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

NCT ID: NCT01987011

Last Updated: 2015-07-03

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

PHASE3

Total Enrollment

420 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-03-31

Brief Summary

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The purpose of this study is to 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

DOUBLE

Participants Investigators

Study Groups

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MG1109

MG1109 0.5 mL Intramuscularly injection, twice at an interval of 21 days

Group Type EXPERIMENTAL

MG1109

Intervention Type BIOLOGICAL

Placebo

Placebo(for MG1109) 0.5 mL Intramuscularly injection, twice at an interval of 21 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Interventions

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MG1109

Intervention Type BIOLOGICAL

Placebo

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

60 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_P3

Identifier Type: -

Identifier Source: org_study_id

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