The aim of this study is to assess the immunogenicity and safety of a quadrivalent influenza vaccine compared with a trivalent influenza vaccine in participants aged above 3 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
2,688
0.5 mL, intramuscular, one dose
0.5 mL, intramuscular, one dose
0.5 mL, intramuscular, one dose
Suining County Center for Disease Control and Prevention
Xuzhou, Jiangsu, China
Xinyi County Center for Disease Control and Prevention
Xuzhou, Jiangsu, China
Number of participants that presented seroconversion post injection
* Seroconvertion is defined as: prevaccination Hemagglutination-inhibition test (HI) antibody titer ≤1:10 and postvaccination HI antibody titer ≥1:40, or prevaccination HI antibody titer ≥1:10 and a postvaccination increase by a factor of four or more. * Participants will be collected blood post first study injection, when blood samples will be taken for HI testing
Time frame: 30 days after inoculation
Geometric mean of Hemagglutination-inhibition titre post first study injection
* Geometric mean of Hemagglutination-inhibition test titre will be calculated for the different groups of participants post first study injection. * Participants will be collected blood post first study injection, when blood samples will be taken for HI testing.
Time frame: 30 days after inoculation
Number of participants that presented seroprotection post injection
* Seroprotection is defined as postvaccination Hemagglutination-inhibition test (HI) antibody titer ≥ 1:40. * Participants will be collected blood post first study injection, when blood samples will be taken for HI testing
Time frame: 30 days after inoculation
Number of Subjects Reporting Solicited and Unsolicited Adverse Events (AEs)
* For each group the incidence rate of subjects with solicited AE(s) with 95% confidence interval * For each group the incidence rate of subjects with unsolicited AE(s) with 95% confidence interval
Time frame: Continuous observation for 30 days after two inoculations
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