Phase II clinical study will explore dose and safety, immunogenicity in 4 age groups, including 18-59 years old group, 6-17 years old group, 3-5 years old group, 6-35 months old group, with a total of 1716 subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
1,716
Intramuscular injection of middle-dose Norovirus Bivalent (GI.1 / GII.4) Vaccine in the deltoid muscle of the upper arm
Intramuscular injection of high-dose Norovirus Bivalent (GI.1 / GII.4) Vaccine in the deltoid muscle of the upper arm
Intramuscular injection of placebo in the deltoid muscle of the upper arm
qixian Center for Disease Control and Prevention
Hebi, Henan, China
RECRUITINGthe incidence and severity of any adverse reactions/events within 30 minutes after each dose of vaccination
Time frame: through 30 minutes after each dose
the incidence and severity of adverse reactions/events within 0-7 days after each dose of vaccination
Time frame: through 7 days after each dose
the incidence and severity of non-collective adverse reactions/events within 30 days after each dose of vaccination
If there is still next vaccination ,collect the incidence and severity of non-collective adverse reactions/events within vaccination interval(28 days) after vaccination
Time frame: through 30 days after each dose
the incidence of SAE from the first dose of vaccination to 6 months after the full course of vaccination
Time frame: up to 6 months after the full course of vaccination
Antibody titer of HBGA-blocking antibody on the 14th day after the full course of vaccination
Time frame: 14th day after the full course of vaccination
4-fold Seroconversion rate on the 14th day after the full course of vaccination
Time frame: 14th day after the full course of vaccination
Antibody titer of(NoV GI.1 and GII.4 HBGA-blocking antibody)on the 14th day after the full course of vaccination
Time frame: 14th day after the full course of vaccination
Geometric mean Titer of(NoV GI.1 and GII.4 HBGA-blocking antibody)on the 14th day after the full course of vaccination
Time frame: 14th day after the full course of vaccination
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Immune response(compared with before vaccination, the antibody increased by 4 times or more) rate of(NoV GI.1 and GII.4 HBGA-blocking antibody)on the 14th day after the full course of vaccination
Time frame: 14th day after the full course of vaccination
Antibody titer of(NoV GI.1 and GII.4 HBGA-blocking antibody)on 90th,180th,270th,360th,540th,720th day after the full course of vaccination
Time frame: 90th,180th,270th,360th,540th,720th day after the full course of vaccination
Binding Antibody (IgG) on 90th,180th,270th,360th,540th,720th day after the full course of vaccination
Time frame: 90th,180th,270th,360th,540th,720th day after the full course of vaccination