A Study of GC3107(BCG Vaccine) in Healthy Infants

A Multi-national, Multi-center, Randomized, Double-Blind, Active-Controlled, Phase III Study to Investigate the Efficacy and Safety of 'GC3107(BCG Vaccine)' After Intradermal Administration in Healthy Infants

The purpose of this study is to investigate the efficacy and safety of GC3107 in healthy infants

Study Overview

• Status: Completed
• Conditions: Tuberculosis; BCG Vaccination Reaction
• Intervention / Treatment: Biological: GC3107; Biological: Intradermal BCG SSI inj.

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 750
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Suwon, Korea, Republic of
    • The Catholic Universitiy of Korea St. vincent's Hospital
  • Yongin, Korea, Republic of
    • Greencross

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 4 weeks (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subject's legally acceptable representatives had this clinical trial information explained to them and understood it, voluntarily decided participation, and provided informed consent
2. Healthy infants aged≤4weeks
3. Body weight≥2,500g at birth
4. Born after normal gestation(≥37weeks)

Exclusion Criteria:

1. Had contact with patients with a confirmed diagnosis of active pulmonary tuberculosis
2. Any symptoms or signs of active tuberculosis infection or current treatment of tuberculosis at screening
3. History of confirmed tuberculosis
4. Acute fever with tympanic temperature≥38.0 'C within 24 hours prior to administration of the investigational product, or an active infections disease at screening
5. Hypothermia with tympanic temperature<36.0 'C within 24 hours prior to administration of the investigational product
6. Clinically suspected neonatal sepsis
7. Born with severe congenital anomaly that may affect the efficacy or safety result of this clinical trial as judged by the investigator
8. Severe skin disease or burn at the injection site of investigational product
9. The subject's mother had human immunodeficiency virus (HIV)-positive result on prenatal testing

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: GC3107_Part1; 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; BCG Vaccine
EXPERIMENTAL: GC3107_Part2; 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; BCG Vaccine
ACTIVE_COMPARATOR: BCG SSI_Part1; 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.; BCG Vaccine
ACTIVE_COMPARATOR: BCG SSI_Part2; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects with maximum diameter of induration ≥ 5mm in the tuberculin skin test	Induration diameter measured in the direction perpendicular to the arm.	84 days after administration of the investigational product

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	84 days after administration of the investigational product

Collaborators and Investigators

• Sponsor: Green Cross Corporation
• Investigators: Principal Investigator: JongHyun Kim, MD, The Catholic University of Korea St. Vincent's Hospital, Pediatrics

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 6, 2019
• Primary Completion (ACTUAL): June 20, 2022
• Study Completion (ACTUAL): September 6, 2022

Study Registration Dates

• First Submitted: April 29, 2019
• First Submitted That Met QC Criteria: May 10, 2019
• First Posted (ACTUAL): May 13, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 2, 2022
• Last Update Submitted That Met QC Criteria: October 31, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis
• Other Study ID Numbers: GC3107_P3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No