Contact information
Type
Scientific
Primary contact
Dr Margot Gosney
ORCID ID
Contact details
Institute of Health Sciences
University of Reading
Building 22
1st Floor
London Road
Reading
RG1 5AQ
United Kingdom
+44 (0)118 378 6850
m.a.gosney@reading.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 97/20/06
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measure
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.
Secondary outcome measures
Not provided at time of registration.
Overall trial start date
01/09/1999
Overall trial end date
31/08/2002
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
65-74 year olds
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
Not provided at time of registration.
Participant exclusion criteria
Aged over 75 years
Recruitment start date
01/09/1999
Recruitment end date
31/08/2002
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Institute of Health Sciences
Reading
RG1 5AQ
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NIHR Health Technology Assessment Programme - HTA (UK)
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
Basic results (scientific)
Publication list
Publication citations
-
Allsup S, Gosney M, Haycox A, Regan M, Cost-benefit evaluation of routine influenza immunisation in people 65-74 years of age., Health Technol Assess, 2003, 7, 24, iii-x, 1-65.