Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2025-12-31 @ 8:01 AM
Study NCT ID:
NCT02330003
Status:
COMPLETED
Last Update Posted:
2015-01-01
First Post:
2014-12-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 1 Study to Assess the Safety of Inactivated Split Influenza Vaccine and Control Vaccine in Korean Volunteer
Sponsor:
Il-Yang Pharm. Co., Ltd.
Organization:
Study Overview
Official Title:
A Randomized, Active-Comparator, Open-Label, Phase 1 Clinical Trial to Assess the Safety of the 'IL-YANG Inactivated Split Influenza Vaccine' and Fluarix Prefilled Syringe in Healthy Korean Male Volunteer
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 to evaluate the safety of IL-YANG Inactivated Split Influenza Vaccine (IL-YANG FLU Vaccine Prefilled Syringe INJ.) in comparison with Fluarix Prefilled Syringe (inactivated split influenza vaccine) after single-dose intramuscular administration.
Detailed Description:
This was a randomized, open-label, active-controlled clinical study. After providing voluntary written informed consent, subjects underwent protocol-specific assessments and tests within the 4 weeks prior to administration of the study vaccine, and those who met all of the inclusion/exclusion criteria were randomized sequentially to the test group or the comparator group according to the pre-generated randomization code. To investigate the safety of the study drug with a two-dose regimen in children, the test group received another dose 28 days after the first dose.
The investigator evaluated the safety and immunogenicity for each subject throughout the study. Safety assessments were performed 28 days after the first dose (Visit 4, End-of-Study Visit) for the comparator group receiving a single-dose regimen of Fluarix Prefilled Syringe, and for the test group receiving a two-dose regimen of the test drug, 28 days after the first dose (Visit 4) and 28 days after the second dose (Visit 6, End-of-Study Visit). Subjects were instructed to record any adverse event occurring after vaccination in the Patient Diary Card. For the immunogenicity assessment, an antibody titer test was performed prior to dosing at Visit 2 (baseline) and 28 days (Visit 4) after the first vaccination for both the test group and comparator group.
The investigator evaluated the safety and immunogenicity for each subject throughout the study. Safety assessments were performed 28 days after the first dose (Visit 4, End-of-Study Visit) for the comparator group receiving a single-dose regimen of Fluarix Prefilled Syringe, and for the test group receiving a two-dose regimen of the test drug, 28 days after the first dose (Visit 4) and 28 days after the second dose (Visit 6, End-of-Study Visit). Subjects were instructed to record any adverse event occurring after vaccination in the Patient Diary Card. For the immunogenicity assessment, an antibody titer test was performed prior to dosing at Visit 2 (baseline) and 28 days (Visit 4) after the first vaccination for both the test group and comparator group.
Study Oversight
Has Oversight DMC:
False
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?: