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

Green Cross Corporation346 enrolled

Overview

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.

MG1109 is purified, inactivated influenza viral antigen.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

346

Conditions

Influenza

Interventions

Step 1BIOLOGICAL

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

Step 2BIOLOGICAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 58 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 in each dose group

Time frame: 42 days after vaccination

Number of subjects with Solicited / Unsolicited adverse events

Time frame: With in 24 weeks after vaccination

Data from ClinicalTrials.gov

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