Ignite Creation Date:
2024-05-06 @ 12:15 PM
Last Modification Date:
2024-10-26 @ 12:56 PM
Study NCT ID:
NCT03718468
Status:
COMPLETED
Last Update Posted:
2019-08-14
First Post:
2018-10-22
Brief Title:
A Study to Evaluate the Safety and Immunogenicity of Quadrivalent Influenza Vaccine
Sponsor:
Medigen Vaccine Biologics Corp
Organization:
Medigen Vaccine Biologics Corp
Study Overview
Official Title:
A Phase III Prospective Randomized Open-Labeled Active-Controlled Multi-Center Study to Evaluate the Safety and Immunogenicity of Quadrivalent Influenza Vaccine GC FLU in Adults Aged 20 to 50
Status:
COMPLETED
Status Verified Date:
2019-08
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 aims to demonstrate the immunogenic efficacy of GC FLU Quadrivalent Pre-filled Syringe inj GC FLU a quadrivalent influenza virus vaccine is non-inferior to the active control Fluarix Tetra This study is designed to be a randomized open-labelled active-controlled parallel phase III study recruiting subjects from multiple study sites
Approximately 840 eligible subjects are planned to enroll in order to obtain 800 evaluable per-protocol subjects Subjects will be randomized and assigned to GC FLU or Fluarix Tetra active control AC group in 11 ratio
Approximately 840 eligible subjects are planned to enroll in order to obtain 800 evaluable per-protocol subjects Subjects will be randomized and assigned to GC FLU or Fluarix Tetra active control AC group in 11 ratio
Detailed Description:
None
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