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

NCT ID: NCT01389466

Last Updated: 2014-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

346 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2011-12-31

Brief Summary

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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

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MG1109 is purified, inactivated influenza viral antigen.

Conditions

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Influenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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MG1109 - Step 1

Group Type EXPERIMENTAL

Step 1

Intervention Type BIOLOGICAL

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

Normal Saline - Step 1

Group Type PLACEBO_COMPARATOR

Step 1

Intervention Type BIOLOGICAL

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

MG1109 - Step 2

Group Type EXPERIMENTAL

Step 2

Intervention Type BIOLOGICAL

Investigational Product : MG1109 Dose : Cohort 1 :0.5 mL Cohort 2 :1.0 mL intramuscularly injection, twice at an interval of 21 days

Interventions

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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

Intervention Type 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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

58 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Korean Center for Disease Control and Prevention

OTHER_GOV

Sponsor Role collaborator

Green Cross Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Woo Joo Kim, MD, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Korea University Guro Hospital

Locations

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Korea University Ansan Hospital

Ansan, , South Korea

Site Status

Inha University Hospital

Inchon, , South Korea

Site Status

Korea University Guro Hospital

Seoul, , South Korea

Site Status

Catholic University Of Korea ST. Vincent's Hospital

Suwon, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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MG1109_P1/2

Identifier Type: -

Identifier Source: org_study_id