Phase III Clinical Trial to Evaluate the Human Norovirus Bivalent (GⅠ.1/GⅡ.4)Vaccine，Recombinant (Hansenula Polymorpha)

NCT ID: NCT05916326

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 8000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-30
• Study Completion Date: 2025-07-27

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

Conditions

Norovirus Infections; Norwalk Gastroenteritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Experimental vaccine group

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

Intramuscular injection of Human Norovirus Bivalent (GⅠ.1/GⅡ.4)Vaccine，Recombinant (Hansenula polymorpha) in the deltoid muscle of the upper arm

placebo group

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: BIOLOGICAL

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

Experimental vaccine group（Immunogenic subgroup ）

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

Intramuscular injection of Human Norovirus Bivalent (GⅠ.1/GⅡ.4)Vaccine，Recombinant (Hansenula polymorpha) in the deltoid muscle of the upper arm

placebo group（Immunogenic subgroup）

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: BIOLOGICAL

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

Interventions

Human 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

Intervention Type: BIOLOGICAL

placebo

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• 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;
• Plan to move before the end of the study or leave the local area for a long time during the scheduled study visit;
• Participating in or planning to participate in another interventional research during the study process;
• The investigators believe that the volunteers have other conditions that may interfere with the evaluation of the research purpose;
• <12 months old: the baby is born with abnormal labor process (dystocia, instrumental midwifery) or has a history of suffocation, nervous system damage, current pathological jaundice, perianal abscess, severe eczema;
• If there have been serious adverse reactions after vaccination in the past, the investigator will determine whether the volunteer is enrolled or not according to the actual situation.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lanzhou Institute of Biological Products Co., Ltd

INDUSTRY

Sponsor Role: collaborator

National Vaccine and Serum Institute, China

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Laishui County Center for Disease Control and Prevention

Baoding, Hebei, China

Jingxing County Center for Disease Control and Prevention

Shijiazhuang, Hebei, China

Zhao County Center for Disease Control and Prevention

Shijiazhuang, Hebei, China

Countries

China

Other Identifiers

CXSL1700011-III

Identifier Type: -

Identifier Source: org_study_id