A Study to Evaluate the Safety and Efficacy(Immunogenicity) of GC3114 in Healthy Adults
Randomized, Single-Blind, Active Comparator-controlled Study to Evaluate the Safety and Immunological Efficacy of GC3114 in Healthy Adults.
1 other identifier
interventional
40
1 country
1
Brief Summary
Healthy adults 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_1
Started Nov 2017
Shorter than P25 for phase_1
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
Study Start
First participant enrolled
November 20, 2017
CompletedFirst Submitted
Initial submission to the registry
November 24, 2017
CompletedFirst Posted
Study publicly available on registry
November 29, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 22, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 22, 2017
CompletedNovember 19, 2018
November 1, 2018
1 month
November 24, 2017
November 15, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Adverse Event
Solicited/Unsolicited Adverse Event
for 7 days from Day0/during study period
Secondary Outcomes (3)
Percentage of participants achieving pre-defined Seroconversion Before and following vaccination
Day 0 and Day 21
Percentage of participants achieving pre-defined Seroprotection Before and following vaccination
Day 0 and Day 21
Geometric Mean Titer and Geometric Mean Titer Ratios of Antibodies to the Investigational Product Before and Following vaccination
Day 0 and Day 21
Study Arms (2)
GC3114
EXPERIMENTALPre-filled syringe inj., 0.5ml, Once, IM
GCFLU Quadrivalent
ACTIVE COMPARATORPre-filled syringe inj., 0.5ml, Once, IM
Interventions
Eligibility Criteria
You may qualify if:
- Healthy adults aged 19-64 years old
- Informed consent form has been signed and dated
- Able to comply with the requirements of the study
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
- Pregnant or lactating women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Korea University Guro Hospital
Seoul, South Korea
Related Publications (1)
Noh JY, Jang YS, Lee SN, Choi MJ, Yoon JG, Yu DH, Song JY, Cheong HJ, Kim WJ. Randomized, single-blind, active-controlled phase I clinical trial to evaluate the immunogenicity and safety of GC3114 (high-dose, quadrivalent influenza vaccine) in healthy adults. Vaccine. 2019 Aug 23;37(36):5171-5176. doi: 10.1016/j.vaccine.2019.07.076. Epub 2019 Jul 31.
PMID: 31377075DERIVED
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 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 24, 2017
First Posted
November 29, 2017
Study Start
November 20, 2017
Primary Completion
December 22, 2017
Study Completion
December 22, 2017
Last Updated
November 19, 2018
Record last verified: 2018-11
Data Sharing
- IPD Sharing
- Will not share