This study is a randomized, double-blind phase Ⅳ clinical trial of quadrivalent influenza vaccine (Split Virion), inactivated manufactured by Sinovac Biotech Co., Ltd.The purpose of this study is to evaluate the lot-to-lot consistency, immunogenicity and safety of quadrivalent influenza vaccine (Split Virion), inactivated in health subjects aged 9-59 years old.
This study is a randomized, double-blind phase Ⅳ clinical trial in health subjects aged 9-59 years old to evaluate the lot-to-lot consistency,immunogenicity and safety of quadrivalent influenza vaccine (Split Virion), inactivated.The experimental vaccine was manufactured by Sinovac Biotech Co., Ltd.A total of 1260 subjects,including 360 subjects aged 9-17 years and 900 subjects aged 18-59 years will be enrolled.The subjects in each age group will be randomly divided into three groups in a ratio of 1:1:1 to receive one dose of three lots of quadrivalent influenza vaccine (Split Virion), inactivated produced on a commercial scale,respectively.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
1,260
The Quadrivalent Influenza Vaccine manufactured by Sinovac Biotech Co.,Ltd. The four influenza strains(including 4 antigens H1N1, H3N2, BV and BY, 15μg for each) in 0.5 mL of sodium chloride,disodium hydrogen phosphate,sodium dihydrogen phosphate water for per injection.The routine of administration is intramuscular injection into deltoid region.And the immunization schedule is one dose of quadrivalent influenza vaccine on day 0.
Yuping Dong Autonomous County Center for Disease Control and Prevention
Zhumadian, Guizhou, China
Immunogenicity index of GMT
GMT of HI antibodies of each influenza strain at 28 days after vaccination.
Time frame: 28 days after vaccination
Immunogenicity index of seroconversion rate
Seroconversion rate of HI antibodies of each influenza strain at 28 days after vaccination.
Time frame: 28 days after vaccination
Immunogenicity index of protection rate
Protection rate of HI antibodies of each influenza strain at 28 days after vaccination (HI antibody titer ≥1:40).
Time frame: 28 days after vaccination
Immunogenicity index of GMI
GMI of HI antibodies of each influenza strain at 28 days after vaccination.
Time frame: 28 days after vaccination
Safety index of the incidence of adverse reactions
Incidence of adverse reactions from 0 to 28 days after vaccination.
Time frame: From 0 to 28 days after vaccination.
Safety index -The incidence of adverse reactions
Incidence of adverse reactions from 0 to 7 days after vaccination.
Time frame: From 0 to 7 days after vaccination.
Safety index of the incidence of serious adverse events
Incidence of serious adverse events from 0 to 28 days after vaccination.
Time frame: From 0 to 28 days after vaccination
Safety index of incidence of adverse events
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Incidence of adverse events of special concern from 0 to 28 days after vaccination.
Time frame: From 0 to 28 days after vaccination