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

Green Cross Corporation

Status and phase: Completed; Phase 2

Conditions: Influenza, Human

Treatments: Biological: GCFLU Quadrivalent; Biological: GC3114

Study type: Interventional

Funder types: Industry

Identifiers

NCT03657719

GC3114_P2

Details and patient eligibility

About

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

Full description

Elderly healthy subjects 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: 105 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy adults aged over 65 years old
• Informed consent form has been signed and dated

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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105 participants in 2 patient groups

GC3114

Experimental group

Description:

Pre-filled syringe inj., 0.5ml, Once, IM

Treatment:

Biological: GC3114

Active Comparator: GCFLU Quadrivalent

Active Comparator group

Description:

Pre-filled syringe inj., 0.5ml, Once, IM

Treatment:

Biological: GCFLU Quadrivalent