Influenza DiseaseNCT00359554
Influenza Vaccination of Nursing Home Workers.
A study testing VAXIGRIPPE in people with Influenza Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Influenza Disease
- What is being tested?
- VAXIGRIPPE
- How many people
- 4,000 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2006to Oct 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: VAXICOL: Effectiveness of Influenza Vaccination of Nursing Home Workers on Mortality of Nursing Home Residents. A Cluster Randomized Trial.
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.
Read the 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.
- Conditions
- Influenza Disease
- Being tested
- VAXIGRIPPE
- Keywords
- Influenza
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VAXIGRIPPEBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2006 (estimated)
- Study startSep 2006
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Influenza DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,000 participants
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Investigators
- Fabrice CARRAT, MD,, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00359554
- Sponsor's protocol ID
- AOM 05050
- Status last verified
- Feb 2007
- First submitted
- 31 Jul 2006
- Last updated
- 7 Feb 2007
- Results posted
- No
Publications
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.
PubMed 10675165Potter 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.
PubMed 8985189Thomas 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.
PubMed 16631547
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VAXICOL: Effectiveness of Influenza Vaccination of Nursing Home Workers on Mortality of Nursing Home Residents. A Cluster Randomized Trial.
- ClinicalTrials.gov ID
- NCT00359554
- Acronym / sponsor ID
- AOM 05050
- Conditions
- Influenza Disease
- Keywords
- Influenza
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 4,000 participants
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Sep 2006
- Study completion
- Oct 2007
- First posted
- 2 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
- 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).
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VAXIGRIPPE | Biological | – |
Primary outcome
all-cause mortality of residents at one year
2 secondary outcomes
hospitalizations of residents,morbidity of nursing home workers.
A cost-effectiveness ratio of influenza vaccination will be calculated
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2007.
- Background: PubMed 10675165Carman 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.
- Background: PubMed 8985189Potter 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.
- Background: PubMed 16631547Thomas 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabrice CARRAT, MD, principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VAXIGRIPPE in people with Influenza Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Feb 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all-cause mortality of residents at one year. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00359554, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2007.