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

• ClinicalTrials.gov Identifier: NCT02658409
• Recruitment Status: Unknown
• First Posted: January 18, 2016
• Last Update Posted: February 26, 2016
• Sponsor: Green Cross Corporation
• Information provided by (Responsible Party): Green Cross Corporation

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Influenza	Biological: GC3106(quadrivalent cell-culture based influenza vaccine); Biological: Fluarix™tetra Syringe Inj.(quadrivalent influenza vaccine)	Phase 3

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1630 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Prevention
• Official Title: 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)
• Study Start Date: November 2015
• Actual Primary Completion Date: November 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: GC3106(quadrivalent); 0.5ml, intramuscular, a single dosing	Biological: GC3106(quadrivalent cell-culture based influenza vaccine); GC3106(quadrivalent),0.5ml, intramuscular, a single dosing at Day 1; Other Name: GC3106
Active Comparator: Fluarix™tetra Syringe Inj.(Quadrivalent); 0.5ml,intramuscular,a single dosing	Biological: Fluarix™tetra Syringe Inj.(quadrivalent influenza vaccine); Fluarix™tetra Syringe Inj., 0.5ml, intramuscular, a single dosing at Day 1; Other Name: Fluarix™tetra Syringe Inj.

Outcome Measures

Primary Outcome Measures :

1. The effect of the vaccination after 21 days of hemagglutination inhibition antibody (HI antibody) titer was measured through the GMT ratio [ Time Frame: Day 21 post vaccination ]
   (GMT control drug/ GMT test drug)
2. The effect of the vaccination after 21 days of hemagglutination inhibition antibody (HI antibody) titer was measured through the difference between the SCRs [ Time Frame: Day 21 post vaccination ]
   (SCR control drug- SPR test drug)
3. Solicited adverse events: Day 0~Day 6 [ Time Frame: Day 0~Day 6 ]
4. Unsolicited adverse events: Day 0~Day 21 [ Time Frame: Day 0~Day 21 ]

Secondary Outcome Measures :

1. Rate of subjects achieving seroconversion, defined as post vaccination HI antibody titers [ Time Frame: 21 days after vaccination ]
2. Rate of subjects achieving seroprotection, defined as post vaccination HI antibody titers [ Time Frame: 21 days after vaccination ]
3. Vital sign and physical examination [ Time Frame: For 180 days after Visit 1 ]
4. For 180 days after Visit 1, serious adverse events were presented with the results. [ Time Frame: For 180 days after Visit 1 ]

Eligibility Criteria

• Ages Eligible for Study: 19 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

Korea, Republic of

Korea University Guro Hospital

Seoul, Korea, Republic of

Sponsors and Collaborators

Green Cross Corporation

Investigators

• Study Director: Lee Jin Su, M.D; Inha University Hospital
• Study Director: Choi Won Seck, M.D; Korea University
• Study Director: Lee Ja Cob; Hallym Univ. Medical Center
• Study Director: Woo Heong Jung; Hallym Univ. Medical Center
• Study Director: Wi Sung Heon; St. Vincent's Hospital-Manhattan
• Study Director: Jeong Suk In; Chonnam Natinal University Hospital
• Study Director: Kim Sin Woo; Kyungpook National University Hospital
• Study Director: Kim Tae Hyung; Soon Chun Hyang Univ. Hospital

More Information

• Responsible Party: Green Cross Corporation
• ClinicalTrials.gov Identifier: NCT02658409
• Other Study ID Numbers: GC3106_AD_P3
• First Posted: January 18, 2016
• Last Update Posted: February 26, 2016
• Last Verified: January 2016

Keywords provided by Green Cross Corporation:

CCIV; quadrivalent cell-culture based influenza vaccine; Influenza vaccine; Vaccination

Additional relevant MeSH terms:

Influenza, Human; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Vaccines; Immunologic Factors; Physiological Effects of Drugs