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

NCT ID: NCT02658409

Last Updated: 2016-02-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 1630 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30

Brief Summary

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

Detailed 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.

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

GC3106(quadrivalent)

0.5ml, intramuscular, a single dosing

Group Type: EXPERIMENTAL

GC3106(quadrivalent cell-culture based influenza vaccine)

Intervention Type: BIOLOGICAL

GC3106(quadrivalent),0.5ml, intramuscular, a single dosing at Day 1

Fluarix™tetra Syringe Inj.(Quadrivalent)

0.5ml,intramuscular,a single dosing

Group Type: ACTIVE_COMPARATOR

Fluarix™tetra Syringe Inj.(quadrivalent influenza vaccine)

Intervention Type: BIOLOGICAL

Fluarix™tetra Syringe Inj., 0.5ml, intramuscular, a single dosing at Day 1

Interventions

GC3106(quadrivalent cell-culture based influenza vaccine)

GC3106(quadrivalent),0.5ml, intramuscular, a single dosing at Day 1

Intervention Type: BIOLOGICAL

Fluarix™tetra Syringe Inj.(quadrivalent influenza vaccine)

Fluarix™tetra Syringe Inj., 0.5ml, intramuscular, a single dosing at Day 1

Intervention Type: BIOLOGICAL

Other Intervention Names

GC3106; Fluarix™tetra Syringe Inj.

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Green Cross Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lee Jin Su, M.D

Role: STUDY_DIRECTOR

Inha University Hospital

Choi Won Seck, M.D

Role: STUDY_DIRECTOR

Korea University Ansan Hospital

Lee Ja Cob

Role: STUDY_DIRECTOR

Hallym Univ. Medical Center

Woo Heong Jung

Role: STUDY_DIRECTOR

Hallym Univ. Medical Center

Wi Sung Heon

Role: STUDY_DIRECTOR

St Vincent's Hospital

Jeong Suk In

Role: STUDY_DIRECTOR

Chonnam Natinal University Hospital

Kim Sin Woo

Role: STUDY_DIRECTOR

Kyungpook National University Hospital

Kim Tae Hyung

Role: STUDY_DIRECTOR

Soon Chun Hyang Univ. Hospital

Locations

Korea University Guro Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

GC3106_AD_P3

Identifier Type: -

Identifier Source: org_study_id