Cost benefit evaluation of routine influenza immunisation in subjects 65-74 years of age

ISRCTN ISRCTN27879030
DOI https://doi.org/10.1186/ISRCTN27879030
Secondary identifying numbers HTA 97/20/06
Submission date
25/04/2003
Registration date
25/04/2003
Last edited
10/07/2019
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 Margot Gosney
Scientific

Institute of Health Sciences
University of Reading
Building 22
1st Floor
London Road
Reading
RG1 5AQ
United Kingdom

Phone +44 (0)118 378 6850
Email m.a.gosney@reading.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific titleCost benefit evaluation of routine influenza immunisation in subjects 65-74 years of age
Study objectivesWe 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(s)Not provided at time of registration.
Health condition(s) or problem(s) studiedInfection and infestations: Influenza
InterventionPlease 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 typeOther
Primary outcome measure1.1 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 measuresNot provided at time of registration.
Overall study start date01/09/1999
Completion date31/08/2002

Eligibility

Participant type(s)Patient
Age groupSenior
SexBoth
Target number of participantsNot provided at time of registration.
Total final enrolment729
Key inclusion criteria65-74 year olds
Key exclusion criteriaAged over 75 years
Date of first enrolment01/09/1999
Date of final enrolment31/08/2002

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Institute of Health Sciences
Reading
RG1 5AQ
United Kingdom

Sponsor information

Department of Health (UK)
Government

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom

Phone +44 (0)1132 545 843
Email Sheila.Greener@doh.gsi.gov.uk
Website http://www.dh.gov.uk/en/index.htm
ROR logo "ROR" https://ror.org/03sbpja79

Funders

Funder type

Government

NIHR Health Technology Assessment Programme - HTA (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/02/2003 Yes No

Editorial Notes

10/07/2019: Total final enrolment added.