To evaluate the safety and immunogenicity of quadrivalent influenza virus split vaccine in healthy population aged 3-8 years following different immunization procedures.
To evaluate the safety and immunogenicity of quadrivalent influenza virus split vaccine in healthy population aged 3-8 years following different immunization procedures, and the participants randomized to receive two injections of 0.5 mL quadrivalent influenza vaccine at day 0 and 28.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
380
0.5ml Quadrivalent influenza vaccine The inactivated split virion vaccines contained 15 μg of each hemagglutinin antigen of influenza A/H1N1, A/ H3N2, B/Victoria and B/Yamagata strains
Tingting and Yu
Tai’an, Shandong, China
seroconversion rate of hemagglutination inhibition (HI) antibodies
28 days after receiving one and two doses of vaccine in subjects aged 3-8 years, respectively. Seroconversion rate of HI antibodies against any subtype of influenza virus in each group.
Time frame: up to 56 days
seroprotection rate of HI antibodies
28 days after receiving one and two doses of vaccine in subjects aged 3-8 years, respectively. Seroprotection rate of HI antibodies against any subtype of influenza virus in each group.
Time frame: up to 56 days
geometric mean increase (GMI) of HI antibodies
28 days after receiving one and two doses of vaccine in subjects aged 3-8 years, respectively. GMI of HI antibodies against any subtype of influenza virus in each group.
Time frame: up to 56 days
The proportion of all adverse reactions/events
The proportion of all adverse reactions/events in subjects through 28 days after the second dose.
Time frame: up to 56 days
p value of difference of seroconversion rate in subjects with different immunization procedures
p value of the difference of seroconversion rate of HI antibodies at 28 days between subjects receiving one dose of vaccine and subjects receiving two.
Time frame: up to 56 days
p value of difference of seroprotection rate in subjects with different immunization procedures
p value of the difference of seroprotection rate of HI antibodies at 28 days between subjects receiving one dose of vaccine and subjects receiving two.
Time frame: up to 56 days
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p value of difference of GMI in subjects with different immunization procedures
p value of the difference of GMI of HI antibodies at 28 days between subjects receiving one dose of vaccine and subjects receiving two.
Time frame: up to 56 days
Reactogenicity Events
The proportion of all adverse reactions/events in subjects from the day subjects receiving the first dose of vaccine to 180 days after subjects receiving the second dose.
Time frame: 208 days