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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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16 December 2017 |
Main ID: |
NCT03095326 |
Date of registration:
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15/03/2017 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Pneumococcal Vaccination for Splenectomised Thalassemia Major Patients in Indonesia
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Scientific title:
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Pneumococcal Vaccination for Splenectomised Thalassemia Major Patients in Indonesia |
Date of first enrolment:
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September 1, 2013 |
Target sample size:
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56 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT03095326 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Investigator).
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Phase:
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Phase 4
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Countries of recruitment
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Indonesia
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Contacts
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Name:
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Teny T Sari, M.D, PhD |
Address:
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Telephone:
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Email:
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Affiliation:
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Faculty of Medicine University of Indonesia |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Splenectomised thalassemia patient
Exclusion Criteria:
- non-splenectomised thalassemia patient
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Thalassemia
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Pneumococcal Infection
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Intervention(s)
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Biological: PPV Vaccine
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Biological: PCV Vaccine
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Dietary Supplement: Zinc
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Drug: Sucrose
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Primary Outcome(s)
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Pneumococcal IgG
[Time Frame: week 12]
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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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