A randomized, blind, positive vaccine control trial was designed.A total of 2550 subjects aged 6-35 months were randomly assigned to the low dose (0.25ml/ dose) group, the high dose (0.5ml/ dose) group and the control group in a ratio of 1:1:1. They were inoculated with 2 doses of quadrivalent influenza virus split vaccine (experimental vaccine or control vaccine) at 0 and 28 days of immunization program to observe the Immunogenicity and safety.
A randomized, blind, positive vaccine control trial was designed.A total of 2550 subjects aged 6-35 months were randomly assigned to the low dose (0.25ml/ dose) group, the high dose (0.5ml/ dose) group and the control group in a ratio of 1:1:1. They were inoculated with 2 doses of quadrivalent influenza virus split vaccine (experimental vaccine or control vaccine) at 0 and 28 days of immunization program to observe the Immunogenicity and safety. Immunogenicity observation Venous blood (2.5-3.0ml) was collected from all subjects before the first dose and 30 days after the full dose, and serum was separated for detection of Hemagglutination Inhibition antibodies against four influenza virus serotypes (H1N1, H3N2, B (V), B (Y)). Safety observation All AE within 30 minutes of each dose, solicited adverse events at 0-7 days, non-solicited adverse events at 0-28 days (first dose) /30 days (second dose), and all serious adverse events from the first dose to 6 months after the full dose were collected.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
2,550
Subjects were vaccinated with a dose of low-dose Investigational vaccine on day 0 and day 28 respectively.The site of inoculation for infants aged 6-11 months is the anterolateral thigh, and the site of inoculation for infants aged 12-35 months is the lateral deltoid muscle of the upper arm.
Subjects were vaccinated with a dose of high-dose Investigational vaccine on day 0 and day 28 respectively.The site of inoculation for infants aged 6-11 months is the anterolateral thigh, and the site of inoculation for infants aged 12-35 months is the lateral deltoid muscle of the upper arm.
Hunan Provincial Center for Disease Control and Prevention
Changsha, Hunan, China
Immunogenicity end point 1
30 days after the whole vaccination, the seroconversion rate of serum Hemagglutination Inhibition antibodies of influenza viruses H1N1, H3N2, B(V) and B(Y) were observed.
Time frame: 30 days after the whole vaccination
Immunogenicity end point 2
30 days after the whole vaccination, the geometric mean titer of serum Hemagglutination Inhibition antibodies of influenza viruses H1N1, H3N2, B(V) and B(Y) were observed.
Time frame: 30 days after the whole vaccination
Immunogenicity end point 3
30 days after the whole vaccination, the seroprotection rate of serum Hemagglutination Inhibition antibodies of influenza viruses H1N1, H3N2, B(V) and B(Y) were observed.
Time frame: 30 days after the whole vaccination
Immunogenicity end point 4
30 days after the whole vaccination, the geometric mean increase of serum Hemagglutination Inhibition antibodies of influenza viruses H1N1, H3N2, B(V) and B(Y) were observed.
Time frame: 30 days after the whole vaccination
Safety end point 1
Incidence and severity distribution of all adverse events within 30 days from the first dose to the whole course of vaccination.
Time frame: Within 30 days from the first dose to the whole course of vaccination
Safety end point 2
Incidence and severity distribution of total AE within 30 minutes after each dose.
Time frame: Within 30 minutes after each dose
Safety end point 3
Incidence and severity distribution of conscriptive adverse events within 7 days after each dose.
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Subjects were vaccinated with a dose of active compared vaccine on day 0 and day 28 respectively.The site of inoculation for infants aged 6-11 months is the anterolateral thigh, and the site of inoculation for infants aged 12-35 months is the lateral deltoid muscle of the upper arm.
Time frame: Within 7 days after each dose
Safety end point 4
Incidence and severity distribution of non-aggregative adverse events within 0-28 days after first dose vaccination and 0-30 days after second dose vaccination.
Time frame: Within 0-28 days after first dose vaccination and 0-30 days after second dose vaccination
Safety end point 5
Incidence of serious adverse events within 6 months from the first dose to the whole course of vaccination.
Time frame: Within 6 months from the first dose to the whole course of vaccination