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

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ClinicalTrials.gov Identifier: NCT01389466
Recruitment Status : Completed
First Posted : July 8, 2011
Last Update Posted : November 21, 2014
Sponsor:
Collaborator:
Korean Center for Disease Control and Prevention
Information provided by (Responsible Party):
Green Cross Corporation

Brief Summary:
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 or disease Intervention/treatment Phase
Influenza Biological: Step 1 Biological: Step 2 Phase 1 Phase 2

Detailed Description:
MG1109 is purified, inactivated influenza viral antigen.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 346 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : February 2010
Actual Primary Completion Date : November 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Percentage of subjects achieving post-vaccination Hemagglutination Inhibition(HI) antibody titer ≥ 1:40 in each dose group [ Time Frame: 42 days after vaccination ]
  2. Number of subjects with Solicited / Unsolicited adverse events [ Time Frame: With in 24 weeks after vaccination ]


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Ages Eligible for Study:   18 Years to 58 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Korean Center for Disease Control and Prevention
Investigators
Principal Investigator: Woo Joo Kim, MD, Ph.D Korea University Guro Hospital

Responsible Party: Green Cross Corporation
ClinicalTrials.gov Identifier: NCT01389466     History of Changes
Other Study ID Numbers: MG1109_P1/2
First Posted: July 8, 2011    Key Record Dates
Last Update Posted: November 21, 2014
Last Verified: November 2014

Keywords provided by Green Cross Corporation:
Avian influenza

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