Condition category
Infections and Infestations
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
11/05/2009
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 Margot Gosney

ORCID ID

Contact details

Institute of Health Sciences
University of Reading
Building 22
1st Floor
London Road
Reading
RG1 5AQ
United Kingdom
+44 (0)118 378 6850
m.a.gosney@reading.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 97/20/06

Study information

Scientific title

Acronym

Study hypothesis

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.

Please note that, as of 11/05/2009, the anticipated end date has been updated from 31/08/2001 to 31/08/2002.

Ethics approval

Not provided at time of registration.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Infection and infestations: Influenza

Intervention

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.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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.

Secondary outcome measures

Not provided at time of registration.

Overall trial start date

01/09/1999

Overall trial end date

31/08/2002

Reason abandoned

Eligibility

Participant inclusion criteria

65-74 year olds

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

Not provided at time of registration.

Participant exclusion criteria

Aged over 75 years

Recruitment start date

01/09/1999

Recruitment end date

31/08/2002

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Institute of Health Sciences
Reading
RG1 5AQ
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/en/index.htm

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK)

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

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=14499051

Publication citations

  1. Allsup S, Gosney M, Haycox A, Regan M, Cost-benefit evaluation of routine influenza immunisation in people 65-74 years of age., Health Technol Assess, 2003, 7, 24, iii-x, 1-65.

Additional files

Editorial Notes