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

Primary Purpose

Immune Response

Status
Unknown status
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Blood sample
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Immune Response focused on measuring Influenza vaccine, immune response, elderly

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

antibody rates

Arm Description

Outcomes

Primary Outcome Measures

antibody rates after influenza vaccination

Secondary Outcome Measures

Full Information

First Posted
February 2, 2011
Last Updated
December 29, 2011
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT01289535
Brief Title
Immune Response Analysis to Influenza Vaccine in Elderly Aged Over 65 Years
Acronym
Expand IDWP21
Official Title
Immune Response Analysis to Influenza Vaccine in Elderly Aged Over 65 Years
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Unknown status
Study Start Date
November 2010 (undefined)
Primary Completion Date
April 2012 (Anticipated)
Study Completion Date
April 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune Response
Keywords
Influenza vaccine, immune response, elderly

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
750 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
antibody rates
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Blood sample
Intervention Description
Blood sample of 7 ml
Primary Outcome Measure Information:
Title
antibody rates after influenza vaccination
Time Frame
up to 3 months after vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine GOUJON, Dr
Phone
+33 478 86 41 25
Email
catherine.goujon@chu-lyon.fr
Facility Information:
Facility Name
Unité de Recherche Clinique en Immunologie Lyon Sud (URCI-LS) et Service d'Immunologie clinique et allergologie
City
Pierre-Bénite
ZIP/Postal Code
69495
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine GOUJON, Dr
Phone
+33 478 86 41 25
Email
catherine.goujon@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Catherine GOUJON, Dr

12. IPD Sharing Statement

Learn more about this trial

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

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