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Completed

NCT Number: NCT02352584

A Multicenter, Double-blind, Parallel Phase III Study

A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Phase III

Completed

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Korea University Guro Hospital

Seoul, South Korea

About this study

A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Phase III Study to Investigate the Efficacy(Immunogenicity) and Safety of GC3110A(Quadrivalent Influenza Vaccine) After Intramuscular Administration in Healthy Subjects

Who can participate

Healthy volunteers accepted: Yes

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

Criteria: Inclusion Criteria:

  • Given written informed consent
  • Healthy Korean adults (age: over 19 )
  • 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
  • Who got the treatment of psychotropic drugs and narcotic analgesic drugs within 6 months of enrollment
  • 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

Treatment and study plan

GC3110A(Quadrivalent)

Biological

GC3110A(Quadrivalent), 0.5ml, intramuscular, a single dosing at Day 1

Other names: GC3110A

GC Flu(Trivalent)

Biological

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

Other names: GC Flu Pre-filled Syringe Inj.

GC3110A(Trivalent)

Biological

GC3110A(Trivalent), 0.5ml, intramuscular, a single dosing at Day 1

Other names: GC3110A

Primary outcomes

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

    Time frame: Day 21 post vaccination

    GMT (Active comparator) / GMT(Experimental)

  2. Solicited adverse events following vaccination

    Time frame: Day0 up to 21 Day 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

  3. Unsolicited adverse events following vaccination

    Time frame: Day0 up to 21 Day post vaccination

    It can be estimated by Toxicity Grading Scale for healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials

  4. SCR rate of HI(Hemagglutination Inhibition) antibody for each strain

    Time frame: Day 21 post vaccination

    Difference of SCR (Experimental and Active comparator)

Secondary outcomes

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

    Time frame: Day0 up to 21 Day post vaccination

  2. SPR rate of HI(Hemagglutination Inhibition) antibody

    Time frame: Day 21 post vaccination

  3. GMT rate of HI(Hemagglutination Inhibition) antibody for each strain

    Time frame: Day 21 post vaccination

  4. Abnormalities in physical examination, Vital signs, clinical laboratory tests

    Time frame: Day 21 post vaccination

  5. SAE

    Time frame: Day 180 post vaccination

Sponsors and collaborators

Lead sponsor

Green Cross Corporation

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Phase III Study to Investigate the Efficacy(Immunogenicity) and Safety of GC3110A(Quadrivalent Influenza Vaccine)

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Feb 2, 2015
Registry last updated
Oct 20, 2015

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.

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