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Immune Response Analysis to Influenza Vaccine in Elderly Aged Over 65 Years (Expand IDWP21)

This study is currently recruiting participants.
Verified December 2011 by Hospices Civils de Lyon
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01289535
First received: February 2, 2011
Last updated: December 29, 2011
Last verified: December 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Immune Response
 Procedure: Blood sample
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Immune Response Analysis to Influenza Vaccine in Elderly Aged Over 65 Years

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • antibody rates after influenza vaccination [ Time Frame: up to 3 months after vaccination ] [ Designated as safety issue: No ]

Estimated Enrollment: 750
Study Start Date: November 2010
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: antibody rates Procedure: Blood sample
Blood sample of 7 ml

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01289535

Contacts
Contact: Catherine GOUJON, Dr +33 478 86 41 25 catherine.goujon@chu-lyon.fr

Locations
France
Unité de Recherche Clinique en Immunologie Lyon Sud (URCI-LS) et Service d'Immunologie clinique et allergologie Recruiting
Pierre-Bénite, France, 69495
Contact: Catherine GOUJON, Dr     +33 478 86 41 25     catherine.goujon@chu-lyon.fr    
Principal Investigator: Catherine GOUJON, Dr            
Sponsors and Collaborators
Hospices Civils de Lyon
  More Information

No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01289535     History of Changes
Other Study ID Numbers: 2010.621
Study First Received: February 2, 2011
Last Updated: December 29, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hospices Civils de Lyon:
Influenza vaccine
immune response
elderly

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 18, 2013