A Multicenter, Double-blind, Parallel, Non-inferiority, Phase III Study

Green Cross Corporation

Status and phase

Unknown

Phase 3

Conditions

Influenza

Treatments

Biological: Fluarix™tetra Syringe Inj.(quadrivalent influenza vaccine)

Biological: GC3106(quadrivalent cell-culture based influenza vaccine)

Study type

Interventional

Funder types

Industry

Identifiers

NCT02658409

GC3106_AD_P3

Details and patient eligibility

About

A Multicenter, Randomized, Double-blind, Active-controlled, Parallel, Non-inferiority, Phase III Study.

Full description

A Multicenter, Randomized, Double-blind, Active-controlled, Parallel, Non-inferiority, Phase III Study to Investigate the Efficacy (Immunogenicity) and Safety of GC3106 (quadrivalent cell-culture based influenza vaccine) after Intramuscular Administration in Healthy Subjects.

Enrollment

1,630 patients

Sex

All

Ages

19+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Given written informed consent
Healthy Korean adults (age: between over 19)
Women of childbearing age with negative Urine hCG in screening visit

Exclusion criteria

Subjects unable to communicate (illiterate or who cannot understand the questionnaire and/or the study subject diary)
Subjects participating in another clinical study or has participated in a clinical study in the last 30 days (the participation should be based on the final dose of the investigational drug)
Subjects with impaired immune functions that include immune deficiency diseases
Subjects with a history of Guillain-Barre syndrome
Hemophilia patients at risk of serious bleeding with intramuscular injection or who had taken an anticoagulant
Subjects with symptoms of active infection or who had higher than 38.0℃ fever before the investigational product administration
Subjects to be planned to have a surgery in the study duration or subject who the investigator decides exception because of a clinical significant chronic or malignant disease or medical history to interrupt the study procedure
Subjects with erythema and/or a tattoo in the injection site of the scheduled investigational product (the deltoid muscle) that is hard to identify the topical toxicity
Subjects with a history of allergic reaction to eggs or chicken, the vaccine components, and/or Formaldehyed, Gentamicin and Sodium Deoxychloate
Subjects who had been administered the influenza vaccine 6 months before the scheduled vaccination of the investigational product
Subjects who had been vaccinated with another vaccine within 30 days before the investigational product administration or had a scheduled vaccination during the clinical study period
Subjects who had received an immunosuppressant, immunity-modifying drug, cytotoxic chemotherapy that can affect his or her immune system, or radiation therapy within 3 months before the investigational product administration
Subjects receiving systemic steroids (more than 20 mg/day of prednisolone administered everyday over 14 days or more than 700 mg of a cumulative dose during the same period of time) within 3 months before the administration (Day 1) of the investigational product (topical ointments, eye drops, inhalants or intranasally/intramuscularly administered drugs, or topically applied drugs such as ligaments; unless administered every other day over 14 days)
Subjects who had received immunoglobulin or a blood-derived product within 3 months before being vaccinated with the investigational product or is scheduled to receive those products during the clinical study period
Pregnant women, nursing mothers, or women of childbearing age who do not perform adequate contraception (using a condom, diaphragm, IUD, or hormonal contraception 21 days before vaccination with the investigational product or whose male partner had undergone a vasectomy)

Subjects who have other clinically significant medical or psychiatric examination findings deemed by the investigator to make them ineligible for participation in this clinical study