The study of quadrivalent influenza vaccine manufactured by Sinovac Biotech Co., Ltd will conduct in two phases,the phaseⅠclinical trial of the study will be open-label design,and the phase III clinical trial of the study will be randomized, double-blind, active controlled design.the purpose of this study is to evaluate the safety and immunogenicity of quadrivalent influenza vaccine in healthy subjects aged 6 to 35 months.
This study of quadrivalent influenza vaccine will be open-label design in phase Ⅰ and randomized, double-blind, active controlled design in phase III.The quadrivalent influenza vaccine was manufactured by Sinovac Biotech Co., Ltd. The purpose of this study is to evaluate the safety and immunogenicity of quadrivalent influenza vaccine(0.25ml and 0.5ml) manufactured by Sinovac Biotech Co., Ltd in healthy infants aged from 6 to 35 months. A total of 3330 subjects including 30 subjects in phase Ⅰ and 3300 subjects in phase III will be enrolled. The subjects in phase Ⅰ will receive 2 doses of quadrivalent influenza vaccine(0.5ml) on the immunization schedule of day 0,28.The subjects in phase III will be randomly assigned to 4 groups in a 2:2:1:1 ratio and subjects will receive two doses of quadrivalent influenza vaccine(0.25ml or 0.5ml) or trivalent influenza vaccine(BV or BY), respectively,on the immunization schedule of day 0,28 in each group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
217
7.5 ug hemagglutinin (HA) of each of the four influenza strains in 0.25 mL of sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate per injection.The routine of administration is Intramuscular injection into deltoid region.And the immunization schedule is two doses of quadrivalent influenza vaccine on day 0, 28.
15 ug hemagglutinin (HA) of each of the four influenza strains in 0.5 mL of sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate per injection.The routine of administration is Intramuscular injection into deltoid region.And the immunization schedule is two doses of quadrivalent influenza vaccine on day 0, 28.
Huaiyin Center for Diseases Control and Prevention
Huai'an, Jiangsu, China
Ganyu District Center for Disease Control and Prevention
Lianyungang, Jiangsu, China
Donghai District Center for Disease Prevention and Control
Lianyungang, Jiangsu, China
Binhai District Center for Disease Control and Prevention
Yancheng, Jiangsu, China
Immunogenicity index of seroconversion rate
HI antibody seroconversion rate 28 days after full schedule immunization
Time frame: 28 days after full schedule immunization
Immunogenicity index of seroprotection rate
HI antibody seroprotection rate 28 days after full schedule immunization
Time frame: 28 days after full schedule immunization
Immunogenicity index of GMT
HI antibody GMT increase folds 28 days after full schedule immunization
Time frame: 28 days after full schedule immunization
Safety index of the incidence of adverse reaction
Incidence of adverse reaction 0-28 days after each dose
Time frame: 0-28 days after each dose
Safety index of the incidence of adverse reaction
Incidence of adverse reaction 0-7 days after each dose
Time frame: 0-7 days after each dose
Safety index of the incidence of abnormal blood biochemical indexes
The incidence of abnormal blood biochemical indexes 3 days after each dose
Time frame: 3 days after each dose
Safety index of the incidence of SAE
Incidence of SAE since the beginning of vaccination until 6 months after full course vaccination
Time frame: Since the beginning of vaccination until 6 months after full course vaccination
Safety index of the incidence of AESI
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7.5μg inactivated influenza antigen (H1N1, H3N2, Victoria) of each of the trivalent influenza vaccine in 0.25 mL of sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate per injection.The routine of administration is Intramuscular injection into deltoid region.And the immunization schedule is two doses of quadrivalent influenza vaccine on day 0, 28.
7.5μg inactivated influenza antigen (H1N1, H3N2, and Yamagata) of each of the trivalent influenza vaccine in 0.25 mL of sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate per injection.The routine of administration is Intramuscular injection into deltoid region.And the immunization schedule is two doses of quadrivalent influenza vaccine on day 0, 28.
Incidence of AESI since the beginning of vaccination until 6 months after full course vaccination
Time frame: Since the beginning of vaccination until 6 months after full course vaccination