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

Primary Purpose

Influenza

Status

Completed

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Step 1

Step 2

About this trial

This is an interventional prevention trial for Influenza focused on measuring Avian influenza

Eligibility Criteria

18 Years - 58 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Korea University Ansan Hospital
Inha University Hospital
Korea University Guro Hospital
Catholic University Of Korea ST. Vincent's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

MG1109 - Step 1

Normal Saline - Step 1

MG1109 - Step 2

Arm Description

Outcomes

Primary Outcome Measures

Percentage of subjects achieving post-vaccination Hemagglutination Inhibition(HI) antibody titer ≥ 1:40 in each dose group

Number of subjects with Solicited / Unsolicited adverse events

Secondary Outcome Measures

Full Information

NCT ID

NCT01389466

First Posted

June 19, 2011

Last Updated

November 20, 2014

Sponsor

Green Cross Corporation

Collaborators

Korean Center for Disease Control and Prevention

1. Study Identification

Unique Protocol Identification Number

NCT01389466

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Completed

Study Start Date

February 2010 (undefined)

Primary Completion Date

November 2011 (Actual)

Study Completion Date

December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Green Cross Corporation

Collaborators

Korean Center for Disease Control and Prevention

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

MG1109 is purified, inactivated influenza viral antigen.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza

Keywords

Avian influenza

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

346 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MG1109 - Step 1

Arm Type

Experimental

Arm Title

Normal Saline - Step 1

Arm Type

Placebo Comparator

Arm Title

MG1109 - Step 2

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

Step 1

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Step 2

Intervention Description

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 Measure Information:

Title

Percentage of subjects achieving post-vaccination Hemagglutination Inhibition(HI) antibody titer ≥ 1:40 in each dose group

Time Frame

42 days after vaccination

Title

Number of subjects with Solicited / Unsolicited adverse events

Time Frame

With in 24 weeks after vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

58 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Woo Joo Kim, MD, Ph.D

Organizational Affiliation

Korea University Guro Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Korea University Ansan Hospital

City

Ansan

Country

Korea, Republic of

Facility Name

Inha University Hospital

City

Inchon

Country

Korea, Republic of

Facility Name

Korea University Guro Hospital

City

Seoul

Country

Korea, Republic of

Facility Name

Catholic University Of Korea ST. Vincent's Hospital

City

Suwon

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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