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
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Green Cross Corporation
- Enrollment
- 420
- Locations
- 4
- Primary Endpoint
- Percentage of subjects achieving post-vaccination seroconversion for Hemagglutination Inhibition(HI) antibody
Study Overview
Brief Summary
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
MG1109 is purified, inactivated influenza viral antigen.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
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 unsolicited adverse events from the date of 1st vaccination until 24weeks after 2nd vaccination
Time Frame: 1st vaccination ~ 24 weeks after 2nd vaccination
Percentage of subjects achieving post-vaccination Hemagglutination Inhibition(HI) antibody titer ≥ 1:40
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
Secondary Outcomes
- Lab results(Hematology, Blood chemistry, Urinalysis)(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)
- 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)