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

A Randomized (Part B), Open-label (Part A) or Double-blind (Part B), Active-controlled (Part B) Phase I/IIa Study to Investigate the Safety, Tolerability, and Immunogenicity of GC3106 (Quadrivalent Cell-culture Based Influenza Vaccine)

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

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: Trivalent influenza vaccine; Biological: Quadrivalent cell-culture based influenza vaccin

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 Type: Interventional
• Enrollment (Anticipated): 84
• Phase: Phase 2; Phase 1

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 to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Quadrivalent cell-culture based influenza vaccin; Day 1: GC3106, 0.5ml, intramuscular, a single dosing	Biological: Quadrivalent cell-culture based influenza vaccin; GC3106, 0.5ml, intramuscular, a single dosing at Day 1; Other Names: GC3106
Active Comparator: Trivalent influenza vaccine; Day 1: GC Flu Pre-filled Syringe Inj., 0.5ml, intramuscular, a single dosing	Biological: Trivalent influenza vaccine; GC Flu Pre-filled Syringe Inj., 0.5ml, intramuscular, a single dosing at Day 1; Other Names: GC Flu Pre-filled Syringe Inj.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Solicited adverse events following 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.	Day 1 up to 7 Days post vaccination
Unsolicited adverse events following vaccination	It can be estimated by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials	Day 1 up to 22 Days post vaccination
Abnormalities in physical examination, vital signs, and/or clinical laboratory tests		Day 22 post vaccination

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Green Cross Corporation
• Investigators: Study Director: Chang-Hee LEE, M.D., Green Cross Corporation; Principal Investigator: Woo Joo KIM, M.D., Ph.D, Korea University Guro Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: September 23, 2014
• First Submitted That Met QC Criteria: September 23, 2014
• First Posted (Estimate): September 25, 2014

Study Record Updates

• Last Update Posted (Estimate): December 5, 2014
• Last Update Submitted That Met QC Criteria: December 4, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Influenza vaccine; Vaccination; CCIV; cell-culture based influenza vaccine; cell culture derived influenza vaccine
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: GC3106_P1/2a