Study to Evaluate the Safety and Immunogenicity of MG1109 in Healthy Adult Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Green Cross Corporation
ClinicalTrials.gov Identifier:
NCT01389466
First received: June 19, 2011
Last updated: June 24, 2013
Last verified: June 2013

June 19, 2011
June 24, 2013
February 2010
November 2011   (final data collection date for primary outcome measure)
  • Percentage of subjects achieving post-vaccination Hemagglutination Inhibition(HI) antibody titer ≥ 1:40 in each dose group [ Time Frame: 42 days after vaccination ] [ Designated as safety issue: No ]
  • Number of subjects with Solicited / Unsolicited adverse events [ Time Frame: With in 24 weeks after vaccination ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01389466 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Study to Evaluate the Safety and Immunogenicity of MG1109 in Healthy Adult Volunteers
Randomized Phase I/II Study to Evaluate the Safety and Immunogenicity of 'MG1109(Egg-based, Pre-pandemic Influenza(H5N1) Vaccine)' Administered Intramuscularly in Healthy Adult Volunteers

This study was designed in two steps with Step 1, a single-center, double-blind, randomized clinical Pilot study and Step 2, a multi-center, single-blind, randomized clinical Pivotal study. The investigator evaluate the immunogenicity and safety of the investigational vaccine in the subjects during their participation in the study.

MG1109 is purified, inactivated influenza viral antigen.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Influenza
  • Biological: Step 1
    Investigational Product : MG1109 Dose : Cohort 1 : 0.125 mL Cohort 2 :0.25 mL Cohort 3 :0.5 mL Cohort 4 :1.0 mL intramuscularly injection, twice at an interval of 21 days
  • Biological: Step 2
    Investigational Product : MG1109 Dose : Cohort 1 :0.5 mL Cohort 2 :1.0 mL intramuscularly injection, twice at an interval of 21 days
  • Experimental: MG1109 - Step 1
    Intervention: Biological: Step 1
  • Placebo Comparator: Normal Saline - Step 1
    Intervention: Biological: Step 1
  • Experimental: MG1109 - Step 2
    Intervention: Biological: Step 2
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
346
December 2011
November 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy adults who are available for follow-up during the study

Exclusion Criteria:

  • Subjects with history of exposure to the H5N1 subtype or H5N1 subtype vaccine
  • Subjects with immune system disorder including immune deficiency disease
Both
18 Years to 58 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01389466
MG1109_P1/2
No
Green Cross Corporation
Green Cross Corporation
Not Provided
Principal Investigator: Woo Joo Kim, MD, Ph.D Korea University Guro Hospital
Green Cross Corporation
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP