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
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 |
---|---|
m.a.gosney@reading.ac.uk |
Study information
Study design | Randomised controlled trial |
---|---|
Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Not Specified |
Scientific title | Cost benefit evaluation of routine influenza immunisation in subjects 65-74 years of age |
Study objectives | 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(s) | Not provided at time of registration. |
Health condition(s) or problem(s) studied | 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 |
Primary outcome measure | 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 study start date | 01/09/1999 |
Completion date | 31/08/2002 |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Senior |
Sex | Both |
Target number of participants | Not provided at time of registration. |
Total final enrolment | 729 |
Key inclusion criteria | 65-74 year olds |
Key exclusion criteria | Aged over 75 years |
Date of first enrolment | 01/09/1999 |
Date of final enrolment | 31/08/2002 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Institute of Health Sciences
Reading
RG1 5AQ
United Kingdom
RG1 5AQ
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
Phone | +44 (0)1132 545 843 |
---|---|
Sheila.Greener@doh.gsi.gov.uk | |
Website | http://www.dh.gov.uk/en/index.htm |
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 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 | 01/02/2003 | Yes | No |
Editorial Notes
10/07/2019: Total final enrolment added.