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

• Sponsor: Hospices Civils de Lyon (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01289535
• Collaborator: (none)
• Enrollment: 750
• Location: 1
• Arm: 1
• Duration (Months): 17
• Patients Per Site Per Month: 44.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Immune Response	Procedure: Blood sample	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 750 participants
• Allocation: N/A
• 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: Nov 1, 2010
• Anticipated Primary Completion Date: Apr 1, 2012
• Anticipated Study Completion Date: Apr 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. antibody rates after influenza vaccination [up to 3 months after vaccination]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Unité de Recherche Clinique en Immunologie Lyon Sud (URCI-LS) et Service d'Immunologie clinique et allergologie	Pierre-Bénite		France	69495

Sponsors and Collaborators

• Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hospices Civils de Lyon
• ClinicalTrials.gov Identifier: NCT01289535
• Other Study ID Numbers: 2010.621
• First Posted: Feb 3, 2011
• Last Update Posted: Dec 30, 2011
• Last Verified: Dec 1, 2011

• Keywords provided by Hospices Civils de Lyon: Influenza vaccine; immune response; elderly
• Additional relevant MeSH terms: Influenza, Human

Study Results

No Results Posted as of Dec 30, 2011