NCT00359554

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2006

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 2, 2006

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

February 7, 2007

Status Verified

February 1, 2007

First QC Date

July 31, 2006

Last Update Submit

February 6, 2007

Conditions

Keywords

Influenza

Outcome Measures

Primary Outcomes (1)

  • all-cause mortality of residents at one year

Secondary Outcomes (2)

  • hospitalizations of residents,morbidity of nursing home workers.

  • A cost-effectiveness ratio of influenza vaccination will be calculated

Interventions

VAXIGRIPPEBIOLOGICAL

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Saint Antoine Inserm U707

Paris, 75012, France

Location

Related 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. doi: 10.1016/S0140-6736(99)05190-9.

    PMID: 10675165BACKGROUND
  • 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.

    PMID: 8985189BACKGROUND
  • 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.

    PMID: 16631547BACKGROUND

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Fabrice CARRAT, MD,

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 31, 2006

First Posted

August 2, 2006

Study Start

September 1, 2006

Study Completion

October 1, 2007

Last Updated

February 7, 2007

Record last verified: 2007-02

Locations