Ignite Creation Date:
2024-05-05 @ 11:41 PM
Last Modification Date:
2024-10-26 @ 10:37 AM
Study NCT ID:
NCT01389466
Status:
COMPLETED
Last Update Posted:
2014-11-21
First Post:
2011-06-19
Brief Title:
Study to Evaluate the Safety and Immunogenicity of MG1109 in Healthy Adult Volunteers
Sponsor:
Green Cross Corporation
Organization:
GC Biopharma Corp
Study Overview
Official Title:
Randomized Phase III Study to Evaluate the Safety and Immunogenicity of MG1109Egg-based Pre-pandemic InfluenzaH5N1 Vaccine Administered Intramuscularly in Healthy Adult Volunteers
Status:
COMPLETED
Status Verified Date:
2014-11
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:
This study was designed in two steps with Step 1 a single-center double-blind randomized clinical Pilot study and Step 2 a multi-center single-blind randomized clinical Pivotal study The investigator evaluate the immunogenicity and safety of the investigational vaccine in the subjects during their participation in the study
Detailed Description:
MG1109 is purified inactivated influenza viral antigen
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