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

NCT ID: NCT02249221

Last Updated: 2014-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2014-11-30

Brief Summary

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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

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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'.

Conditions

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Influenza

Keywords

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Influenza vaccine Vaccination cell-culture based influenza vaccine cell culture derived influenza vaccine CCIV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Quadrivalent cell-culture based influenza vaccin

Day 1: GC3106, 0.5ml, intramuscular, a single dosing

Group Type EXPERIMENTAL

Quadrivalent cell-culture based influenza vaccin

Intervention Type BIOLOGICAL

GC3106, 0.5ml, intramuscular, a single dosing at Day 1

Trivalent influenza vaccine

Day 1: GC Flu Pre-filled Syringe Inj., 0.5ml, intramuscular, a single dosing

Group Type ACTIVE_COMPARATOR

Trivalent influenza vaccine

Intervention Type BIOLOGICAL

GC Flu Pre-filled Syringe Inj., 0.5ml, intramuscular, a single dosing at Day 1

Interventions

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Quadrivalent cell-culture based influenza vaccin

GC3106, 0.5ml, intramuscular, a single dosing at Day 1

Intervention Type BIOLOGICAL

Trivalent influenza vaccine

GC Flu Pre-filled Syringe Inj., 0.5ml, intramuscular, a single dosing at Day 1

Intervention Type BIOLOGICAL

Other Intervention Names

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GC3106 GC Flu Pre-filled Syringe Inj.

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Green Cross Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Woo Joo KIM, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Korea University Guro Hospital

Chang-Hee LEE, M.D.

Role: STUDY_DIRECTOR

Green Cross Corporation

Locations

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Korea University Guro Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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GC3106_P1/2a

Identifier Type: -

Identifier Source: org_study_id