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

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)

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

Study Overview

• Status: Unknown
• Conditions: Influenza
• Intervention / Treatment: Biological: GC3106(quadrivalent cell-culture based influenza vaccine); Biological: Fluarix™tetra Syringe Inj.(quadrivalent influenza vaccine)

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 Type: Interventional
• Enrollment (Actual): 1630
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Korea University Guro Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Fluarix™tetra Syringe Inj.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Green Cross Corporation
• Investigators: Study Director: Lee Jin Su, M.D, Inha University Hospital; Study Director: Choi Won Seck, M.D, Korea University Ansan Hospital; 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; 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

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: December 6, 2015
• First Submitted That Met QC Criteria: January 15, 2016
• First Posted (Estimate): January 18, 2016

Study Record Updates

• Last Update Posted (Estimate): February 26, 2016
• Last Update Submitted That Met QC Criteria: February 25, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Influenza vaccine; Vaccination; CCIV; quadrivalent cell-culture based influenza vaccine
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: GC3106_AD_P3