Phase III Study to Evaluate the Immunogenicity and Safety of MG1109 in Healthy Adult Volunteers
Phase 3
Completed
- Conditions
- Influenza
- Registration Number
- NCT01987011
- Lead Sponsor
- Green Cross Corporation
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 420
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 unsolicited adverse events from the date of 1st vaccination until 24weeks after 2nd vaccination 1st vaccination ~ 24 weeks after 2nd vaccination Percentage of subjects achieving post-vaccination Hemagglutination Inhibition(HI) antibody titer ≥ 1:40 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 Percentage of subjects achieving post-vaccination seroconversion for Hemagglutination Inhibition(HI) antibody 1st vaccination ~ 21 days after 2nd vaccination
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (4)
Korea University Ansan Hospital
🇰🇷Ansan, Korea, Republic of
Inha University Hospital
🇰🇷Inchon, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Catholic University Of Korea ST. Vincent's Hospital
🇰🇷Suwon, Korea, Republic of
Korea University Ansan Hospital🇰🇷Ansan, Korea, Republic of