A Study to Evaluate the Safety and Efficacy(Immunogenicity) of GC3114 in Elderly Healthy Subjects
Open-labeled(Part 1), Single-group(Part 2), Randomized(Part 2), Double-blind(Part 2), Active-controlled(Part 2) Pharse II Clinical Trial to Evaluate Safety and Efficacy(Immunogenicity) of GC3114 in Elderly Healthy Subjects
1 other identifier
interventional
105
1 country
1
Brief Summary
Elderly healthy subjects will be once administered GC3114A(High-dose Quadrivalent influenza vaccine) or GCFLU Quadrivalent Pre-filled syringe inj..
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2018
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 27, 2018
CompletedFirst Posted
Study publicly available on registry
September 5, 2018
CompletedStudy Start
First participant enrolled
October 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 13, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 13, 2018
CompletedJanuary 4, 2019
January 1, 2019
2 months
August 27, 2018
January 3, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Adverse Event
Solicited/Unsolicited Adverse Event
for 7 days from Day0/during study period
Secondary Outcomes (4)
Percentage of participants achieving pre-defined Seroconversion Before and following vaccination
Day 0 and Day 28
Percentage of participants achieving pre-defined Seroprotection Before and following vaccination
Day 0 and Day 28
Geometric Mean Titer of Antibodies to the Investigational Product Before and Following vaccination
Day 0 and Day 28
Geometric Mean Ratio of Antibodies to the Investigational Product Before and Following vaccination
Day 0 and Day 28
Study Arms (2)
GC3114
EXPERIMENTALPre-filled syringe inj., 0.5ml, Once, IM
Active Comparator: GCFLU Quadrivalent
ACTIVE COMPARATORPre-filled syringe inj., 0.5ml, Once, IM
Interventions
Eligibility Criteria
You may qualify if:
- Healthy adults aged over 65 years old
- Informed consent form has been signed and dated
You may not qualify if:
- Known systemic hypersensitive to eggs, chicken proteins, or any of the vaccine components
- Personal history of Guillain-Barre syndrome(GBS)
- Subjects with severe chronic disease who are considered by investigator to be ineligible for the study
- Subjects who received a vaccination within 28 days before enrollment or who are scheduled for another vaccination during the study
- Immunocompromised subjects with immunodeficiency disease or subjects receiving immunosuppressive or immunomodulating therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Korea University Guro Hospital
Seoul, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Woo Joo KIm, M.D, Ph.D
Korea University Guro Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Part 1 : Open label, Part 2 : Double blind
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 27, 2018
First Posted
September 5, 2018
Study Start
October 1, 2018
Primary Completion
December 13, 2018
Study Completion
December 13, 2018
Last Updated
January 4, 2019
Record last verified: 2019-01