A Phase 3 interventional study of GC3107 and Intradermal BCG SSI inj. in BCG Vaccination Reaction and Tuberculosis, sponsored by Green Cross Corporation. Completed at 2 sites in Korea, Republic of. Open to participants aged Up to 4 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-02.
Sponsored by Green Cross Corporation · Phase 3, Interventional, and Prevention
The purpose of this study is to investigate the efficacy and safety of GC3107 in healthy infants
The study will be conducted in 2 Countries, Korea and Thailand. About 750 subjects will be enrolled to this study.
This clinical trial consists of Part 1 to compare the efficacy and safety between the study group and the active control group and Part 2 for the final safety assessment. Subject enrollment for Part 1 and Part 2 will occur at the same time, and subjects who meet the final inclusion/exclusion criteria will be randomized to Part 1 or Part 2 via the IWRS.
When the legally acceptable representative of the subject within 4 weeks after birth consents to participate in the clinical study in writing at Visit 1, the protocol-mandated examination and tests will be performed at each visit, and only the subjects who meet the inclusion/exclusion criteria will be assigned randomization numbers and receive a single intradermal injection of the investigational product. However, the informed consent of the subject's legally acceptable representative for participation in the clinical trial may be obtained between 36 weeks of pregnancy of a subject's mother and Visit 1.
The investigator will instruct the subject's legally acceptable representative to record any adverse events (AEs) occurring after administration of the investigational product to assess the safety of the subject during the study period.
The subjects participating in Part 1 will have the tuberculin skin test at Visit 4 for the efficacy assessment and receive an intradermal injection of 0.1 mL purified protein derivatives (PPD) reagent. Visit 5 will occur within 48 to 72 hours of the PPD reagent injection to check the tuberculin skin test results.
Also, Visit 6 will be conducted as an on-site visit to check for any solicited local AEs (abscess, ulcer, scar, and BCG lymphadenitis) and unsolicited AEs occurring until 6 months (168 days) after administration of the investigational product.
1,170 studies on the registry are indexed under Tuberculosis; 175 are open to participants now.
This study's enrollment of 750 is above the median of 150 across 820 interventional studies indexed under Tuberculosis.
Browse Tuberculosis studies →Green Cross Corporation is the lead sponsor of 63 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Part 1 GC3107(BCG Vaccine) Single intradermal Injection of 0.05 mL into the end of deltoid muscle in outer aspect of upper arm
Biological: GC3107
Part 2 GC3107(BCG Vaccine) Single intradermal Injection of 0.05 mL into the end of deltoid muscle in outer aspect of upper arm
Biological: GC3107
Part 1 Intradermal BCG SSI inj Single intradermal Injection of 0.05 mL into the end of deltoid muscle in outer aspect of upper arm
Biological: Intradermal BCG SSI inj.
Part 2 Intradermal BCG SSI inj Single intradermal Injection of 0.05 mL into the end of deltoid muscle in outer aspect of upper arm
Biological: Intradermal BCG SSI inj.
BCG Vaccine
BCG Vaccine
Proportion of subjects with maximum diameter of induration ≥ 5mm in the tuberculin skin test
Induration diameter measured in the direction perpendicular to the arm.
Time frame: 84 days after administration of the investigational product
Proportion of subjects with maximum diameter of induration <5mm, ≥ 5mm to <10mm and ≥10mm in the tuberculin skin test
Induration diameter measured in the direction perpendicular to the arm.
Time frame: 84 days after administration of the investigational product
Proportion of subjects with maximum diameter of erythema ≥ 5mm in the tuberculin skin test
Erythema diameter measured in the direction perpendicular to the arm.
Time frame: 84 days after administration of the investigational product
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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