A Phase I/IIa Study of GC3110A (Quadrivalent Influenza Vaccine)

A Randomized, 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 GC3110A (Quadrivalent Influenza Vaccine)

The purpose of this study is to determine whether GC3110A (a QIV) is effective compared to GC Flu Pre-filled Syringe Inj. (a marketed TIV) after single intramuscular administration in Korean healthy adults.

The comparator, GC Flu pre-filled syringe inj. is a trivalent influenza vaccine (TIV) including viruses representing 3 influenza strains (one A/HIN1, one A/H3N2, and one B). However, two antigenically distinct lineages of influenza B (Victoria and Yamagata) co-circulate annually in the United States. Predicting which lineage of influenza B will predominate during a season is challenging, and cross-protection by immunization against the other lineage is expected to be low. One proposed alternative is to produce a quadrivalent influenza vaccine (QIV) including an influenza B virus from each of the two circulating lineages. GC3110A is a new quadrivalent influenza vaccine (QIV), which contains all of 4 vaccine components WHO recommends for use in the 2013-14 influenza season (northern hemisphere winter) and includes two influenza B viruses. GC3110A is expected to show the additional public health benefit compared with traditional TIV.

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: Quadrivalent influenza vaccine; Biological: Trivalent influenza vaccine

Detailed Description

This study is the first in human trial of GC3110A 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. 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 (Actual): 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: No
• 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)
• Hypersensitivity with egg, chicken, or any of the vaccine components, or Neomycin, Gentamicin
• 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

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Quadrivalent influenza vaccine(Part A); Day 1: GC3110A, 0.5ml, intramuscular, a single dosing	Biological: Quadrivalent influenza vaccine; GC3110A, 0.5ml, intramuscular, a single dosing at Day 1; Other Names: GC3110A
Experimental: Quadrivalent influenza vaccine(Part B); Day 1: GC3110A, 0.5ml, intramuscular, a single dosing	Biological: Quadrivalent influenza vaccine; GC3110A, 0.5ml, intramuscular, a single dosing at Day 1; Other Names: GC3110A
Active Comparator: Trivalent influenza vaccine(Part B); 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
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

Secondary Outcome Measures

Outcome Measure	Time Frame
Abnormalities in physical examination, vital signs, and/or clinical laboratory tests	Day 22 post vaccination
GMT(geometric mean titers) for each strain	Day 22 post vaccination

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: April 22, 2014
• First Submitted That Met QC Criteria: April 23, 2014
• First Posted (Estimate): April 24, 2014

Study Record Updates

• Last Update Posted (Estimate): August 13, 2014
• Last Update Submitted That Met QC Criteria: August 12, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: Influenza vaccine; Vaccination; QIV; Quadrivalent 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: GC3110A_P1/2a