Influenza vaccine in nursing homes - why doesn't it work?

ISRCTN	ISRCTN28553709
DOI	https://doi.org/10.1186/ISRCTN28553709
Secondary identifying numbers	SL&M Research Ethics Committee 04/045

Submission date: 26/07/2004
Registration date: 05/10/2004
Last edited: 14/09/2009

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 Fiona Gaughran
Scientific

Consultant Psychiatrist and Hon. Senior Lecturer
Adult Mental Health
Ladywell Unit
South London and Maudsley NHS Trust
University Hospital Lewisham
London
SE13 6LW
United Kingdom

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Prevention
Scientific title
Study objectives	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(s)	Received from South London And Maudsley Research Ethics Committee (ref: 04/045)
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)
Primary outcome measure	Hospitalisation (Yes/No) between randomisation and 30th April 2005.
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/08/2004
Completion date	31/07/2005

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Both
Target number of participants	277
Key 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.
Key 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.
Date of first enrolment	01/08/2004
Date of final enrolment	31/07/2005

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Consultant Psychiatrist and Hon. Senior Lecturer

London
SE13 6LW
United Kingdom

Sponsor information

South London And Maudsley NHS Trust (UK)
Hospital/treatment centre

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
England
United Kingdom

Phone	+44 (0)20 7848 0675
Email	G.Dale@iop.kcl.ac.uk
"ROR"	https://ror.org/015803449

Funders

Funder type

Charity

Charitable Foundation of Guy's and St. Thomas' (UK) (R031166)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	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	01/12/2007		Yes	No