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| Name | Class |
|---|---|
| Lanzhou Institute of Biological Products Co., Ltd | INDUSTRY |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental vaccine group | Experimental |
| |
| placebo group | Placebo Comparator |
| |
| Experimental vaccine group(Immunogenic subgroup ) | Experimental |
| |
| placebo group(Immunogenic subgroup) | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human Norovirus Bivalent (GⅠ.1/GⅡ.4)Vaccine,Recombinant (Hansenula polymorpha) | Biological | Intramuscular injection of Human Norovirus Bivalent (GⅠ.1/GⅡ.4)Vaccine,Recombinant (Hansenula polymorpha) in the deltoid muscle of the upper arm |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 14 days after the full course of vaccination to end of study(about two years) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
First dose exclusion criteria:
If items 1, 3, 13, 14, and 15 of the exclusion criteria are met, the volunteer's enrollment will be postponed.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laishui County Center for Disease Control and Prevention | Baoding | Hebei | China | |||
| Jingxing County Center for Disease Control and Prevention |
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| placebo | Biological | Intramuscular injection of placebo in the deltoid muscle of the upper arm |
|
| 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 | 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 | 14 days after the full course of vaccination to end of study(about two years) |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | the first dose of vaccination to end of study(about two years) |
| Shijiazhuang |
| Hebei |
| China |
| Zhao County Center for Disease Control and Prevention | Shijiazhuang | Hebei | China |
| ID | Term |
|---|---|
| D017250 | Caliciviridae Infections |
| ID | Term |
|---|---|
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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