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Influenza Vaccination of Nursing Home Workers.

Primary Purpose

Influenza Disease

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
VAXIGRIPPE
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Influenza Disease focused on measuring Influenza

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Hopital Saint Antoine Inserm U707

Outcomes

Primary Outcome Measures

all-cause mortality of residents at one year

Secondary Outcome Measures

hospitalizations of residents,morbidity of nursing home workers.
A cost-effectiveness ratio of influenza vaccination will be calculated

Full Information

First Posted
July 31, 2006
Last Updated
February 6, 2007
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT00359554
Brief Title
Influenza Vaccination of Nursing Home Workers.
Official Title
VAXICOL: Effectiveness of Influenza Vaccination of Nursing Home Workers on Mortality of Nursing Home Residents. A Cluster Randomized Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2007
Overall Recruitment Status
Terminated
Study Start Date
September 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

5. Study Description

Brief Summary
The objective of this study is to demonstrate that influenza vaccination of nursing home workers is an effective intervention for reducing mortality of elderly people.
Detailed Description
Nursing homes will be randomized within each pair in two arms "incentive to vaccinate", and "do-nothing". In the arm "incentive to vaccinate", vaccination campaigns will be carried out with face-to-face interviews of nursing home workers in order to achieve more than 80% of vaccination coverage. In the "do-nothing", nursing home workers will be vaccinated as usual. The main endpoint criterion is all-cause mortality of residents. Population sets will be 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). Onset and end of influenza season will be given by regional influenza surveillance system. Secondary criteria are hospitalizations of residents, morbidity of nursing home workers. A cost-effectiveness ratio of influenza vaccination will be calculated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza Disease
Keywords
Influenza

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4000 (false)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
VAXIGRIPPE
Primary Outcome Measure Information:
Title
all-cause mortality of residents at one year
Secondary Outcome Measure Information:
Title
hospitalizations of residents,morbidity of nursing home workers.
Title
A cost-effectiveness ratio of influenza vaccination will be calculated

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabrice CARRAT, MD,
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Saint Antoine Inserm U707
City
Paris
ZIP/Postal Code
75012
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
10675165
Citation
Carman WF, Elder AG, Wallace LA, McAulay K, Walker A, Murray GD, Stott DJ. Effects of influenza vaccination of health-care workers on mortality of elderly people in long-term care: a randomised controlled trial. Lancet. 2000 Jan 8;355(9198):93-7. doi: 10.1016/S0140-6736(99)05190-9.
Results Reference
background
PubMed Identifier
8985189
Citation
Potter J, Stott DJ, Roberts MA, Elder AG, O'Donnell B, Knight PV, Carman WF. Influenza vaccination of health care workers in long-term-care hospitals reduces the mortality of elderly patients. J Infect Dis. 1997 Jan;175(1):1-6. doi: 10.1093/infdis/175.1.1.
Results Reference
background
PubMed Identifier
16631547
Citation
Thomas RE, Jefferson TO, Demicheli V, Rivetti D. Influenza vaccination for health-care workers who work with elderly people in institutions: a systematic review. Lancet Infect Dis. 2006 May;6(5):273-9. doi: 10.1016/S1473-3099(06)70462-5.
Results Reference
background

Learn more about this trial

Influenza Vaccination of Nursing Home Workers.

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