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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12 December 2020 |
Main ID: |
NCT02712424 |
Date of registration:
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14/03/2016 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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DAR-901 TB Booster Vaccine to Prevent TB in Adolescents
DAR-PIA |
Scientific title:
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A Phase 2, Randomized, Placebo-Controlled, Double-Blind, Study of the Prevention of Infection With Mycobacterium Tuberculosis Among Adolescents Who Have Previously Received BCG |
Date of first enrolment:
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March 2016 |
Target sample size:
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650 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02712424 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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Tanzania
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Contacts
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Name:
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C Fordham von Reyn, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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Dartmouth-Hitchcock Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria: Negative IGRA at baseline -
Exclusion Criteria: Pregnancy, serious underlying disease
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Age minimum:
13 Years
Age maximum:
15 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Tuberculosis
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Intervention(s)
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Biological: DAR-901
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Biological: Sterile saline placebo
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Primary Outcome(s)
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New infection with Mycobacterium tuberculosis
[Time Frame: 2 years]
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Secondary Outcome(s)
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Persistent new infection with M. tuberculosis
[Time Frame: 2 years]
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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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