Norovirus Infections, Norwalk Gastroenteritis
Conditions
Brief summary
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.
Interventions
BIOLOGICALmiddle-dose Norovirus Bivalent (GI.1 / GII.4) Vaccine
Intramuscular injection of middle-dose Norovirus Bivalent (GI.1 / GII.4) Vaccine in the deltoid muscle of the upper arm
BIOLOGICALhigh-dose Norovirus Bivalent (GI.1 / GII.4) Vaccine
Intramuscular injection of high-dose Norovirus Bivalent (GI.1 / GII.4) Vaccine 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
Beijing Zhong Sheng Heng Yi Pharmaceutical Technology Co., Ltd.
Zhengzhou University
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 59 Years
Healthy volunteers
Yes
Inclusion criteria
* Age range: healthy people aged 6 months -59 years and and older who can provide legal identification; * Inquired about medical history and physical examination, the investigator judged that the health condition is good; * The subject and/or his legal guardian and/or his entrusted person can understand the study procedures and informed consent, voluntarily sign informed consent form, and be able to comply with the requirements of the clinical study protocol; * Females of childbearing age (menarche to menopause) are not pregnant at the time of enrollment (negative urine pregnancy test), not breastfeeding, and have no birth plan within 12 months after enrollment; effective contraception will be taken within 2 weeks before enrollment;
Exclusion criteria
First Dose
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antibody titer of（NoV GI.1 and GII.4 HBGA-blocking antibody）on the 14th day after the full course of vaccination | 14th day after the full course of vaccination | — |
| the incidence and severity of non-collective adverse reactions/events within 30 days after each dose of vaccination | through 30 days after each dose | If there is still next vaccination ，collect the incidence and severity of non-collective adverse reactions/events within vaccination interval（28 days） after vaccination |
| the incidence of SAE from the first dose of vaccination to 6 months after the full course of vaccination | 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 | 14th day after the full course of vaccination | — |
| 4-fold Seroconversion rate on the 14th day after the full course of vaccination | 14th day after the full course of vaccination | — |
| the incidence and severity of any adverse reactions/events within 30 minutes after each dose of vaccination | through 30 minutes after each dose | — |
| the incidence and severity of adverse reactions/events within 0-7 days after each dose of vaccination | through 7 days after each dose | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | 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 | 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 | 90th,180th,270th,360th,540th,720th 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 | 14th day after the full course of vaccination |
Countries
China
Contacts
Primary ContactXia shengli, bachelor
Outcome results
None listed