A Study to Evaluate the Efficacy and Safety of GC3110A in Healthy Subjects Aged 65 Years and Older

Green Cross Corporation

Status and phase: Completed; Phase 3

Conditions: Influenza, Human

Treatments: Biological: GC3110A vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02917304

GC3110A_ED_P3

Details and patient eligibility

About

The purpose of this study is to evaluate immunological efficacy and safety of GC3110A among healthy adults over 65 years of age.

Full description

Adults over 65 years of age will be once administered GC3110A(Quadrivalent influenza vaccine).

Enrollment: 274 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy adults aged 65 years and older
• Informed consent form has been signed and dated
• Able to comply with the requirements of the study

Exclusion criteria

• Known systemic hypersensitivity 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: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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274 participants in 1 patient group

GC3110A vaccine group

Experimental group

Description:

Participants administered a single dose of GC3110A(Quadrivalent Influenza Vaccine).

Treatment:

Biological: GC3110A vaccine