Study to Investigate the Safety and Efficacy of GC3107 (BCG Vaccine) in Healthy Adults

Green Cross Corporation20 enrolled

Overview

Healthy adults will be once administered GC3107(BCG Vaccine) Intradermally.

Healthy adults will be once administered GC3107(BCG Vaccine) Intradermally. Tuberculin Skin Test(TST) will be conducted after 84+7 days after IP injection and TST result will be read in 48\~72 hours.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Tuberculosis

Interventions

GC3107BIOLOGICAL

BCG Vaccine, 0.1mL

Eligibility

Sex: ALLMin age: 19 YearsMax age: 64 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy adults aged 19-64 years old * 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 have positive results(;induration diameter over 5mm) in Tuberculin Skin Test(TST) at screening * 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

Locations (1)

Korea University Guro Hospital

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

Adverse Event

Solicited/Unsolicited Adverse Event

Time frame: for 7 days from Day0/during study period

Secondary Outcomes

Whether the maximum Induration diameter greater than 5mm after TST.

Induration diameter measured in the direction perpendicular to the arm.

Time frame: Day0+84days

Whether the maximum Erythema/Redness diameter greater than 5mm after TST.

Erythema/Redness diameter measured in the direction perpendicular to the arm.

Time frame: Day0+84days

Maximum diameter of Induration after TST.

Induration diameter measured in the direction perpendicular to the arm.

Time frame: Day0+84days

Maximum diameter of Erythema/Redness after TST.

Erythema/Redness diameter measured in the direction perpendicular to the arm.

Time frame: Day0+84days

Maximum diameter variation of Induration after TST.

Induration diameter measured in the direction perpendicular to the arm.

Time frame: Day0+84days

Maximum diameter variation of Erythema/Redness after TST.

Erythema/Redness diameter measured in the direction perpendicular to the arm.

Time frame: Day0+84days

Central Contacts

Yoonjung Nam, Pharm.D

CONTACT

+81-260-9143 clairenam@greencross.com

Data from ClinicalTrials.gov

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