A Study to Evaluate Efficacy and Safety of GC3110B in Healthy Adults

Green Cross Corporation

Status and phase

Unknown

Phase 3

Conditions

Influenza, Human

Treatments

Biological: GCFLU Quadrivalent Inj. vaccine

Biological: GC3110B vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT02915809

GC3110B_P3

Details and patient eligibility

About

The purpose of this study is to evaluate immunological efficacy and safety of GC3110B versus GCFLU Quadrivalent Inj. among healthy adults in 18 to 60 years of age.

Full description

Adults 18 to 60 years of age will be randomly assigned in a 1:1 ratio to receive either GC3110B or GCFLU Quadrivalent Inj.

Enrollment

414 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy adults aged 18 to 60 years
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-Barré syndrome
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