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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01289535
Other study ID # 2010.621
Secondary ID
Status Recruiting
Phase Phase 4
First received February 2, 2011
Last updated December 29, 2011
Start date November 2010
Est. completion date April 2012

Study information

Verified date December 2011
Source Hospices Civils de Lyon
Contact Catherine GOUJON, Dr
Phone +33 478 86 41 25
Email catherine.goujon@chu-lyon.fr
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 750
Est. completion date April 2012
Est. primary completion date April 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 65 Years and older
Eligibility 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Procedure:
Blood sample
Blood sample of 7 ml

Locations

Country Name City State
France Unité de Recherche Clinique en Immunologie Lyon Sud (URCI-LS) et Service d'Immunologie clinique et allergologie Pierre-Bénite

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary antibody rates after influenza vaccination up to 3 months after vaccination No
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