NCT03947138

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
750

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Aug 2019

Typical duration for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 13, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

August 6, 2019

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 6, 2022

Completed
Last Updated

November 2, 2022

Status Verified

October 1, 2022

Enrollment Period

2.9 years

First QC Date

April 29, 2019

Last Update Submit

October 31, 2022

Conditions

BCG Vaccination ReactionTuberculosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Proportion of subjects with maximum diameter of induration <5mm, ≥ 5mm to <10mm and ≥10mm in the tuberculin skin test

    84 days after administration of the investigational product

  • Proportion of subjects with maximum diameter of erythema ≥ 5mm in the tuberculin skin test

    84 days after administration of the investigational product

Study Arms (4)

GC3107_Part1

EXPERIMENTAL

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

GC3107_Part2

EXPERIMENTAL

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 SSI_Part1

ACTIVE COMPARATOR

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 SSI_Part2

ACTIVE COMPARATOR

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.

Interventions

GC3107BIOLOGICAL

BCG Vaccine

GC3107_Part1GC3107_Part2
Intradermal BCG SSI inj.BIOLOGICAL

BCG Vaccine

BCG SSI_Part1BCG SSI_Part2

Eligibility Criteria

AgeUp to 4 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Catholic Universitiy of Korea St. vincent's Hospital

Suwon, South Korea

Location

Greencross

Yŏngin, South Korea

Location

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • JongHyun Kim, MD

    The Catholic University of Korea St. Vincent's Hospital, Pediatrics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2019

First Posted

May 13, 2019

Study Start

August 6, 2019

Primary Completion

June 20, 2022

Study Completion

September 6, 2022

Last Updated

November 2, 2022

Record last verified: 2022-10

Locations

KR(2)