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Efficacy Safety Study of Flu Vaccine in Immunodepression Patients

NCT01022749 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 228

Last updated 2025-11-20

No results posted yet for this study

Summary

The primary purpose of the study is to compare the efficacy and safety of influenza vaccine in patients with inflammatory bowel disease (IBD) receiving immunosuppressive therapy with patients not receiving immunosuppressants .

The main objective of the study is to evaluate the humoral immunogenicity of influenza vaccination in patients with IBD

Conditions

  • Inflammatory Bowel Disease (IBD)

Interventions

DRUG

Vaccine

MUTAGRIP (2009-2010 winter) VAXIGRIP (2010-2011 winter)

BIOLOGICAL

Vaccine anti-H1N1

patients who received the vaccine anti-H1N1

Sponsors & Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

    collaborator OTHER_GOV

  • University of Paris 5 - Rene Descartes

    collaborator OTHER

  • Pierre and Marie Curie University

    collaborator OTHER

  • Institut Pasteur

    collaborator INDUSTRY

  • URC-CIC Paris Descartes Necker Cochin

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Odile LAUNAY, MD PhD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2011-07-31
Completion
2013-07-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01022749 on ClinicalTrials.gov