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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01289535

Acronym

Expand IDWP21

Enrollment

750

Registered

2011-02-03

Start date

2010-11-30

Completion date

2012-04-30

Last updated

2011-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immune Response

Keywords

Influenza vaccine, immune response, elderly

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.

Interventions

PROCEDUREBlood sample

Blood sample of 7 ml

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
antibody rates after influenza vaccination	up to 3 months after vaccination

Countries

France

Contacts

Primary ContactCatherine GOUJON, Dr

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026