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Can flu shots protect autoimmune patients?

NCT ID NCT01065285

Disease control 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at how well flu vaccines (seasonal and H1N1) work in 234 adults with autoimmune diseases like lupus or vasculitis, some of whom were on steroids or immunosuppressants. Researchers measured antibody levels three weeks after each shot to see if the vaccine provided protection. The goal was to understand if these patients can safely and effectively benefit from flu vaccination.

What this could mean

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

Active substance
Influenza vaccine (seasonal and H1N1)
What this could lead to
If successful, this could show that flu vaccines are effective and safe for people with autoimmune diseases, even those on strong medications.
What could go wrong
This is a completed Phase 4 study, so results are known but may not apply to all autoimmune conditions. The immune response may be weaker in patients 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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

234 people

The number who actually took part.

Start date

Oct 2009

Finished

Feb 2012

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 years and older

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: * Adult patients presenting autoimmune and systemic diseases, * treating or not with steroids, and/or immunosuppressants and/or biotherapies, especially vasculitis, scleroderma, Sjogren's syndrome and systemic lupus (main groups) Exclusion Criteria: * Absence of informed consent * Disease which did not responded to the above criteria * Active infection at time of vaccination * HIV infection * History of Guillain-Barre syndrome * Allergy to one component of the vaccine

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Conditions

The condition(s) this trial relates to.

autoimmune disease connective tissue disorder Sjogren syndrome systemic lupus erythematosus systemic sclerosis vasculitis influenza prevention target

As listed by the trial registrant

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

Autoimmune diseases

Contacts and locations

Locations

  • Hopital Cochin

    Paris, 75014, France

More trials for these conditions

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