CClinicalTrials.gg
CompletedNCT01750814Updated Jan 15, 2016

To Evaluate the Effectiveness(Immunogenicity) and Safety of 'GC3102C' Administered Intramuscularly in Healthy Adults

A Phase 3 interventional study of GC3102C and GC FLU inj. in Prophylaxis Against Influenza, sponsored by Green Cross Corporation. Completed. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-01-15.

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

Phase
Phase 3
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

The primary objective is to demonstrate the immunological non-inferiority between GC3102C and GC FLU inj. influenza vaccines by assessing geometric mean titers(GMTs) in healthy adults

02

Conditions studied

  • Prophylaxis Against Influenza
03

In context

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
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy adults, 18 to \<60 years old
  • Subjets willing to provide written informed consent and able to comply with the requirements for the study

Exclusion criteria

Exclusion Criteria:

  • Subjects with a history of hypersensitivity, especially anaphylactic reactions to egg, egg proteins, chicken or components of vaccine such as gentamicin, gelatin, and arginine
  • Subjects with a history of Guillain-Barré syndrome
  • Subjects with severe chronic diseases (e.g., cardiovascular diseases without controllable hypertension, hemoglobinopathy, respiratory, metabolic, and renal disorders) who are considered by the investigator to be ineligible for the study
  • Subjects previously treated with anti-coagulant therapy or hemophiliac patients who may be at risk of severe hemorrhage after an intramuscular injection
  • Subjects who have had an acute febrile (at least 38.0°C) episode at some time during the 72 hours before enrollment
  • Subjects who have received a vaccination within 7 days before enrollment or who are scheduled for another vaccination (excluding the study vaccine) during the study
  • Immunocompromised subjects with immunodeficiency diseases or those who are receiving immunosuppressive or immunomodulatory therapy, e.g., azathioprine, cyclosporin, interferon, granulocyte-colony stimulating factor, tacrolimus, everolimus, sirolimus
  • Subjects who have received high-dose corticosteroids in the 3 months before vaccination or who will be administered a cumulative dose of 700 mg of corticosteroids during the study. Inhaled, intranasal, and local application of corticosteroids is permitted, regardless of dosage, and corticosteroids such as prednisolone at a maximum dose of 15 mg/day are allowed
  • Subjects who have been administered immunoglobulins or blood-derived products 3 months before enrollment or who are scheduled for the administration during the study
  • Subjects who have received an influenza vaccine within 6 months of enrollment
  • A female subject who is pregnant or who is breast-feeding. Subjects of childbearing potential without an appropriate contraceptive measure within 30 days before enrollment and who do not agree to use a clinically acceptable method of birth control during the study (e.g., oral contraceptives, condom, diaphragm or intrauterine device, or vasectomy of male partner)
  • Subjects who have participated in any other clinical trials within 30 days of the administration of the study vaccine
  • Individuals with other clinically significant medical or psychological condition who are considered by the investigator to be ineligible for the study
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
400 participants (actual)

Study arms

  • Active comparator
    GC FLU inj.

    Influneza vaccine, single-dose vial

    Biological: GC FLU inj.

  • Experimental
    GC3102C

    Influneza vaccine, multi-dose vial

    Biological: GC3102C

Interventions

  • BiologicalGC3102C

    a single dose (0.5 mL) intramuscularly on the deltoid muscle

  • BiologicalGC FLU inj.

    a single dose (0.5 mL) intramuscularly on the deltoid muscle

06

What researchers measure

Primary outcomes

  1. GMT, using the Hemagglutination inhibition(HI) antibody titer

    Time frame: Day 21

Secondary outcomes

  1. Rate of subjects achieving seroconversion

    Time frame: Day 0 , Day 21

  2. Rate of subjects achieving seroprotection

    Time frame: Day 21

  3. Number of Participants Reporting a Solicited Adverse Events After Vaccination

    Time frame: Day 6

  4. Number of Participants Reporting a Unsolicited Adverse Events After Vaccination

    Time frame: Day 21

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 15, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01750814
Lead sponsor
Green Cross Corporation
Responsible party
Sponsor
First posted
Dec 17, 2012
Start date
Jun 2013
Primary completion
Jul 2013
Completion
Jul 2013
Last update
Jan 15, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

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