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

November 20, 2014 updated by: Green Cross Corporation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

MG1109 is purified, inactivated influenza viral antigen.

Study Type

Interventional

Enrollment (Actual)

346

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Ansan, Korea, Republic of
        • Korea University Ansan Hospital
      • Inchon, Korea, Republic of
        • Inha University Hospital
      • Seoul, Korea, Republic of
        • Korea University Guro Hospital
      • Suwon, Korea, Republic of
        • Catholic University of Korea St. Vincent's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Green Cross Corporation

Collaborators

Korean Center for Disease Control and Prevention

Investigators

  • Principal Investigator: Woo Joo Kim, MD, Ph.D, Korea University Guro Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

June 19, 2011

First Submitted That Met QC Criteria

July 7, 2011

First Posted (Estimate)

July 8, 2011

Study Record Updates

Last Update Posted (Estimate)

November 21, 2014

Last Update Submitted That Met QC Criteria

November 20, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MG1109_P1/2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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