Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SL&M Research Ethics Committee 04/045
Study information
Scientific title
Acronym
Study hypothesis
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.
Ethics approval
Received from South London And Maudsley Research Ethics Committee (ref: 04/045)
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Condition
Influenza
Intervention
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.
Intervention type
Biological/Vaccine
Phase
Not Specified
Drug names
Primary outcome measure
Hospitalisation (Yes/No) between randomisation and 30th April 2005.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/08/2004
Overall trial end date
31/07/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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.
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
277
Participant exclusion criteria
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.
Recruitment start date
01/08/2004
Recruitment end date
31/07/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Consultant Psychiatrist and Hon. Senior Lecturer
London
SE13 6LW
United Kingdom
Sponsor information
Organisation
South London And Maudsley NHS Trust (UK)
Sponsor details
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
London
SE5 8AF
United Kingdom
+44 (0)20 7848 0675
G.Dale@iop.kcl.ac.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
Charitable Foundation of Guy's and St. Thomas' (UK) (R031166)
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
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/18081669
Publication citations
-
Results
Gaughran F, Walwyn R, Lambkin-Williams R, Whelan P, Chatterton K, Oxford J, Macdonald A, , Flu: effect of vaccine in elderly care home residents: a randomized trial., J Am Geriatr Soc, 2007, 55, 12, 1912-1920, doi: 10.1111/j.1532-5415.2007.01471.x.