NCT02249221

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2014

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 25, 2014

Completed
6 days until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

December 5, 2014

Status Verified

December 1, 2014

Enrollment Period

1 month

First QC Date

September 23, 2014

Last Update Submit

December 4, 2014

Conditions

Influenza

Keywords

Influenza vaccineVaccinationcell-culture based influenza vaccinecell culture derived influenza vaccineCCIV

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • 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

Study Arms (2)

Quadrivalent cell-culture based influenza vaccin

EXPERIMENTAL

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

Biological: Quadrivalent cell-culture based influenza vaccin

Trivalent influenza vaccine

ACTIVE COMPARATOR

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

Biological: Trivalent influenza vaccine

Interventions

Quadrivalent cell-culture based influenza vaccinBIOLOGICAL

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

Also known as: GC3106
Quadrivalent cell-culture based influenza vaccin
Trivalent influenza vaccineBIOLOGICAL

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

Also known as: GC Flu Pre-filled Syringe Inj.
Trivalent influenza vaccine

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korea University Guro Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Woo Joo KIM, M.D., Ph.D

    Korea University Guro Hospital

    PRINCIPAL INVESTIGATOR

  • Chang-Hee LEE, M.D.

    Green Cross Corporation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2014

First Posted

September 25, 2014

Study Start

October 1, 2014

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

December 5, 2014

Record last verified: 2014-12

Locations

KR(1)