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CompletedNCT02352584Updated Oct 20, 2015

A Multicenter, Double-blind, Parallel Phase III Study

A Phase 3 interventional study of GC3110A(Quadrivalent) and GC Flu(Trivalent) in Influenza, sponsored by Green Cross Corporation. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-10-20.

Sponsored by Green Cross Corporation · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
1,299
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study summary

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

Read the detailed description

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

02

Conditions studied

  • Influenza

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Keywords

  • QIV
  • Quadrivalent Influenza Vaccine
  • Influenza vaccine
  • Vaccination
03

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.

This study's planned enrollment of 1,299 is above the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

Green Cross Corporation is the lead sponsor of 61 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
1,299 participants (estimated)

Study arms

  • Experimental
    GC3110A(Quadrivalent)

    0.5ml, intramuscular, a single dosing

    Biological: GC3110A(Quadrivalent)

  • Active comparator
    GC Flu (Trivalent)

    0.5ml,intramuscular,a single dosing

    Biological: GC Flu(Trivalent)

  • Active comparator
    GC3110A(Trivalent)

    0.5ml,intramuscular,a single dosing

    Biological: GC3110A(Trivalent)

Interventions

  • BiologicalGC3110A(Quadrivalent)

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

    Also known as: GC3110A

  • BiologicalGC Flu(Trivalent)

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

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

  • BiologicalGC3110A(Trivalent)

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

    Also known as: GC3110A

06

What researchers measure

Primary outcomes

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

    GMT (Active comparator) / GMT(Experimental)

    Time frame: Day 21 post vaccination

  2. 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

    Time frame: Day0 up to 21 Day post vaccination

  3. 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

    Time frame: Day0 up to 21 Day post vaccination

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

    Difference of SCR (Experimental and Active comparator)

    Time frame: Day 21 post vaccination

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

07

Study locations

1 site
  • Korea University Guro Hospital
    Seoul, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 20, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02352584
Lead sponsor
Green Cross Corporation
Responsible party
Sponsor
First posted
Feb 2, 2015
Start date
Oct 2014
Primary completion
Dec 2014
Completion
Jul 2015
Last update
Oct 20, 2015

Study contacts

Lee Jin Su, M.D
study director · Inha University Hospital
Choi Won Seck, M.D
study director · Korea University Ansan Hospital
Lee Ja Cob
study director · Hallym Univ. Medical Center
Woo Heong Jung
study director · Hallym Univ. Medical Center
Wi Sung Heon
study director · St Vincent's Hospital
Jeong Suk In
study director · Chonnam Natinal University Hospital
Kim Sin Woo
study director · Kyungpook National University Hospital
Kim Tae Hyung
study director · Soon Chun Hyang Univ. Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

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