Trials Sponsors Conditions Drugs Pricing

Conditions

Norovirus Infections Norwalk Gastroenteritis

Outcome Measures

Primary Outcomes (7)

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
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
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
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

Secondary Outcomes (4)

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
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

Study Arms (15)

18-59 years old group A

EXPERIMENTAL

Biological: middle-dose Norovirus Bivalent (GI.1 / GII.4) Vaccine

18-59 years old group B

EXPERIMENTAL

Biological: high-dose Norovirus Bivalent (GI.1 / GII.4) Vaccine

18-59 years old group C

PLACEBO COMPARATOR

Biological: placebo

6-17 years old group A

Interventions

middle-dose Norovirus Bivalent (GI.1 / GII.4) VaccineBiological

Intramuscular injection of middle-dose Norovirus Bivalent (GI.1 / GII.4) Vaccine in the deltoid muscle of the upper arm

18-59 years old group A3-5 years old group A6-17 years old group A6-35 months old group A6-35 months old group D

high-dose Norovirus Bivalent (GI.1 / GII.4) VaccineBiological

Eligibility Criteria

Age6 Months - 59 Years

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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;

Sponsors & Collaborators

Beijing Zhong Sheng Heng Yi Pharmaceutical Technology Co., Ltd.
Type not reportedcollaborator
Lanzhou Institute of Biological Products Co., Ltd
Industrycollaborator

Study Sites (1)

qixian Center for Disease Control and Prevention

Hebi, Henan, China

RECRUITING

dacheng zhanCONTACT15803925825

MeSH Terms

Conditions

Caliciviridae Infections

Interventions

Vaccines

Condition Hierarchy (Ancestors)

RNA Virus InfectionsVirus DiseasesInfections

Intervention Hierarchy (Ancestors)

Biological ProductsComplex Mixtures

Central Study Contacts

Xia shengli, bachelor

CONTACT

（+86）13592610137 1792865518@qq.com

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 18, 2021

First Posted

June 28, 2021

Study Start

June 30, 2021

Actual (reported)

Primary Completion

February 28, 2024

Estimated (date passed)

You may not qualify if:

Axillary body temperature is not less than 37.3℃ (older than 14 years) before vaccination, and axillary body temperature is not less than 37.5℃ (14 years or younger) before vaccination;
Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc;
Have received immune enhancement or inhibitor therapy within 3 months (continuous oral or instillation for more than 14 days);
Have been diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases;
Having serious congenital malformations or chronic diseases (including but not limited to:Down syndrome, thalassemia, heart disease, kidney disease, diabetes, autoimmune disease, genetic allergies, Guillain Barre syndrome, etc.);
Asthenia or splenectomy, functional asthenia caused by any situation;
Severe liver and kidney disease, severe cardiovascular disease, drug-uncontrollable hypertension (systolic blood pressure is not less than 140mmHg, diastolic blood pressure is not less than 90mmHg), high blood glucose, diabetic complications , Malignant tumors, various acute diseases or acute attacks of chronic diseases;
Have a history of chronic gastrointestinal disease, current diarrhea or other digestive system diseases, gastroenteritis requiring treatment in the past 7 days;
Have a history of abnormal coagulation function (such as coagulation factor deficiency, coagulopathy);
Have a history of severe allergic reactions to vaccination; allergic to any component of the experimental vaccine
Have received a live attenuated vaccine within 28 days before vaccination, or received other vaccines（Recombinant vaccine, subunit vaccine, inactivated vaccine） within 14 days before vaccination;
Received within 6 months before vaccination or plan to receive other study drugs in the near future
Plan to move before the end of the study or leave the local area for a long time during the scheduled study visit; Other conditions considered by the investigator to be inappropriate for participation in the study.
Children aged 24 months and under are born prematurely (delivered before the 37th week of pregnancy), low-weight (birth weight for girls \<2300g, boys \<2500g) infants; Children 24 months of age and younger have a history of dystocia, birth asphyxia or other reasons, a history of neurological damage, severe chronic diseases (such as Down syndrome, sickle cell anemia, or neurological disorders).
Have a high fever (axillary temperature is not less than 39.0℃) for three days and severe allergic reaction after the previous dose of vaccination;
+1 more criteria

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (7)

Secondary Outcomes (4)

Study Arms (15)

18-59 years old group A

18-59 years old group B

18-59 years old group C

6-17 years old group A

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

6-17 years old group B

6-17 years old group C

3-5 years old group A

3-5 years old group B

3-5 years old group C

6-35 months old group A

6-35 months old group B

6-35 months old group C

6-35 months old group D

6-35 months old group E

6-35 months old group F

You may not qualify if:

Data Sharing

Source record

Locations