Ignite Creation Date:
2024-05-06 @ 2:31 AM
Last Modification Date:
2024-10-26 @ 11:20 AM
Study NCT ID:
NCT02067117
Status:
COMPLETED
Last Update Posted:
2014-02-20
First Post:
2014-01-19
Brief Title:
Demonstrate the Lot-to-lot Consistency of 3 Consecutive Batches and to Evaluate the Efficacy and Safety of GC FLUPre-filled Syringe Injection and GC FLUInjection Administration
Sponsor:
Green Cross Corporation
Organization:
GC Biopharma Corp
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2014-02
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 is aimed to confirm the lot-to-lot consistency of 3 consecutive batches of GC FLU Pre-filled Syringe Injection and GC FLU Injection in the lot-to-lot
Detailed Description:
This is a Post-Marketing Multicentre Open Randomized Phase 4 Clinical Study Subjects who gave voluntary written informed consent to participate in the study were screened for eligibility in the study and those who met the eligibility criteria were randomized in the investigational group
An investigator assessed the effectiveness immunogenicity and safety of the study vaccine in each subject during hisher participation in the study
Subjects were randomized Visit 1 into the investigational group according to a randomization table previously generated and were vaccinated with influenza split vaccine GC FLUPre-filled Syringe Injection and GC FLUInjection
12 Assessments for HI titre to each strain of influenza were performed at Visit 1 pre-vaccination and at Visit 3 21 days after vaccination for the efficacy immunogenicity evaluation Picture 1For the safety assessment subject diaries were handed out to subjects who were instructed to record any adverse event emerging ager the receipt of study vaccine
An investigator assessed the effectiveness immunogenicity and safety of the study vaccine in each subject during hisher participation in the study
Subjects were randomized Visit 1 into the investigational group according to a randomization table previously generated and were vaccinated with influenza split vaccine GC FLUPre-filled Syringe Injection and GC FLUInjection
12 Assessments for HI titre to each strain of influenza were performed at Visit 1 pre-vaccination and at Visit 3 21 days after vaccination for the efficacy immunogenicity evaluation Picture 1For the safety assessment subject diaries were handed out to subjects who were instructed to record any adverse event emerging ager the receipt of study vaccine
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