Immune Response Analysis to Influenza Vaccine in Elderly Aged Over 65 Years
NCT ID: NCT01289535
Last Updated: 2011-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
750 participants
INTERVENTIONAL
2010-11-30
2012-04-30
Brief Summary
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Influenza can cause severe complications in patients at risk (elderly and subjects vulnerable because of a chronic underlying disease). Over 90% of deaths related to influenza occur in people aged over 65 years.
Vaccination is the most effective way to prevent infection. The World Health Organization recommends annual immunization for people at risk, including all persons aged over 65 years, to reduce the risk of morbidity and mortality related to influenza.
However, the immune response to influenza vaccine appears to be lower in elderly than in young people.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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antibody rates
Blood sample
Blood sample of 7 ml
Interventions
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Blood sample
Blood sample of 7 ml
Eligibility Criteria
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Inclusion Criteria
* Influenza vaccination without adjuvant, within 3 weeks and 3 months before inclusion visit
* Legal capacity to consent
* Subject had given written consent before his participation
Exclusion Criteria
* Live vaccines within 3 weeks before and after influenza vaccination
* Inactivated vaccines within 2 weeks before and after influenza vaccination
* Chronic disease non-stabilized under treatment
* Severe malnutrition in the opinion of the investigator
* Congenital immunodeficiency
* Chemotherapy or radiotherapy over the last 6 months
* Immunosuppressive therapy or corticosteroid (daily dose of prednisone or equivalent \>/= 20 mg/d over 14 days) from 1 month before vaccination until the study visit
* Participation in another clinical study that could interfere with the present study
65 Years
ALL
Yes
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Locations
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Unité de Recherche Clinique en Immunologie Lyon Sud (URCI-LS) et Service d'Immunologie clinique et allergologie
Pierre-Bénite, , France
Countries
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Central Contacts
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Facility Contacts
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Catherine GOUJON, Dr
Role: primary
Other Identifiers
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2010.621
Identifier Type: -
Identifier Source: org_study_id