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
  Purpose

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.


Condition Intervention Phase
Influenza
Biological: Step 1
Biological: Step 2
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Green Cross Corporation:

Primary Outcome Measures:
  • 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 ]

Enrollment: 346
Study Start Date: February 2010
Study Completion Date: December 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MG1109 - Step 1 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
Placebo Comparator: Normal Saline - Step 1 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
Experimental: MG1109 - Step 2 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

Detailed Description:

MG1109 is purified, inactivated influenza viral antigen.

  Eligibility

Ages Eligible for Study:   18 Years to 58 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01389466

Locations
Korea, Republic of
Korea University Ansan Hospital
Ansan, Korea, Republic of
Inha University Hospital
Inchon, Korea, Republic of
Korea University Guro Hospital
Seoul, Korea, Republic of
Catholic University Of Korea ST. Vincent's Hospital
Suwon, Korea, Republic of
Sponsors and Collaborators
Green Cross Corporation
Investigators
Principal Investigator: Woo Joo Kim, MD, Ph.D Korea University Guro Hospital
  More Information

No publications provided

Responsible Party: Green Cross Corporation
ClinicalTrials.gov Identifier: NCT01389466     History of Changes
Other Study ID Numbers: MG1109_P1/2
Study First Received: June 19, 2011
Last Updated: June 24, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Green Cross Corporation:
Avian influenza

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
Respiratory Tract Diseases
Respiratory Tract Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 23, 2014