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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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10 April 2023 |
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Main ID: |
NCT03762824 |
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Date of registration:
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03/12/2018 |
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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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Combined Pneumococcal Conjugate and Polysaccharide Vaccination in Inflammatory Rheumatic Disease
IPS-BOOSTER |
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Scientific title:
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Combined Pneumococcal Conjugate and Polysaccharide Vaccination in Inflammatory Rheumatic Disease. Impact of Antirheumatic Treatment on Antibody Response. |
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Date of first enrolment:
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June 14, 2016 |
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Target sample size:
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300 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03762824 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
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Phase:
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Phase 4
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Contacts
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Name:
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Jehns Martineus, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Skåne Universitets sjukhus, dept of rheumatology |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Adult patients with IRD receiving active anti-rheumatic treatments with DMARDs or
biological remedies are offered to participate in the study. The protocol permits
stratification for prednisolone usage.
Exclusion Criteria:
- known allergy/intolerance of pneumococcal vaccine
- pregnancy
- active infection
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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Spondyloarthritis
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Rheumatoid Arthritis
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Systemic Lupus
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Sjögren Syndrome
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Systemic Vasculitis
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Intervention(s)
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Biological: 13-valent pneumococcal conjugate vaccine
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Biological: 23-valent pneumococcal polysaccharide vaccine
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Primary Outcome(s)
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2-fold rise in pneumococcal serotype-specific antibody concentration
[Time Frame: 8 weeks after pneumococcal conjugate vaccine and 4-6 weeks after polysaccharide vaccination]
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Secondary Outcome(s)
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Functional antibody response
[Time Frame: 8 weeks after pneumococcal conjugate vaccine and 4-6 weeks after polysaccharide vaccination]
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Long-term serotype-specific immunity to pneumococcal disease
[Time Frame: 3 years after vaccination]
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Secondary ID(s)
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IPS-BOOSTER
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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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