A phase III clinical trial of the study of quadrivalent influenza vaccine developed by Sinovac Biotech will be conducted in Chinese children aged 6 to 35 months. The trial is an randomized, double-blind and active controlled study. The objective of this study is to evaluate the Immunogenicity and safety of the vaccine.
A phase III clinical trial of the study of quadrivalent influenza vaccine developed by Sinovac Biotech will be conducted in Chinese children aged 6 to 35 months. The trial is an randomized, double-blind and active controlled study. The objective 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 3300 subjects will be enrolled. The subjects 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, according to the immunization schedule of day 0,28 in each group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
3,300
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 njection.The routine of administration is Intramuscular injection into deltoid region.And the immunization schedule is two doses 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 njection.The routine of administration is Intramuscular injection into deltoid region.And the immunization schedule is two doses on day 0, 28.
Huoqiu County Center for Disease Control and Prevention
Lu'an, Anhui, China
Zhushan County Center for Diseases Control and Prevention
Shiyan, Hubei, China
Nanzhang County Center for Disease Prevention and Control
Xiangyang, Hubei, China
Laohekou Center for Disease Control and Prevention
Xiangyang, Hubei, China
Seroconversion rates of HI antibody
Anti-influenza antibodies were measured using HAI assay for 4 strains: H1N1, H3N2, B Victoria and B Yamagata. Seroconversion was defined as pre-vaccination titer \<1:10 and post-vaccination titer ≥1:40, and Significant increase was defined as pre-vaccination titer≥1:40 and ≥ 4-fold increase of post-vaccination titer.
Time frame: 28 days after full schedule immunization
Geometric Mean Titers (GMTs) of HI antibody
Anti-influenza antibody levels were measured using hemagglutination inhibition (HAI) assay for 4 strains: H1N1, H3N2, B Victoria, B Yamagata.
Time frame: 28 days after full schedule immunization
Number of Participants With Seroprotection to Influenza Vaccine Antigens
Anti-influenza antibodies were measured using HAI assay for 4 strains: H1N1, H3N2, B Victoria and B Yamagata. Seroprotection was defined as an antibody titer ≥1:40 at pre-vaccination and at post-final vaccination.
Time frame: 28 days after full schedule immunization
GMIs of HI antibody
Anti-influenza antibody were measured using hemagglutination inhibition (HAI) assay for 4 strains: H1N1, H3N2, B Victoria, B Yamagata. GMI is the increase fold of GMT post vaccination compared with pre vaccination
Time frame: 28 days after full schedule immunization
Incidence of adverse reactions
Incidence of adverse reaction 0-30 days after each dose
Time frame: 0-30 days after each dose
Incidence of adverse reactions
Incidence of adverse reaction 0-7 days after each dose
Time frame: 0-7 days after each dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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 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 vaccine on day 0, 28.
Zigui County Center for Disease Control and Prevention
Yichang, Hubei, China
Incidence of Serious adverse events
Incidence of serious adverse events from beginning of vaccination until 6 months after the last dose
Time frame: Since the beginning of vaccination until 6 months after the last dose
Incidence of AESI
Incidence of AESI since the beginning of vaccination until 6 months after the last dose
Time frame: since the beginning of vaccination until 6 months after the last dose