CompletedPhase 4

Vaccination Against Influenza in Autoimmune Diseases

France234 participantsStarted 2009-10

Plain-language summary

The project is to evaluate immunogenicity, efficacy and tolerance of vaccination against influenza (seasonal and H1N1) in patients affected with systemic and autoimmune diseases.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Protection against H1N1 influenza, defined by antibody level of 1/40, measured by hemagglutination, 3 weeks after the first injection and after the second injection

Timeframe: 3 weeks

Trial details

NCT IDNCT01065285

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-07

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