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

Exclusion Criteria

• •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;
• •Severe adverse reactions that are causally related to the previous dose of vaccination;
• •Other exclusion reasons considered by the investigator.