Ignite Creation Date:
2024-05-06 @ 3:14 AM
Last Modification Date:
2024-10-26 @ 11:31 AM
Study NCT ID:
NCT02249221
Status:
COMPLETED
Last Update Posted:
2014-12-05
First Post:
2014-09-23
Brief Title:
Safety Tolerability and Immunogenicity of GC3106 Quadrivalent Cell-culture Based Influenza Vaccine
Sponsor:
Green Cross Corporation
Organization:
GC Biopharma Corp
Study Overview
Official Title:
A Randomized Part B Open-label Part A or Double-blind Part B Active-controlled Part B Phase IIIa Study to Investigate the Safety Tolerability and Immunogenicity of GC3106 Quadrivalent Cell-culture Based Influenza Vaccine
Status:
COMPLETED
Status Verified Date:
2014-12
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 evaluate the safety tolerability and immunogenicity of GC3106 after single intramuscular administration in Korean healthy adults
Detailed Description:
This study is the first in human trial of GC3106 and is designed as an adaptive Phase IIIa to ensure participants protection Part A is an open-label and single arm study in 9 healthy volunteers Data and Safety Monitoring Board DSMB will review the solicitedunsolicited adverse events conditionally if any toxicity of Grade 3 or 4 has been reported during 7 days after vaccination from the first 9 healthy volunteers Part B is a randomized 21 double-blind active controlled study and a total of 75 volunteers will participate in this part Adverse events assessment will be done according to the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None