NCT05916326

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8,000

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

3 active sites

Status
completed

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 6, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 23, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

June 30, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 27, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2025

Completed
Last Updated

January 16, 2026

Status Verified

December 1, 2025

Enrollment Period

2.1 years

First QC Date

June 6, 2023

Last Update Submit

January 15, 2026

Conditions

Norovirus InfectionsNorwalk Gastroenteritis

Outcome Measures

Primary Outcomes (1)

  • 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）

Secondary Outcomes (13)

  • 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）

  • 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）

  • 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）

  • 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

  • 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

  • +8 more secondary outcomes

Study Arms (4)

Experimental vaccine group

EXPERIMENTAL
Biological: Human Norovirus Bivalent (GⅠ.1/GⅡ.4)Vaccine，Recombinant (Hansenula polymorpha)

placebo group

PLACEBO COMPARATOR
Biological: placebo

Experimental vaccine group（Immunogenic subgroup ）

EXPERIMENTAL
Biological: Human Norovirus Bivalent (GⅠ.1/GⅡ.4)Vaccine，Recombinant (Hansenula polymorpha)

placebo group（Immunogenic subgroup）

PLACEBO COMPARATOR
Biological: placebo

Interventions

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

Experimental vaccine groupExperimental vaccine group（Immunogenic subgroup ）
placeboBIOLOGICAL

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

placebo groupplacebo group（Immunogenic subgroup）

Eligibility Criteria

Age6 Months - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Axillary body temperature \> 37.0°C ;
  • Have a history of chronic gastrointestinal diseases;
  • Had gastroenteritis requiring treatment or current diarrhea, vomiting or other digestive system diseases within 7 days;
  • Have a history of allergy to any excipients of the experimental vaccine (L-histidine, sodium chloride, aluminum hydroxide and water for injection, etc.);
  • Have a history of severe allergy to any vaccine or drug, such as anaphylactic shock, allergic laryngeal edema, allergic purpura, Arthus reaction;
  • Have been diagnosed with congenital or acquired immunodeficiency, or received immunosuppressant treatment, such as the application of systemic glucocorticoid therapy for more than 2 consecutive weeks 2 months before vaccination, such as prednisone or similar drugs \> 5mg/day (note: use of topical and inhaled/nebulized steroids can participate);
  • Infectious diseases, such as: tuberculosis, viral hepatitis or parents infected with human immunodeficiency virus HIV;
  • Thrombocytopenia, any coagulation disorders, or intramuscular injection contraindications receiving anticoagulant therapy etc.;
  • The volunteer himself or his biological parents have a history of convulsions (except for febrile convulsions in children), epilepsy and mental illness;
  • Serious diseases or congenital malformations that may interfere with the conduct or completion of the research (including but not limited to: asthma and other respiratory diseases or during the attack of chronic bronchitis, Down syndrome, thalassemia, heart disease, encephalopathy, kidney disease, self immune diseases, genetic allergies, Guillain-Barre Syndrome, severe skin diseases, severe malnutrition, severe developmental disorders, etc.);
  • Asplenia, functional asplenia, and asplenia or splenectomy caused by any reason;
  • Have received blood or blood-related products or immune globulin within 3 months (hepatitis B immune globulin and rabies patient immune globulin are acceptable);
  • vaccinated inactivated/recombinant vaccines (non-live vaccines) within 7 days, and inoculate live attenuated vaccines or COVID-19 vaccines within 14 days;
  • Acute illness or acute exacerbation of chronic disease within 3 days;
  • Have taken antipyretic, analgesic or antiallergic drugs within 3 days;
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Laishui County Center for Disease Control and Prevention

Baoding, Hebei, China

Location

Jingxing County Center for Disease Control and Prevention

Shijiazhuang, Hebei, China

Location

Zhao County Center for Disease Control and Prevention

Shijiazhuang, Hebei, China

Location

MeSH Terms

Conditions

Caliciviridae Infections

Condition Hierarchy (Ancestors)

RNA Virus InfectionsVirus DiseasesInfections

Study Design

Study Type
interventional
Phase
phase 3
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 6, 2023

First Posted

June 23, 2023

Study Start

June 30, 2023

Primary Completion

July 27, 2025

Study Completion

July 27, 2025

Last Updated

January 16, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(3)