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

Immune Response Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01289535
• Other study ID #: 2010.621
• 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

• Immune Response

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