This is a randomized, double-blind, active-controlled Phase I clinical trial to evaluate the safety and immunogenicity of Influenza Vaccine (Split Virion), Inactivated (High Dose) developed by Sinovac.
50 participants aged 60 years and older will be enrolled and randomly assigned in a 1:1 ratio to receive one dose of the investigational vaccine or the active control vaccine (Anflu®).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
50
A single 0.5 mL dose of the investigational high-dose split influenza virus vaccine will be administered by intramuscular (IM) injection into the deltoid muscle of the upper arm. Each dose contains 60 μg of hemagglutinin from each influenza virus strain used for the current influenza season.
A single 0.5 mL dose of the active control standard-dose split influenza virus vaccine will be administered by intramuscular (IM) injection into the deltoid muscle of the upper arm. Each dose contains 15 μg of hemagglutinin from each influenza virus strain used for the current influenza season.
Urad Middle Banner Center for Disease Control and Prevention
Bayan Nur, Inner Mongolia, China
Incidence of Adverse Reactions
Time frame: Day 0 to Day 28 after vaccination
Incidence of adverse reactions
Time frame: Day 0 to Day 7
Incidence of serious adverse events
Time frame: within 6 months after vaccination
Seropositive Rate of HI Antibodies
Time frame: Day 14
Seroprotection Rate of HI Antibodies
Time frame: Day 14
GMT of HI Antibodies
Time frame: Day 14
GMI of HI Antibodies
Time frame: Day 14
Seropositive Rate of HI Antibodies
Time frame: Day 28
Seroprotection Rate of HI Antibodies
Time frame: Day 28
GMT of HI Antibodies
Time frame: Day 28
GMI of HI Antibodies
Time frame: Day 28
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