A Study to Evaluate the Safety and Efficacy(Immunogenicity) of GC3114 in Healthy Adults

Green Cross Corporation

Status and phase

Completed

Phase 1

Conditions

Influenza, Human

Treatments

Biological: GCFLU Quadrivalent

Biological: GC3114

Study type

Interventional

Funder types

Industry

Identifiers

NCT03357263

GC3114_P1

Details and patient eligibility

About

Healthy adults will be once administered GC3114A(High-dose Quadrivalent influenza vaccine) or GCFLU Quadrivalent Pre-filled syringe inj..

Full 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.

Enrollment

40 patients

Sex

All

Ages

19 to 64 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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 criteria

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