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

Phase 4

• Conditions: Immune Response
• Interventions: Procedure: Blood sample

• Registration Number: NCT01289535
• Lead Sponsor: Hospices Civils de Lyon

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2011-02-02
• Study First Submitted QC: 2011-02-02
• Study First Posted: 2011-02-03
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-29
• Last Update Posted: 2011-12-30
• Primary Completion: 2012-04
• Study Completion: 2012-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 750

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
antibody rates	Blood sample	-

Primary Outcome Measures

Name	Time	Method
antibody rates after influenza vaccination	up to 3 months after vaccination

Trial Locations

Locations (1)

Unité de Recherche Clinique en Immunologie Lyon Sud (URCI-LS) et Service d'Immunologie clinique et allergologie; 🇫🇷 Pierre-Bénite, France