To Evaluate the Effectiveness(Immunogenicity) and Safety of 'GC3102C' Administered Intramuscularly in Healthy Adults

A Phase III, Randomized, Double-blind, Multi-center Study to Compare the Immunological Efficacy and Safety of GC3102C With GC FLU Inj. Administered Intramuscularly in Healthy Adults

The primary objective is to demonstrate the immunological non-inferiority between GC3102C and GC FLU inj. influenza vaccines by assessing geometric mean titers(GMTs) in healthy adults

Study Overview

• Status: Completed
• Conditions: Prophylaxis Against Influenza
• Intervention / Treatment: Biological: GC FLU inj.; Biological: GC3102C

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy adults, 18 to <60 years old
• Subjets willing to provide written informed consent and able to comply with the requirements for the study

Exclusion Criteria:

• Subjects with a history of hypersensitivity, especially anaphylactic reactions to egg, egg proteins, chicken or components of vaccine such as gentamicin, gelatin, and arginine
• Subjects with a history of Guillain-Barré syndrome
• Subjects with severe chronic diseases (e.g., cardiovascular diseases without controllable hypertension, hemoglobinopathy, respiratory, metabolic, and renal disorders) who are considered by the investigator to be ineligible for the study
• Subjects previously treated with anti-coagulant therapy or hemophiliac patients who may be at risk of severe hemorrhage after an intramuscular injection
• Subjects who have had an acute febrile (at least 38.0°C) episode at some time during the 72 hours before enrollment
• Subjects who have received a vaccination within 7 days before enrollment or who are scheduled for another vaccination (excluding the study vaccine) during the study
• Immunocompromised subjects with immunodeficiency diseases or those who are receiving immunosuppressive or immunomodulatory therapy, e.g., azathioprine, cyclosporin, interferon, granulocyte-colony stimulating factor, tacrolimus, everolimus, sirolimus
• Subjects who have received high-dose corticosteroids in the 3 months before vaccination or who will be administered a cumulative dose of 700 mg of corticosteroids during the study. Inhaled, intranasal, and local application of corticosteroids is permitted, regardless of dosage, and corticosteroids such as prednisolone at a maximum dose of 15 mg/day are allowed
• Subjects who have been administered immunoglobulins or blood-derived products 3 months before enrollment or who are scheduled for the administration during the study
• Subjects who have received an influenza vaccine within 6 months of enrollment
• A female subject who is pregnant or who is breast-feeding. Subjects of childbearing potential without an appropriate contraceptive measure within 30 days before enrollment and who do not agree to use a clinically acceptable method of birth control during the study (e.g., oral contraceptives, condom, diaphragm or intrauterine device, or vasectomy of male partner)
• Subjects who have participated in any other clinical trials within 30 days of the administration of the study vaccine
• Individuals with other clinically significant medical or psychological condition who are considered by the investigator to be ineligible for the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: GC FLU inj.; Influneza vaccine, single-dose vial	Biological: GC FLU inj.; a single dose (0.5 mL) intramuscularly on the deltoid muscle
EXPERIMENTAL: GC3102C; Influneza vaccine, multi-dose vial	Biological: GC3102C; a single dose (0.5 mL) intramuscularly on the deltoid muscle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
GMT, using the Hemagglutination inhibition(HI) antibody titer	Day 21

Secondary Outcome Measures

Outcome Measure	Time Frame
Rate of subjects achieving seroconversion	Day 0 , Day 21
Rate of subjects achieving seroprotection	Day 21
Number of Participants Reporting a Solicited Adverse Events After Vaccination	Day 6
Number of Participants Reporting a Unsolicited Adverse Events After Vaccination	Day 21

Collaborators and Investigators

• Sponsor: Green Cross Corporation

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (ACTUAL): July 1, 2013
• Study Completion (ACTUAL): July 1, 2013

Study Registration Dates

• First Submitted: December 12, 2012
• First Submitted That Met QC Criteria: December 13, 2012
• First Posted (ESTIMATE): December 17, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): January 15, 2016
• Last Update Submitted That Met QC Criteria: January 14, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: GC3102C_P3