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ISRCTN
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ISRCTN27879030
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ClinicalTrials.gov identifier
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Public title
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Cost benefit evaluation of routine influenza immunisation in subjects 65-74 years of age
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Scientific title
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Acronym
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N/A
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Serial number at source
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HTA 97/20/06
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Study hypothesis
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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.
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Ethics approval
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Not provided at time of registration.
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Infection and infestations: Influenza
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Participants - inclusion criteria
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65-74 year olds
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Participants - exclusion criteria
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Aged over 75 years
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Anticipated start date
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01/09/1999
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Anticipated end date
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31/08/2001
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Status of trial
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Completed
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Patient information material
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Target number of participants
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Not provided at time of registration.
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Interventions
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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.
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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Not provided at time of registration.
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Sources of funding
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NIHR Health Technology Assessment Programme - HTA (UK)
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Trial website
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Publications
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http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=14499051
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Contact name
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Dr
Margot
Gosney
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Address
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Institute of Health Sciences
University of Reading
Building 22
1st Floor
London Road
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City/town
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Reading
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Zip/Postcode
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RG1 5AQ
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Country
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United Kingdom
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Tel
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+44 (0)118 378 6850
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Fax
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+44 (0)118 931 0080
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Email
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m.a.gosney@reading.ac.uk
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Sponsor
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Department of Health (UK)
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Address
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Quarry House
Quarry Hill
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City/town
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Leeds
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Zip/Postcode
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LS2 7UE
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Country
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United Kingdom
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Email
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Sheila.Greener@doh.gsi.gov.uk
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Sponsor website:
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http://www.dh.gov.uk/en/index.htm
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Date applied
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25/04/2003
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Last edited
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24/01/2008
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Date ISRCTN assigned
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25/04/2003
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