NCT01065285

Vaccination Against Influenza in Autoimmune Diseases

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)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 234 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This prospective study concentrates on patients with vasculitis, systemic sclerosis, Sjögren's syndrome, systemic lupus erythematosus and other connective tissue diseases. Patients responding to the inclusion criteria, will receive vaccine against seasonal influenza then, 3 weeks later, vaccine against H1N1 influenza. According to the results of ongoing trials a second injection of H1N1 vaccine has been scheduled 3 weeks later. At each consultation a blood sample will be taken to evaluate immunogenicity of vaccination. Two additional consultations have been scheduled: one month after the last vaccine administration and at 6 month, in order to evaluate the occurrence of late side effects.

Conditions

• Autoimmune Diseases

Interventions

Type	Name	Description
BIOLOGICAL	Evaluation of vaccines against flu	evaluate efficacy and tolerance

Timeline

• Start date: 2009-10-01
• Primary completion: 2011-07-01
• Completion: 2012-02-01
• First posted: 2010-02-09
• Last updated: 2025-11-20

Locations

1 site across 1 country: France