Influenza Vaccination of Nursing Home Workers.

This study has been terminated.
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00359554
First received: July 31, 2006
Last updated: February 6, 2007
Last verified: February 2007
  Purpose

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.


Condition Intervention
Influenza Disease
Biological: VAXIGRIPPE

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: VAXICOL: Effectiveness of Influenza Vaccination of Nursing Home Workers on Mortality of Nursing Home Residents. A Cluster Randomized Trial.

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

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

Estimated Enrollment: 4000
Study Start Date: September 2006
Estimated Study Completion Date: October 2007
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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00359554

Locations
France
Hopital Saint Antoine Inserm U707
Paris, France, 75012
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Fabrice CARRAT, MD, Assistance Publique - Hôpitaux de Paris
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00359554     History of Changes
Other Study ID Numbers: AOM 05050
Study First Received: July 31, 2006
Last Updated: February 6, 2007
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Influenza

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 23, 2014