Hopital Cochin
Paris, 75014, France
NCT Number: NCT01065285
The project is to evaluate immunogenicity, efficacy and tolerance of vaccination against influenza (seasonal and H1N1) in patients affected with systemic and autoimmune diseases.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Paris, 75014, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
evaluate efficacy and tolerance
Other names: Evaluation of vaccines against flu in auto-imune diseases
Time frame: 3 weeks
Mesure of antibody level of 1/40, measured by hemagglutination, 3 weeks after the first injection and after the second injection
Time frame: 3 weeks
Antibody levels against H1N1 in the different groups of patients, defined according diseases and their treatment
Time frame: 3 weeks
Time frame: 3 weeks
Time frame: 3 weeks
Time frame: 3 weeks
Time frame: 3 weeks
Time frame: 3 weeks
Time frame: 18 months
Time frame: 18 months
Assistance Publique - Hôpitaux de Paris
Other
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)
Acronym: MAIVAX
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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