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ISRCTN
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ISRCTN28553709
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ClinicalTrials.gov identifier
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Public title
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Influenza vaccine in nursing homes - why doesn't it work?
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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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SL&M Research Ethics Committee 04/045
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Study hypothesis
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Primary Objectives: To determine whether assessing antibody response to the influenza vaccine, and administering a booster vaccination if the antibody response is inadequate, is more effective in reducing hospitalisation and death rates than current standard practice.
Secondary Objectives: To estimate the overall antibody response rate to the influenza vaccine in the trial population; To investigate whether non-response to the influenza vaccine is associated with HLA type, psychiatric diagnosis, Cornell score or MMSE score; To investigate whether assessing antibody response to the influenza vaccine, and administering a booster vaccination if the antibody response is inadequate, increases antibody response rates relative to current standard practice; To investigate what baseline factors predict clinical response (hospitalisation and death rates) and antibody response across intervention groups (including Cornell score, MMSE score, psychiatric diagnosis, and HI titres); To investigate whether Cornell score, MMSE score and HLA type differentially predict clinical response (hospitalisation and death rates) and antibody response to the intervention versus control.
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Lay summary
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Ethics approval
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Received from South London And Maudsley Research Ethics Committee (ref: 04/045)
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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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Influenza
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Participants - inclusion criteria
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All consenting/assenting individuals in care homes with nursing care who receive their primary care from Lambeth and Southwark primary care trusts (PCTs), who would ordinarily receive the influenza vaccine are eligible for inclusion in the trial.
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Participants - exclusion criteria
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If an individual has had a reaction to the initial flu vaccine or if the flu vaccine is contra-indicated in that individual, then they will be excluded from the trial.
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Anticipated start date
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01/08/2004
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Anticipated end date
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31/07/2005
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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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277
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Interventions
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Randomised into immediate assay of 21-day haemagglutination inhibition (HAI) antibody response to flu vaccine, and administration of booster if antibody response inadequate, as compared to treatment as usual.
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Primary outcome measure(s)
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Hospitalisation (Yes/No) between randomisation and 30th April 2005.
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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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Charitable Foundation of Guy's and St. Thomas' (UK) (R031166)
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Trial website
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Publications
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2007 results in http://www.ncbi.nlm.nih.gov/pubmed/18081669
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Contact name
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Dr
Fiona
Gaughran
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Address
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Consultant Psychiatrist and Hon. Senior Lecturer
Adult Mental Health
Ladywell Unit
South London and Maudsley NHS Trust
University Hospital Lewisham
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City/town
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London
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Zip/Postcode
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SE13 6LW
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Country
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United Kingdom
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Sponsor
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South London And Maudsley NHS Trust (UK)
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Address
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Dr. Gill Dale
Assistant Director of Research & Development
(Institute of Psychiatry/South London & Maudsley NHS Trust)
Research & Development Office (P005)
Room W108
Institute of Psychiatry
King's College London
De Crespigny Park
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City/town
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London
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Zip/Postcode
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SE5 8AF
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Country
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United Kingdom
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Tel
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+44 (0)20 7848 0675
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Fax
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+44 (0)20 7848 0147
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Email
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G.Dale@iop.kcl.ac.uk
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Date applied
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26/07/2004
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Last edited
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14/09/2009
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Date ISRCTN assigned
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05/10/2004
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