|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT00359554 |
|
Date of registration:
|
31/07/2006 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Influenza Vaccination of Nursing Home Workers.
|
|
Scientific title:
|
VAXICOL: Effectiveness of Influenza Vaccination of Nursing Home Workers on Mortality of Nursing Home Residents. A Cluster Randomized Trial. |
|
Date of first enrolment:
|
September 2006 |
|
Target sample size:
|
4000 |
|
Recruitment status: |
Terminated |
|
URL:
|
http://clinicaltrials.gov/show/NCT00359554 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
France
| | | | | | | |
|
Contacts
|
|
Name:
|
Fabrice CARRAT, MD, |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Assistance Publique - Hôpitaux de Paris |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
Criteria for nursing home:
- Nursing home whose representative physicians agree to participate, with 50 to 200
residents, located in Paris area, and where the vaccination coverage of nursing home
workers was lower than 40% during the previous influenza season (2005).
Criteria for residents:
- All residents who will be present at start of the influenza season (-2 weeks) or who
will be admitted during the influenza season (+ 2 weeks).
Exclusion Criteria:
- People before 60 years Not presences in the EHPAD at the time of the beginning of the
study (at the moment of the beginning of the epidemic - 2 weeks) or not allowed
before the end of the study (before the end of the epidemic + 4, weeks)
Age minimum:
60 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Influenza Disease
|
|
Intervention(s)
|
|
Biological: VAXIGRIPPE
|
|
Primary Outcome(s)
|
|
all-cause mortality of residents at one year
|
|
Secondary Outcome(s)
|
|
A cost-effectiveness ratio of influenza vaccination will be calculated
|
|
hospitalizations of residents,morbidity of nursing home workers.
|
|
Secondary ID(s)
|
|
AOM 05050
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|