The purpose of this study is to evaluate the Efficacy, Safety and Immunogenicity of the Human Norovirus Bivalent (GⅠ.1/GⅡ.4)Vaccine,Recombinant (Hansenula polymorpha) in Healthy People Aged 6 Months to 13 Years After Vaccination
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
8,000
Intramuscular injection of Human Norovirus Bivalent (GⅠ.1/GⅡ.4)Vaccine,Recombinant (Hansenula polymorpha) in the deltoid muscle of the upper arm
Intramuscular injection of placebo in the deltoid muscle of the upper arm
Laishui County Center for Disease Control and Prevention
Baoding, Hebei, China
Jingxing County Center for Disease Control and Prevention
Shijiazhuang, Hebei, China
Zhao County Center for Disease Control and Prevention
Shijiazhuang, Hebei, China
To evaluate efficacy of moderate/severe acute gastroenteritis caused by laboratory-confirmed (RT-PCR) infection with GI.1 or GII.4 norovirus after full vaccination with Human Norovirus Bivalent (GⅠ.1/GⅡ.4)Vaccine,Recombinant (Hansenula polymorpha)
Efficacy:The sum of the incidence rate of the placebo group and the incidence rate of the experimental group, divided by the incidence rate of the placebo group
Time frame: 14 days after the full course of vaccination to end of study(about two years)
To evaluate the efficacy of against moderate/severe acute gastroenteritis caused by laboratory-confirmed (RT-PCR) infection with any strain of norovirus
after full vaccination with Human Norovirus Bivalent (GⅠ.1/GⅡ.4)Vaccine,Recombinant (Hansenula polymorpha) Efficacy:The sum of the incidence rate of the placebo group and the incidence rate of the experimental group, divided by the incidence rate of the placebo group
Time frame: 14 days after the full course of vaccination to end of study(about two years)
To evaluate efficacy of any gastroenteritis caused by laboratory-confirmed (RT-PCR) infection with GI.1 or GII.4 norovirus after full vaccination with Human Norovirus Bivalent (GⅠ.1/GⅡ.4)Vaccine,Recombinant (Hansenula polymorpha)
Efficacy:The sum of the incidence rate of the placebo group and the incidence rate of the experimental group, divided by the incidence rate of the placebo group
Time frame: 14 days after the full course of vaccination to end of study(about two years)
To evaluate the efficacy of any gastroenteritis caused by laboratory-confirmed (RT-PCR) infection with any strain of norovirus after full vaccination with Human Norovirus Bivalent (GⅠ.1/GⅡ.4)Vaccine,Recombinant (Hansenula polymorpha)
Efficacy:The sum of the incidence rate of the placebo group and the incidence rate of the experimental group, divided by the incidence rate of the placebo group
Time frame: 14 days after the full course of vaccination to end of study(about two years)
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IgG of NoV GI.1 and GII.4 after full vaccination with Human Norovirus Bivalent (GⅠ.1/GⅡ.4)Vaccine,Recombinant (Hansenula polymorpha)
only Immunogenic subgroup
Time frame: 14th day after the full course of vaccination
HBGA-blocking antibody geometric mean titer (GMT) of NoV GI.1 and GII.4 after full vaccination with Human Norovirus Bivalent (GⅠ.1/GⅡ.4)Vaccine,Recombinant (Hansenula polymorpha)
only Immunogenic subgroup
Time frame: 14th day after the full course of vaccination
Positive conversion rates of GMT for NoV GI.1 and GII.4 after full vaccination with Human Norovirus Bivalent (GⅠ.1/GⅡ.4)Vaccine,Recombinant (Hansenula polymorpha)
only Immunogenic subgroup
Time frame: 14th day after the full course of vaccination
Compared to before vaccination,the growth multiple of GMT for NoV GI.1 and GII.4 antibodies after full vaccination with Human Norovirus Bivalent (GⅠ.1/GⅡ.4)Vaccine,Recombinant (Hansenula polymorpha)
only Immunogenic subgroup
Time frame: 14th day after the full course of vaccination
HBGA-blocking antibodies Geometric mean titer (GMT) of NoV GI.1 and GII.4 after full vaccination with Human Norovirus Bivalent (GⅠ.1/GⅡ.4)Vaccine,Recombinant (Hansenula polymorpha)
only Immunogenic subgroup
Time frame: 180th,360th,540th,720th day after the full course of vaccination
IgG of NoV GI.1 and GII.4 after full vaccination with Human Norovirus Bivalent (GⅠ.1/GⅡ.4)Vaccine,Recombinant (Hansenula polymorpha)
only Immunogenic subgroup
Time frame: 180th,360th,540th,720th day after the full course of vaccination
the incidence and severity of adverse reactions/events within 30 minutes after each dose of vaccination
Time frame: The period after each dose to 30 minutes after the dose
the incidence and severity of adverse reactions/events within 0-7 days after each dose of vaccination
Time frame: The period after each dose to 7 days after the dose
the incidence and severity of non-solicited adverse reactions/events within 28 days after each dose of vaccination
Time frame: The period after each dose to 28 days after the dose
the incidence of SAE from the first dose of vaccination to end of study
Time frame: the first dose of vaccination to end of study(about two years)