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Does the flu shot work in sarcoidosis patients? new study aims to find out

NCT ID NCT01687517

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at whether the seasonal flu vaccine works as well in people with sarcoidosis as it does in healthy people. Researchers gave the flu shot to 190 adults with sarcoidosis and compared their immune response to a group of healthy volunteers. The goal was to see if the vaccine is effective and safe in this patient group, especially for those on steroids or immunosuppressants.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
seasonal influenza vaccine
What this could lead to
If successful, this study could show that the flu vaccine is effective and safe for people with sarcoidosis, supporting current vaccination recommendations.
What could go wrong
This is a completed Phase 3 trial with only 190 participants, so results may not apply to all sarcoidosis patients. The vaccine response may be lower than expected, especially in those on immunosuppressants.

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

190 people

The number who actually took part.

Start date

Oct 2012

Finished

Oct 2014

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 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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 for patients: * Age ≥ 18 and ≤ 65; * Signature of informed consent * Follow-up : six months following the influenza vaccination at D0 * Sarcoidosis diagnosed and histologically proven since at least 6 months * unchanged treatment of Sarcoidosis for at least 3 months, except for the case of a decrease in doses of corticosteroids and at a stable dose of immunosuppressive drugs * Indication for a seasonal influenza vaccination. Existence of one or more of these clinical situations: * pulmonary location (dyspnea, radiological or stage IV pulmonary function tests (PFT) altered with decreased forced vital capacity (FVC), forced expiratory volume average (FEV) or the diffusion of carbon monoxide (TLCO) below 65% of predicted value; * Cardiac impairment confirmed * Central nervous system impairment and / or device and confirmed with clinical impact and abnormal imaging and / or electromyogram- Renal impairment (histologically confirmed) responsible for a decrease in creatinine clearance * disabling Lupus pernio * Sinuso-nasal and / or laryngeal impairment histologically confirmed * Disseminated impairment, ie affecting more than four organs * Dose of corticosteroids ≥to 10 mg per day of the equivalent of prednisone or the necessity of an immunosuppressive therapy (with the exception of Rituximab) to control sarcoidosis- Existence of an associated metabolic disorder * Patients with sarcoidosis and living in a care house * Sarcoidosis occurring in health/nursing staff Inclusion criteria for healthy volunteers * Age ≥ 18 and ≤ 65 years * Signature of informed consent * Lack of underlying disease, especially autoimmune diseases and / or sarcoidosis * Follow-up possible during the six months following the influenza vaccination Exclusion Criteria for all: * Hypersensitivity to the active substances, eggs and one of the excipients of the vaccine * Acute febrile episode in the week prior to vaccination * Count with a documented case of influenza within a week prior to vaccination * Infection with HIV HBV or HCV known, * Current pregnancy or positive urine pregnancy test * Multiple Sclerosis * History of Guillain-Barré * Organ Transplantation * Cancer in the last 3 years * Other vaccination received within 3 weeks prior to the study vaccine injection * Treatment with chemotherapy * Transfusion or immunoglobulin administration during the last 3 months * Co-morbidity requiring biological therapy that specifically targets B cells (eg rituximab) * Patient for which an increase of the treatment is planned in the month following vaccination. * Acute infection in the month prior to vaccination * non affiliated to a health social security system * Participation in another biomedical research for the duration of the study * Individuals deprived of freedom by an administrative or court order

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Hotel-Dieu Hospital

    Paris, 75004, France

More trials for these conditions

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