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Search / Trial NCT02255227

Anti-pneumococcal Vaccine Strategy in Patients Treated With Immunosuppressants or Biotherapies for CIBD

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE SAINT ETIENNE · Oct 1, 2014

Trial Information

Current as of September 04, 2025

Terminated

Keywords

Vaccination Randomized Anti Pneumococcal Pneumo 23 Prevenar 13 Chronic Inflammatory Bowel Disease

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Patient who have given their written consent in a free and informed consent
  • Patient followed for inflammatory bowel disease (Crohn's disease, ulcerative colitis or indeterminate colitis), and treated for at least 3 months by immunosuppressive therapy and /or biotherapies and in clinical remission for at least 3 months
  • Patient agreeing to participate in the study throughout its duration and accepting the procedures related to the study
  • Contraception that the investigator judges effective for the first 12 months of the trial, with a negative pregnancy test
  • Women not planning to become pregnant in the 12 months following inclusion (M0)
  • Patient with social coverage
  • Exclusion Criteria:
  • Patients vaccinated against pneumo23 for less than 5 years
  • Other vaccination during the month before inclusion
  • Patient develops a febrile illness (at least 37 ° C 5 measured orally) or acute infection in the week before vaccination
  • The patient has a flare up of IBD the day of vaccination (Harvey-Brasdshaw score of at least 6 or CDAI \> 220 for Crohn's disease or Mayo Clinic score of at least 4 for UC and indeterminate colitis)
  • Patients with an ongoing pregnancy the day of vaccination
  • Patient with a known history of neuropathy as Guillain-Barré syndrome.
  • Patients with known infection with HIV and / or HBV (HBsAg positive) and / or HCV
  • Patient with other severe immune deficiency
  • Patients who received immunoglobulin infusions of blood products, or of monoclonal antibodies (except anti-TNF) in the 3 months prior to vaccination
  • Patient institutionalized, or deprived of liberty administrative or judicial
  • Patients treated without immunosuppressive therapy or biotherapies

About Centre Hospitalier Universitaire De Saint Etienne

The Centre Hospitalier Universitaire (CHU) de Saint-Étienne is a leading academic medical center in France, dedicated to advancing healthcare through innovative clinical research and high-quality patient care. With a robust infrastructure that supports a wide range of medical specialties, CHU de Saint-Étienne fosters collaboration between healthcare professionals, researchers, and academic institutions. The center is committed to conducting rigorous clinical trials that adhere to ethical standards and regulatory requirements, aiming to improve treatment outcomes and enhance the overall health of the community. Through its dedication to scientific excellence and patient-centered care, CHU de Saint-Étienne plays a pivotal role in the advancement of medical knowledge and the development of new therapeutic interventions.

Locations

Rouen, , France

Pierre Bénite, , France

Besançon, , France

Saint Etienne, , France

Montpellier, , France

Nice, , France

Amiens, , France

Paris, , France

Patients applied

0 patients applied

Trial Officials

Xavier Roblin, MD

Principal Investigator

CHU SAINT-ETIENNE

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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