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

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.