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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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12 December 2020 |
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Main ID: |
NCT00828997 |
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Date of registration:
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23/01/2009 |
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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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Effects of Different Antirheumatic Treatments of Arthritis on Antibody Response Following Vaccination Using Prevenar®
PVA |
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Scientific title:
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Effects of Different Anti-rheumatic Treatments of Arthritis on Antibody Response Following Pneumococcal Vaccination Using Prevenar® |
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Date of first enrolment:
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August 2008 |
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Target sample size:
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505 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00828997 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Meliha C Kapetanovic, MD,PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Dept of Rheumatology, Lund University Hospital, Lund, Sweden |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age > 18 years
- Clinical diagnosis of RA or spondylarthropathy
Exclusion Criteria:
- Pregnancy
- Allergy
- Has received pneumococcal vaccination within 5 years
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis
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Spondylarthropathy
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Intervention(s)
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Biological: Prevenar vaccination
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Primary Outcome(s)
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Serological responses to at least 2 pneumococcal serotypes included in Prevenar vaccine between different treatment groups.
[Time Frame: 2009]
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Secondary Outcome(s)
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to analyse if the result is different compared to the one seen after immunizing with 23-valent nonconjugated pneumococcal polysaccharide vaccine.
[Time Frame: 2009]
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Secondary ID(s)
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EU-nr 2007-006539-29
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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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