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Does the flu shot work in IBD patients on immune drugs?

NCT ID NCT01022749

Knowledge-focused Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested how well the flu vaccine works and if it's safe for people with inflammatory bowel disease (IBD). Researchers compared 228 adults with IBD who were either taking immunosuppressive drugs or not. The goal was to see if the vaccine triggers a strong immune response in both groups.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

228 people

The number who actually took part.

Start date

Sep 2009

Finished

Jul 2013

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 64 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria : * informed consent signed * Age between 18 to 64 * Patient suffering from chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis, or indeterminate colitis) * For patients receiving at least one immunosuppressive or anti-TNF therapy: treatment introduced for at least 3 months * Patient willing to participate in the study throughout its duration and acceptance procedures related to the study (blood samples, self questionnaires, nasal swab and telephone follow-up) Exclusion criteria : * Patient treated by corticosteroid alone without immunosuppressive or anti-TNF * For women, being pregnant or positive pregnancy test * Known allergy to any component of the study vaccine or a history of hypersensitivity reaction to influenza vaccination * Fever (at least 37.5°C measured orally) or acute infection in the week prior to vaccination * Received influenza vaccination in the 6 months preceding enrollment * Known history of progressive neuropathy or Guillain-Barre * Known infection with HIV and/or HBV (Ag-HBs positive) and/or HCV * Other causes of severe immune deficiency * Cellular therapy, immunoglobulin infusions, of blood products or monoclonal antibodies (except anti-TNF) in the 3 months prior to vaccination * Patient deprived of freedom by an administrative or court order * Patient non affiliated to a health social security system

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Conditions

The condition(s) this trial relates to.

Crohn disease indeterminate colitis inflammatory bowel disease ulcerative colitis influenza prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Inflammatory bowel disease (IBD)

Contacts and locations

Locations

  • CIC Vaccinologie Hopital Cochin

    Paris, 75014, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.