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

Study Overview
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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.

Official Title
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Randomized, Double Blind, Multicenter, Phase III Study to Evaluate the Immunogenicity and Safety of 'MG1109(Egg-based, Pre-pandemic Influenza(H5N1) Vaccine)' Administered Intramuscularly in Healthy Adult Volunteers

Conditions
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Influenza

Intervention / Treatment
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* Biological: MG1109
* Biological: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MG1109<br>MG1109 0.5 mL Intramuscularly injection, twice at an interval of 21 days | Biological: MG1109<br> <br> |
| Placebo Comparator: Placebo<br>Placebo(for MG1109) 0.5 mL Intramuscularly injection, twice at an interval of 21 days | Biological: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects achieving post-vaccination Hemagglutination Inhibition(HI) antibody titer ≥ 1:40 |  | 1st vaccination   21 days after 2nd vaccination | 
| Percentage of subjects achieving post-vaccination seroconversion for Hemagglutination Inhibition(HI) antibody |  | 1st vaccination   21 days after 2nd vaccination | 
| GMR(Geometric Mean Ratio) of Hemagglutination Inhibition(HI) antibody titer at post-vaccination compared to pre-vaccination |  | 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 |  | 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 |  | 1st vaccination   24 weeks after 2nd vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GMT(Geometric Mean Titer) of Hemagglutination Inhibition(HI) antibody titer pre-vaccination and post-vaccination |  | 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 |  | 1st vaccination   21 days after 2nd vaccination | 
| Vital signs(body temperature, pulse) |  | 1st vaccination   21 days after 2nd vaccination | 
| The results of physical examinations |  | 1st vaccination   21 days after 2nd vaccination | 
| Lab results(Hematology, Blood chemistry, Urinalysis) |  | 1st vaccination   21 days after 2nd vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Avian influenza