NCT04941261

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,716

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 28, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

June 30, 2021

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2024

Completed
Last Updated

October 28, 2022

Status Verified

May 1, 2022

Enrollment Period

2.7 years

First QC Date

June 18, 2021

Last Update Submit

October 26, 2022

Conditions

Norovirus InfectionsNorwalk 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

  • 4-fold Seroconversion rate 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 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

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

6-17 years old group B

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

6-17 years old group C

PLACEBO COMPARATOR
Biological: placebo

3-5 years old group A

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

3-5 years old group B

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

3-5 years old group C

PLACEBO COMPARATOR
Biological: placebo

6-35 months old group A

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

6-35 months old group B

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

6-35 months old group C

PLACEBO COMPARATOR
Biological: placebo

6-35 months old group D

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

6-35 months old group E

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

6-35 months old group F

PLACEBO COMPARATOR
Biological: placebo

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

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

18-59 years old group B3-5 years old group B6-17 years old group B6-35 months old group B6-35 months old group E
placeboBIOLOGICAL

Intramuscular injection of placebo in the deltoid muscle of the upper arm

18-59 years old group C3-5 years old group C6-17 years old group C6-35 months old group C6-35 months old group F

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;
  • 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;

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

qixian Center for Disease Control and Prevention

Hebi, Henan, China

RECRUITING

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）135926101371792865518@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

Primary Completion

February 28, 2024

Study Completion

March 30, 2024

Last Updated

October 28, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)