Study to Investigate the Safety and Efficacy of GC3107 (B... | NCT03363178

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

NCT03363178

Sponsor

Green Cross Corporation

Status

Unknown status

Last Update Posted

Dec 18, 2017Actual

Enrollment

20Estimated

Phase

Phase 1

Conditions

Tuberculosis

Interventions

GC3107

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 14, 2017Actual

Primary Completion Date

Mar 31, 2018Estimated

Completion Date

Mar 31, 2018Estimated

First Submitted Date

Nov 30, 2017

First Submission Date that Met QC Criteria

Nov 30, 2017

First Posted Date

Dec 6, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 15, 2017

Last Update Posted Date

Dec 18, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GC3107	Experimental	BCG Vaccine, 0.1mL	Biological: GC3107

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GC3107	Biological	BCG Vaccine, 0.1mL	GC3107

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse Event	Solicited/Unsolicited Adverse Event	for 7 days from Day0/during study period

Secondary Outcomes

Measure	Description	Time Frame
Whether the maximum Induration diameter greater than 5mm after TST.	Induration diameter measured in the direction perpendicular to the arm.	Day0+84days
Whether the maximum Erythema/Redness diameter greater than 5mm after TST.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yoonjung Nam, Pharm.D	Contact	+81-260-9143		clairenam@greencross.com

Overall Officials

Name	Affiliation	Role
Woo Joo Kim, M.D, Ph.D	Korea University Guro Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Korea University Guro Hospital	Recruiting	Seoul			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014376	Tuberculosis

Ancestor Terms

ID	Term
D009164	Mycobacterium Infections
D000193	Actinomycetales Infections
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections

Browse Leaves

Not provided

Browse Branches

Not provided