Condition category
Infections and Infestations
Date applied
26/07/2004
Date assigned
05/10/2004
Last edited
14/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Fiona Gaughran

ORCID ID

Contact details

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

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 measures

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

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

Results - basic reporting

Publication summary

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/18081669

Publication citations

  1. 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.

Additional files

Editorial Notes