The purpose of this study is to describe the immunogenicity and safety of the cell culture-derived influenza vaccine compared with the egg-derived influenza vaccine among subjects. To describe the immunogenicity, antibody levels are evaluated by hemagglutination inhibition(HI) assay from sera obtained pre-vaccination and 21 days post-vaccination. To describe the safety, the time of onset and duration of local and systemic solicited adverse events are assessed and reported. Unsolicited adverse events and serious adverse events are collected and categorized throughout the study period.
This is a multi-center, randomized, double-blind study in healthy adult and elderly subjects. Subjects receive a single dose of one of the influenza vaccine formulations and provide blood samples for immunogenicity assessment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,155
0.5 mL, intramuscular, a single dose
0.5 mL, intramuscular, a single dose
Geometric Mean Titers (GMTs) for Each of the Influenza Vaccine Antigen
* Percentage of Participants With Seroprotection to Each of the Influenza Vaccine Antigen Post-Vaccination. * Percentage of Participants Achieving Seroconversion at Day 21 Post-Vaccination With Influenza Vaccine. * Pre- and Post- Vaccination Geometric Mean Ratio (GMR)
Time frame: Day 0 and Day 21 post-vaccination
Immunogenicity in subjects with a pre-vaccination HI antibody titer <1:80
Time frame: Day 0 and Day 21 post-vaccination
Immunogenicity compared to control group
Time frame: Day 21 post vaccination, 6 months post vaccination
Long-term Immunogenicity
Time frame: 6 months post-vaccination
Percentage of participants with Solicited Local Adverse Event (AE)
Time frame: During 7 days post-vaccination
Percentage of participants with Solicited Systemic Adverse Event (AE)
Time frame: During 7 days post-vaccination
Percentage of participants with Unsolicited Adverse Event (AE)
Time frame: During 21 days post-vaccination
Percentage of participants with Severe Adverse Event (SAE)
Time frame: During 6 months post-vaccination
Vital Sign
Body Temperature, Blood Pressure(SBP/DBP), Pulse
Time frame: Day 0 and Day 21 post vaccination
Physical Examination
inspection, palpation (feel), percussion (tap to determine resonance characteristics), and auscultation (listen)
Time frame: Day 0 and Day 21 post vaccination
Clinical Laboratory Tests
Blood test(CBC, Coagulation, Chemistry), Urinalysis
Time frame: Day 0 and Day 21 post vaccination
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