Evaluation of Vaccination Against Influenza (Seasonal and H1N1) in Patients Presenting Systemic or Autoimmune Diseases Treated or Not With Steroids, and/or Immunosuppressant, and/or Biotherapy: an Open, Prospective Trial (MAIVAX)

NCT01065285 Phase 4 COMPLETED

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

Details

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Phase	Phase 4
Status	COMPLETED
Enrolment	234
Start date	2009-10
Completion	2012-02

Conditions

• Autoimmune Diseases

Interventions

• Evaluation of vaccines against flu

Primary outcomes

• 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 — 3 weeks
  Mesure of antibody level of 1/40, measured by hemagglutination, 3 weeks after the first injection and after the second injection

Countries

France