Study to Investigate the Safety and Efficacy of GC3107 (BCG Vaccine) in Healthy Adults
NCT ID: NCT03363178
Last Updated: 2017-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
20 participants
INTERVENTIONAL
2017-12-14
2018-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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GC3107
BCG Vaccine, 0.1mL
GC3107
BCG Vaccine, 0.1mL
Interventions
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GC3107
BCG Vaccine, 0.1mL
Eligibility Criteria
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Inclusion Criteria
* Informed consent form has been signed and dated
* Able to comply with the requirements of the study
* Female subjects who have negative results in Urine hCG test at screening, or menopausal women.
Exclusion Criteria
* Subjects who shown abnormal results(including inactive tuberculosis) on Chest X-ray at screening
* Subjects who received a vaccination(including live vaccine) within 28 days before enrollment
* Subjects who are on antituberculosis drugs
* Immunocompromised subjects with immunodeficiency disease or subjects receiving immunosuppressive or immunomodulating therapy
* Subjects with severe chronic disease who are considered by investigator to be ineligible for the study
* Pregant or lactating women
19 Years
64 Years
ALL
Yes
Sponsors
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Green Cross Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Woo Joo Kim, M.D, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Korea University Guro Hospital
Locations
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Korea University Guro Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Woo Joo Kim, M.D. Ph.D.
Role: primary
Other Identifiers
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GC3107_P1
Identifier Type: -
Identifier Source: org_study_id