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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01151644 |
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Date of registration:
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25/06/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Safety and Efficacy of Anti-Pandemic H1N1 Vaccination in Rheumatic Diseases
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Scientific title:
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Safety and Efficacy of Anti-Pandemic H1N1 Vaccination in Rheumatic Diseases |
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Date of first enrolment:
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April 2010 |
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Target sample size:
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5000 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01151644 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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Phase:
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Phase 4
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Countries of recruitment
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Brazil
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Rheumatic diseases according to international criteria of each disorder
Exclusion Criteria:
- 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
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Juvenile SLE
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Rheumatoid Arthritis
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DMixed Connective Tissue Disease
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Sjögren's Syndrome
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Systemic Vasculitis
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Systemic Sclerosis (SSc)
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Spondyloarthritis
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Dermatomyositis (DM)
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Juvenile DM
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Antiphospholipid Syndrome
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Juvenile Idiopathic Arthritis
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Systemic Lupus Erythematosus (SLE)
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Intervention(s)
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Biological: Anti-pandemic H1N1 influenza vaccine
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Primary Outcome(s)
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Safety (adverse effects) and efficacy (serconversion rate) after 21 days from the vaccination
[Time Frame: Before and after 21 days from vaccination]
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Secondary ID(s)
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CEDMAC-H1N1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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