Immune Response Analysis to Influenza Vaccine in Elderly Aged Over 65 Years

NCT ID: NCT01289535

Last Updated: 2011-12-30

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

750 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2012-04-30

Brief Summary

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This study is the first step in a clinical research program that aims to study the immune response to influenza vaccine in the elderly and then to propose a new method of administering the vaccine.

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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Immune Response

Keywords

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Influenza vaccine immune response elderly

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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antibody rates

Group Type EXPERIMENTAL

Blood sample

Intervention Type PROCEDURE

Blood sample of 7 ml

Interventions

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Blood sample

Blood sample of 7 ml

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Subject aged 65 years or over
* 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

* Adjuvanted influenza vaccine (e.g: Fluad, Gripguard)
* 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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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France

Central Contacts

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Catherine GOUJON, Dr

Role: CONTACT

Phone: +33 478 86 41 25

Email: [email protected]

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