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

NCT01289535 | Unknown Phase 4

• 1 other identifier: 2010.621
• Study Type: interventional
• Target: 750
• Locations: 1 country
• Sites: 1

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.

Conditions

Immune Response

Keywords

Influenza vaccine; immune response; elderly

Outcome Measures

Primary Outcomes (1)

• antibody rates after influenza vaccination

  up to 3 months after vaccination

Study Arms (1)

antibody rates

EXPERIMENTAL

Procedure: Blood sample

Interventions

Blood sample PROCEDURE

Blood sample of 7 ml

antibody rates

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Subject aged 65 years or over
• Legal capacity to consent
• Subject had given written consent before his participation

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Unité de Recherche Clinique en Immunologie Lyon Sud (URCI-LS) et Service d'Immunologie clinique et allergologie

Pierre-Bénite, 69495, France

RECRUITING

MeSH Terms

Conditions

Influenza, Human

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Catherine GOUJON, Dr

CONTACT

+33 478 86 41 25; catherine.goujon@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2011
• First Posted: February 3, 2011
• Study Start: November 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: December 30, 2011

Record last verified: 2011-12

Locations

FR (1)