A Multicenter, Double-blind, Parallel Phase III Study

Green Cross Corporation

Status and phase: Completed; Phase 3

Conditions: Influenza

Treatments: Biological: GC Flu(Trivalent); Biological: GC3110A(Quadrivalent); Biological: GC3110A(Trivalent)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02352584

GC3110A_AD_P3

Details and patient eligibility

About

A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Phase III

Full description

A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Phase III Study to Investigate the Efficacy(Immunogenicity) and Safety of GC3110A(Quadrivalent Influenza Vaccine) After Intramuscular Administration in Healthy Subjects

Enrollment: 1,299 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Criteria: Inclusion Criteria:

• Given written informed consent
• Healthy Korean adults (age: over 19 )
• Korean adults who agree with 21 days follow up after vaccination and good compliance to study procedures
• Those who are able to comply with the requirements for the study

Exclusion Criteria:

• Inability in written/verbal communication
• Subjects who have participated in other interventional study within 30 days
• Alcohol or drug abuse within 6 months
• Who got the treatment of psychotropic drugs and narcotic analgesic drugs within 6 months of enrollment
• Disorders in immune function
• History of Guillain-Barré syndrome
• Disease/medications which are likely to cause any severe bleeding
• Active infection or experience of fever (>38.0 ℃) within 72 hours following vaccination
• Oral temperature >38.0 ℃ at the vaccination day
• Erythema, tattoo, injury at shoulder (vaccination site)
• Hypersensitivity with egg, chicken, or any of the vaccine components, or Neomycin, Gentamicin
• Influenza vaccination within 6months
• Any vaccination within 30 days
• Concomitant medications/therapy such as immunosuppressants or immune modifying drugs, systemic corticosteroids, immunoglobulins, blood or blood- derived products, or anti-cancer chemotherapy or radiation therapy within3 months
• Pregnant or breast-feeding women
• Clinically significant underlying diseases or medical history at investigator's discretion

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,299 participants in 3 patient groups

GC3110A(Quadrivalent)

Experimental group

Description:

0.5ml, intramuscular, a single dosing

Treatment:

Biological: GC3110A(Quadrivalent)

GC Flu (Trivalent)

Active Comparator group

Description:

0.5ml,intramuscular,a single dosing

Treatment:

Biological: GC Flu(Trivalent)

GC3110A(Trivalent)

Active Comparator group

Description:

0.5ml,intramuscular,a single dosing

Treatment:

Biological: GC3110A(Trivalent)