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

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ClinicalTrials.gov Identifier: NCT01289535
Recruitment Status : Unknown
Verified December 2011 by Hospices Civils de Lyon.
Recruitment status was:  Recruiting
First Posted : February 3, 2011
Last Update Posted : December 30, 2011
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Immune Response Procedure: Blood sample Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Immune Response Analysis to Influenza Vaccine in Elderly Aged Over 65 Years
Study Start Date : November 2010
Estimated Primary Completion Date : April 2012
Estimated Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: antibody rates Procedure: Blood sample
Blood sample of 7 ml




Primary Outcome Measures :
  1. antibody rates after influenza vaccination [ Time Frame: up to 3 months after vaccination ]


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01289535     History of Changes
Other Study ID Numbers: 2010.621
First Posted: February 3, 2011    Key Record Dates
Last Update Posted: December 30, 2011
Last Verified: December 2011

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
Vaccines
Immunologic Factors
Physiological Effects of Drugs