponsor	Department of Health (UK)
Funder	NIHR Health Technology Assessment Programme - HTA (UK)

Submission date: 25/04/2003
Registration date: 25/04/2003
Last edited: 10/07/2019

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

Not provided at time of registration

Contact information

Dr Margot Gosney
Scientific

Institute of Health Sciences
University of Reading
Building 22
1st Floor
London Road
Reading
RG1 5AQ
United Kingdom

Phone	+44 (0)118 378 6850
Email	m.a.gosney@reading.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Cost benefit evaluation of routine influenza immunisation in subjects 65-74 years of age
Study objectives	We have already shown in Merseyside that <50% of high risk elderly patients admitted to hospital with acute medical illnesses have received influenza vaccination. As a result of this study 8 Practices have been recruited as a PCII. In each of these Practices a Data Manager funded by the Health Authority is already accruing data on influenza-type illnesses as well as epidemiological data. These Practices are the obvious sites for this study representing a typical elderly population seen in inner cities. North Mersey Community Trust are already training Nurse Immunisers and we are confident with this manpower we could vaccinate the anticipated numbers required during a 4-6 week period. We believe that the applying group have the necessary experience and expertise to identify suitable subjects in the Practices, manage a complex immunisation programme, coordinate the necessary end point measures and analyse the resultant data. We have the necessary links with the Pharmacy Department of a teaching hospital familiar with randomisation and drug distribution for various clinical trials. We have the support of the 8 Practices involved in PCII and that of the Director of Public Health for Liverpool. We have access to University computing and library facilities necessary for the data handling and systematic review respectively. Please note that, as of 11/05/2009, the anticipated end date has been updated from 31/08/2001 to 31/08/2002.
Ethics approval(s)	Not provided at time of registration.
Health condition(s) or problem(s) studied	Infection and infestations: Influenza
Intervention	Please note that, as of 14 January 2008, the anticipated end date of this trail has been updated from 31 August 2001 to 31 August 2002. Interventions: 1. Pneumococcal and influenza 2. Pneumococcal and placebo.
Intervention type	Other
Primary outcome measure(s)	1.1 Hospital admission with or without respiratory illness 1.2 GP consultation for respiratory and non-respiratory disease 1.3 Self- reported patient illness and over the counter medication 1.4 Quality of Life measures at 3, 6, 9 and 12 months post vaccination. 2. To determine the cost effectiveness of the vaccination. 3. To determine whether factors such as age, sex, co-morbidity and social class affects, 3.1 entry into the trial, 3.2 the receipt or otherwise of the influenza vaccination outside the clinical trial, 3.3 cost effectiveness.
Key secondary outcome measure(s)	Not provided at time of registration.
Completion date	31/08/2002

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Total final enrolment	729
Key inclusion criteria	65-74 year olds
Key exclusion criteria	Aged over 75 years
Date of first enrolment	01/09/1999
Date of final enrolment	31/08/2002

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Institute of Health Sciences

Reading
RG1 5AQ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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	01/02/2003		Yes	No

Editorial Notes

10/07/2019: Total final enrolment added.