The purpose of this study is to evaluate the safety and immunogenicity of quadrivalent influenza vaccine in healthy children aged 6-35 months.
The study includes open-labelled phase I and randomized, double-blind, controlled phase III clinical trial. In the phase I, 20 healthy Chinese children aged 6-35 months were administered with two doses of QIV (7.5μg/0.25ml). In the phase Ⅲ clinical trial, 2320 children were assigned to QIV group, TIV (B/Victoria) group and TIV (B/Yamagata) group in a 2:1:1 ratio. All vaccines were manufactured by Sinovac Biotech Co., Ltd.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
2,340
One dose of quadrivalent influenza vaccine: 0.25 ml per dose containing 7.5μg antigen.
One dose of quadrivalent influenza vaccine: 0.25 ml per dose containing 7.5μg antigen.
One dose of trivalent influenza vaccine (contains B/Victoria strain): 0.25 ml per dose containing 7.5μg antigen.
Guanyun Center for Disease Prevention and Control
Lianyungang, Jiangsu, China
Pizhou Center for Disease Prevention and Control
Pizhou, Jiangsu, China
The lower limit of 95% confidence intervals (95%CI) of geometric mean titer (GMT) ratio (experimental group/control group) of hemagglutination inhibition (HI) antibody titer≥2/3.
Immunogenicity index, One of the standard to evaluate the experimental vaccine is non-inferior to the control vaccines.
Time frame: 28 days after two doses immunization
The lower limit of 95% CI of the seroconversion rate difference (experimental group-control group)≥-10%.
Immunogenicity index, Another standard to evaluate the experimental vaccine is non-inferior to the control vaccines.
Time frame: 28 days after two doses immunization
The lower limit of 95%CI of the ratio of GMT (experimental group/control group) >1.5.
Immunogenicity index, One of the standard to evaluate the experimental vaccine is superior to the control vaccines for specific antigen type.
Time frame: 28 days after two doses immunization
The lower limit of 95% CI of the difference of HI antibody seroconversion rate (experimental group-control group)>10%
Immunogenicity index, Another standard to evaluate the experimental vaccine is superior to the control vaccines for specific antigen type.
Time frame: 28 days after two doses immunization
The lower limit of 95% CI of seroconversion rate for each HI antibody after two doses immunization≥40%.
Immunogenicity index
Time frame: 28 days after two doses immunization
The seroprotective rate (HI antibody titer≥1:40) of each HI antibody after two doses immunization≥70%.
Immunogenicity index
Time frame: 28 days after two doses immunization
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One dose of trivalent influenza vaccine (contains B/Yamagata strain): 0.25 ml per dose containing 7.5μg antigen.
The geometric mean increase (GMI) of each HI antibody after two doses immunization >2.5.
Immunogenicity index
Time frame: 28 days after two doses immunization
The lower limit of 95%CI of the ratio of GMT(experimental group/control group)≥2/3, in the subjects whose pre-immune HI antibody titer<1:40
Immunogenicity index
Time frame: 28 days after two doses immunization
The lower limit of 95% CI of the difference of HI antibody seroconversion rate (experimental group-control group)≥-10%, in the subjects whose pre-immune HI antibody titer<1:40.
Immunogenicity index
Time frame: 28 days after two doses immunization
The incidence of the solicited local and general adverse reactions 0-7 days after each immunization.
Safety index, The adverse reactions refers to the adverse events which were considered related to the vaccination.
Time frame: 0-7 days
The incidence of the unsolicited adverse events 0-28 days after each immunization
Safety Index
Time frame: 0-28 days after each dose immunization
The incidence of the serious adverse events within 7 months after the first immunization.
Safety Index
Time frame: Within 7 months after the first dose immunization