Skip to main content
OpenTrials
Completed

NCT Number: NCT01750814

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: Yes

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

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

  • 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

Treatment and study plan

GC3102C

Biological

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

GC FLU inj.

Biological

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

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

Sponsors and collaborators

Lead sponsor

Green Cross Corporation

Industry

Registry information

Official study title

A Phase III, Randomized, Double-blind, Multi-center Study to Compare the Immunological Efficacy and Safety of GC3102C With GC FLU Inj. Administered Intramuscularly in Healthy Adults

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Dec 17, 2012
Registry last updated
Jan 15, 2016

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.