Status:
UNKNOWN
Safety and Efficacy of Anti-Pandemic H1N1 Vaccination in Rheumatic Diseases
Lead Sponsor:
University of Sao Paulo
Collaborating Sponsors:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conditions:
Rheumatoid Arthritis
Spondyloarthritis
Eligibility:
All Genders
Phase:
PHASE4
Brief Summary
The prognosis of rheumatic diseases has improved considerably with development of therapy. However, infections are considered the most important cause of morbidity and mortality in this group of patie...
Eligibility Criteria
Inclusion
- Rheumatic diseases according to international criteria of each disorder
Exclusion
- Previous and confirmed infection by virus A(H1N1)/2009
- History of anaphylatic reaction to egg components
- Acute fever
- Guillain-Barré syndrome, heart failure (classes III or IV), demyelinating disease
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2010
Estimated Enrollment :
5000 Patients enrolled
Trial Details
Trial ID
NCT01151644
Start Date
April 1 2010
End Date
December 1 2010
Last Update
June 28 2010
Active Locations (1)
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1
Rheumatology Division of Hospital das Clínicas da Faculdade de Medicina da Universidade de são PAulo
São Paulo, São Paulo, Brazil