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

National Vaccine and Serum Institute

Status and phase: Not yet enrolling; Phase 3

Conditions: Norovirus Infections; Norwalk Gastroenteritis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05916326

CXSL1700011-III

Details and patient eligibility

About

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

Enrollment: 8,000 estimated patients

Sex: All

Ages: 6 months to 13 years old

Volunteers: Accepts Healthy Volunteers

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

First dose 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.

If items 1, 3, 13, 14, and 15 of the exclusion criteria are met, the volunteer's enrollment will be postponed.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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8,000 participants in 4 patient groups, including a placebo group

Experimental vaccine group

Experimental group

Treatment:

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

placebo group

Placebo Comparator group

Treatment:

Biological: placebo

Experimental vaccine group（Immunogenic subgroup ）

Experimental group

Treatment:

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

placebo group（Immunogenic subgroup）

Placebo Comparator group

Treatment:

Biological: placebo