Phase III study to evaluate the immunogenicity and safety of 'MG1109' in healthy adult volunteers
Not Applicable
Completed
- Conditions
- Diseases of th respiratory system
- Registration Number
- KCT0001027
- Lead Sponsor
- Korea Centers for Disease Control and Prevention
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 420
Inclusion Criteria
Healthy adults who are available for follow-up during the study
Exclusion Criteria
1. Subjects with history of exposure to the H5N1 subtype or H5N1 subtype vaccine
2. Subjects with immune system disorder including immune deficiency disease
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of subjects achieving post-vaccination Hemagglutination Inhibition(HI) antibody titer = 1:40;Percentage of subjects achieving post-vaccination seroconversion for Hemagglutination Inhibition(HI) antibody;GMR(Geometric Mean Ratio) of Hemagglutination Inhibition(HI) antibody titer at post-vaccination compared to pre-vaccination;The percentage of subjects reporting solicited adverse events from the date of vaccination to 7 days after each vaccination;The percentage of subjects reporting unsolicited adverse events from the date of 1st vaccination to 24weeks after 2nd vaccination
- Secondary Outcome Measures
Name Time Method Vital signs(body temperature, pulse);GMT(Geometric Mean Titer) of Hemagglutination Inhibition(HI) antibody titer pre-vaccination and post-vaccination;GMT(Geometric Mean Titer) and GMR(Geometric Mean Ratio) of neutralizing antibody titer pre-vaccination and post-vaccination;The results of physical examinations;Lab results(Hematology, Blood chemistry, Urinalysis)