Norovirus Infections, Norwalk Gastroenteritis
Conditions
Brief summary
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
Interventions
BIOLOGICALHuman Norovirus Bivalent (GⅠ.1/GⅡ.4)Vaccine，Recombinant (Hansenula polymorpha)
Intramuscular injection of Human Norovirus Bivalent (GⅠ.1/GⅡ.4)Vaccine，Recombinant (Hansenula polymorpha) in the deltoid muscle of the upper arm
BIOLOGICALplacebo
Intramuscular injection of placebo in the deltoid muscle of the upper arm
Sponsors
Lanzhou Institute of Biological Products Co., Ltd
National Vaccine and Serum Institute, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Months to 13 Years
Healthy volunteers
Yes
Inclusion criteria
* Aged from 6 months to 13 years old, and can provide legal identity certificate; * Volunteers and/or their guardians have the ability to understand the study requirements and process, agree to participate in the clinical trial and sign the informed consent, and can participate in all planned follow-up visits ( by an authorized entrusted person on the premise of written authorization by the guardian the informed consent can be signed); * Those \<12 months old: born in full-term pregnancy (gestational week 37-42 weeks) and birth weight ≥ 2.5kg.
Exclusion criteria
First dose
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 14 days after the full course of vaccination to end of study（about two years） | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 14 days after the full course of vaccination to end of study（about two years） | 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 |
| 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) | 14 days after the full course of vaccination to end of study（about two years） | 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 |
| IgG of NoV GI.1 and GII.4 after full vaccination with Human Norovirus Bivalent (GⅠ.1/GⅡ.4)Vaccine，Recombinant (Hansenula polymorpha) | 14th day after the full course of vaccination | only Immunogenic subgroup |
| 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) | 14th day after the full course of vaccination | only Immunogenic subgroup |
| 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) | 14th day after the full course of vaccination | only Immunogenic subgroup |
| To evaluate the efficacy of against moderate/severe acute gastroenteritis caused by laboratory-confirmed (RT-PCR) infection with any strain of norovirus | 14 days after the full course of vaccination to end of study（about two years） | 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 |
| 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) | 180th,360th,540th,720th day after the full course of vaccination | only Immunogenic subgroup |
| 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） | — |
| 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) | 14th day after the full course of vaccination | only Immunogenic subgroup |
Countries
China
Outcome results
None listed