Status:
COMPLETED
A Study to Evaluate the Safety and Efficacy(Immunogenicity) of GC3114 in Healthy Adults
Lead Sponsor:
Green Cross Corporation
Conditions:
Influenza, Human
Eligibility:
All Genders
19-64 years
Phase:
PHASE1
Brief Summary
Healthy adults will be once administered GC3114A(High-dose Quadrivalent influenza vaccine) or GCFLU Quadrivalent Pre-filled syringe inj..
Detailed Description
Healthy adults will be once administered GC3114A(High-dose Quadrivalent influenza vaccine) or GCFLU Quadrivalent Pre-filled syringe inj.. Safety and immunological efficacy will be evaluated.
Eligibility Criteria
Inclusion
- Healthy adults aged 19-64 years old
- Informed consent form has been signed and dated
- Able to comply with the requirements of the study
Exclusion
- 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
Key Trial Info
Start Date :
November 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 22 2017
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03357263
Start Date
November 20 2017
End Date
December 22 2017
Last Update
November 19 2018
Active Locations (1)
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1
Korea University Guro Hospital
Seoul, South Korea