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

Phase 3CompletedNCT01987011

Green Cross Corporation420 enrolled

Overview

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.

MG1109 is purified, inactivated influenza viral antigen.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

420

Conditions

Influenza

Interventions

MG1109BIOLOGICAL

PlaceboBIOLOGICAL

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (4)

Korea University Ansan Hospital

Ansan, South Korea

Inha University Hospital

Inchon, South Korea

Korea University Guro Hospital

Seoul, South Korea

Catholic University Of Korea ST. Vincent's Hospital

Suwon, South Korea

Outcomes

Primary Outcomes

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

Time frame: 1st vaccination ~ 21 days after 2nd vaccination

Percentage of subjects achieving post-vaccination seroconversion for Hemagglutination Inhibition(HI) antibody

Time frame: 1st vaccination ~ 21 days after 2nd vaccination

GMR(Geometric Mean Ratio) of Hemagglutination Inhibition(HI) antibody titer at post-vaccination compared to pre-vaccination

Time frame: 1st vaccination ~ 21 days after 2nd vaccination

The percentage of subjects reporting solicited adverse events from the date of vaccination until 7 days after each vaccination

Time frame: Each vaccination ~ 7 days after each vaccination

The percentage of subjects reporting unsolicited adverse events from the date of 1st vaccination until 24weeks after 2nd vaccination

Time frame: 1st vaccination ~ 24 weeks after 2nd vaccination

Secondary Outcomes

GMT(Geometric Mean Titer) of Hemagglutination Inhibition(HI) antibody titer pre-vaccination and post-vaccination

Time frame: 1st vaccination ~ 21 days after 2nd vaccination

GMT(Geometric Mean Titer) and GMR(Geometric Mean Ratio) of neutralizing antibody titer pre-vaccination and post-vaccination

Time frame: 1st vaccination ~ 21 days after 2nd vaccination

Vital signs(body temperature, pulse)

Time frame: 1st vaccination ~ 21 days after 2nd vaccination

The results of physical examinations

Data from ClinicalTrials.gov

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