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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Green Cross Corporation
ClinicalTrials.gov Identifier:
NCT01750814
First received: December 12, 2012
Last updated: July 8, 2013
Last verified: July 2013
  Purpose

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


Condition Intervention Phase
Prophylaxis Against Influenza
Biological: GC3102C
Biological: GC FLU inj.
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official 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

Resource links provided by NLM:


Further study details as provided by Green Cross Corporation:

Primary Outcome Measures:
  • GMT, using the Hemagglutination inhibition(HI) antibody titer [ Time Frame: Day 21 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Rate of subjects achieving seroconversion [ Time Frame: Day 0 , Day 21 ] [ Designated as safety issue: No ]
  • Rate of subjects achieving seroprotection [ Time Frame: Day 21 ] [ Designated as safety issue: No ]
  • Number of Participants Reporting a Solicited Adverse Events After Vaccination [ Time Frame: Day 6 ] [ Designated as safety issue: Yes ]
  • Number of Participants Reporting a Unsolicited Adverse Events After Vaccination [ Time Frame: Day 21 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: June 2013
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: GC FLU inj. Biological: GC FLU inj.
Experimental: GC3102C Biological: GC3102C

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Green Cross Corporation
ClinicalTrials.gov Identifier: NCT01750814     History of Changes
Other Study ID Numbers: GC3102C_P3
Study First Received: December 12, 2012
Last Updated: July 8, 2013
Health Authority: Vietnam: Ministry of Health

ClinicalTrials.gov processed this record on October 21, 2014