Influenza Vaccination of Nursing Home Workers.

Influenza Disease Clinical Trial

Official title:

VAXICOL: Effectiveness of Influenza Vaccination of Nursing Home Workers on Mortality of Nursing Home Residents. A Cluster Randomized Trial.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00359554
• Other study ID #: AOM 05050
• Status: Terminated
• Phase: N/A
• First received: July 31, 2006
• Last updated: February 6, 2007
• Start date: September 2006
• Est. completion date: October 2007

Study information

• Verified date: February 2007
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4000
• Est. completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Influenza Disease
• Influenza, Human

Intervention

Biological:
• VAXIGRIPPE

Locations

Country	Name	City	State
France	Hopital Saint Antoine Inserm U707	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (3)

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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all-cause mortality of residents at one year
Secondary	hospitalizations of residents,morbidity of nursing home workers.
Secondary	A cost-effectiveness ratio of influenza vaccination will be calculated