Safety, Tolerability, and Immunogenicity of GC3106 (Quadrivalent Cell-culture Based Influenza Vaccine)

Phase 1

Completed

• Conditions: Influenza
• Interventions: Biological: Trivalent influenza vaccine; Biological: Quadrivalent cell-culture based influenza vaccin

• Registration Number: NCT02249221
• Lead Sponsor: Green Cross Corporation

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of GC3106 after single intramuscular administration in Korean healthy adults.

Detailed Description

This study is the first in human trial of GC3106 and is designed as an adaptive Phase I/IIa to ensure participants protection. Part A is an open-label and single arm study in 9 healthy volunteers. Data and Safety Monitoring Board (DSMB) will review the solicited/unsolicited adverse events conditionally if any toxicity of Grade 3 or 4 has been reported during 7 days after vaccination from the first 9 healthy volunteers. Part B is a randomized (2:1), double-blind, active controlled study and a total of 75 volunteers will participate in this part. Adverse events assessment will be done according to the 'Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials'.

Study Timeline

• Study First Submitted: 2014-09-23
• Study First Submitted QC: 2014-09-23
• Study First Posted: 2014-09-25
• Study Start: 2014-10
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-04
• Last Update Posted: 2014-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• Given written informed consent
• Healthy Korean adults (age: between over 19 and under 65)
• Korean adults who agree with 21 days follow up after vaccination and good compliance to study procedures
• Those who are able to comply with the requirements for the study

Exclusion Criteria

• Inability in written/verbal communication
• Subjects who have participated in other interventional study within 30 days
• Alcohol or drug abuse within 6 months
• Heavy drinkers or subjects who do not agree to stop drinking for 3 days before vaccination and other 3 days after vaccination
• Who got the treatment of psychotropic drugs and narcotic analgesic drugs within 6 months of enrollment
• Hypersensitivity with drug or active ingredient
• Disorders in immune function
• History of Guillain-Barré syndrome
• Disease/medications which are likely to cause any severe bleeding
• Active infection or experience of fever (>38.0 ℃) within 72 hours following vaccination
• Oral temperature >38.0 ℃ at the vaccination day
• Erythema, tattoo, injury at shoulder (vaccination site)
• Influenza vaccination within 6months
• Any vaccination within 30 days
• Concomitant medications/therapy such as immunosuppressants or immune modifying drugs, systemic corticosteroids, immunoglobulins, blood or blood- derived products, or anti-cancer chemotherapy or radiation therapy within3 months
• Pregnant or breast-feeding women
• Clinically significant underlying diseases or medical history at investigator's discretion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Trivalent influenza vaccine	Trivalent influenza vaccine	Day 1: GC Flu Pre-filled Syringe Inj., 0.5ml, intramuscular, a single dosing
Quadrivalent cell-culture based influenza vaccin	Quadrivalent cell-culture based influenza vaccin	Day 1: GC3106, 0.5ml, intramuscular, a single dosing

Primary Outcome Measures

Name	Time	Method
Solicited adverse events following vaccination	Day 1 up to 7 Days post vaccination	Solicited injection site reactions: Pain, Tenderness, Erythema, Redness, Induration, and Swelling; Solicited systemic reactions: Fever, Sweating, Chill, Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, arthralgia.
Unsolicited adverse events following vaccination	Day 1 up to 22 Days post vaccination	It can be estimated by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials
Abnormalities in physical examination, vital signs, and/or clinical laboratory tests	Day 22 post vaccination

Secondary Outcome Measures

Name	Time	Method
Seroprotection rate of HI (Hemagglutination Inhibition) antibody for each strain	Day 22 post vaccination
Seroconversion rate of HI (Hemagglutination Inhibition) antibody for each strain	Day 22 post vaccination
GMT(geometric mean titers) for each strain	Day 22 post vaccination

Trial Locations

Locations (1)

Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of