Skip to main content
OpenTrials
Completed

NCT Number: NCT02249221

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Korea University Guro Hospital

Seoul, South Korea

About this study

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'.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quadrivalent cell-culture based influenza vaccin

Biological

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

Other names: GC3106

Trivalent Influenza Vaccine

Biological

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

Other names: GC Flu Pre-filled Syringe Inj.

Primary outcomes

  1. Solicited adverse events following vaccination

    Time frame: 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.

  2. Unsolicited adverse events following vaccination

    Time frame: 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

  3. Abnormalities in physical examination, vital signs, and/or clinical laboratory tests

    Time frame: Day 22 post vaccination

Secondary outcomes

  1. Seroprotection rate of HI (Hemagglutination Inhibition) antibody for each strain

    Time frame: Day 22 post vaccination

  2. Seroconversion rate of HI (Hemagglutination Inhibition) antibody for each strain

    Time frame: Day 22 post vaccination

  3. GMT(geometric mean titers) for each strain

    Time frame: Day 22 post vaccination

Sponsors and collaborators

Lead sponsor

Green Cross Corporation

Industry

Registry information

Official study title

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)

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Sep 25, 2014
Registry last updated
Dec 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.