Viewing Study NCT03947138



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Last Modification Date: 2024-10-26 @ 1:09 PM
Study NCT ID: NCT03947138
Status: COMPLETED
Last Update Posted: 2022-11-02
First Post: 2019-04-29

Brief Title: A Study of GC3107BCG Vaccine in Healthy Infants
Sponsor: Green Cross Corporation
Organization: GC Biopharma Corp

Study Overview

Official Title: A Multi-national Multi-center Randomized Double-Blind Active-Controlled Phase III Study to Investigate the Efficacy and Safety of GC3107BCG Vaccine After Intradermal Administration in Healthy Infants
Status: COMPLETED
Status Verified Date: 2022-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The purpose of this study is to investigate the efficacy and safety of GC3107 in healthy infants
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 inclusionexclusion 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 inclusionexclusion criteria will be assigned randomization numbers and receive a single intradermal injection of the investigational product However the informed consent of the subjects legally acceptable representative for participation in the clinical trial may be obtained between 36 weeks of pregnancy of a subjects mother and Visit 1

The investigator will instruct the subjects 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 01 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None