Ignite Creation Date:
2024-05-06 @ 2:47 AM
Last Modification Date:
2024-10-26 @ 11:23 AM
Study NCT ID:
NCT02121782
Status:
COMPLETED
Last Update Posted:
2014-08-13
First Post:
2014-04-22
Brief Title:
A Phase IIIa Study of GC3110A Quadrivalent Influenza Vaccine
Sponsor:
Green Cross Corporation
Organization:
GC Biopharma Corp
Study Overview
Official Title:
A Randomized Open-label Part A or Double-blind Part B Active-controlled Part B Phase IIIa Study to Investigate the Safety Tolerability and Immunogenicity of GC3110A Quadrivalent Influenza Vaccine
Status:
COMPLETED
Status Verified Date:
2014-08
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:
The purpose of this study is to determine whether GC3110A a QIV is effective compared to GC Flu Pre-filled Syringe Inj a marketed TIV after single intramuscular administration in Korean healthy adults
The comparator GC Flu pre-filled syringe inj is a trivalent influenza vaccine TIV including viruses representing 3 influenza strains one AHIN1 one AH3N2 and one B However two antigenically distinct lineages of influenza B Victoria and Yamagata co-circulate annually in the United States Predicting which lineage of influenza B will predominate during a season is challenging and cross-protection by immunization against the other lineage is expected to be low One proposed alternative is to produce a quadrivalent influenza vaccine QIV including an influenza B virus from each of the two circulating lineages GC3110A is a new quadrivalent influenza vaccine QIV which contains all of 4 vaccine components WHO recommends for use in the 2013-14 influenza season northern hemisphere winter and includes two influenza B viruses GC3110A is expected to show the additional public health benefit compared with traditional TIV
The comparator GC Flu pre-filled syringe inj is a trivalent influenza vaccine TIV including viruses representing 3 influenza strains one AHIN1 one AH3N2 and one B However two antigenically distinct lineages of influenza B Victoria and Yamagata co-circulate annually in the United States Predicting which lineage of influenza B will predominate during a season is challenging and cross-protection by immunization against the other lineage is expected to be low One proposed alternative is to produce a quadrivalent influenza vaccine QIV including an influenza B virus from each of the two circulating lineages GC3110A is a new quadrivalent influenza vaccine QIV which contains all of 4 vaccine components WHO recommends for use in the 2013-14 influenza season northern hemisphere winter and includes two influenza B viruses GC3110A is expected to show the additional public health benefit compared with traditional TIV
Detailed Description:
This study is the first in human trial of GC3110A 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 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