Clinical Trial of Quadrivalent Recombinant Norovirus Vaccine (Pichia Pastoris)

This is an interventional prevention trial for Acute Gastroenteritis focused on measuring prevention Read More

Inclusion Criteria:

1. Compliance with this clinical trial observation age is 6 weeks old and above, and can provide legal identification;
2. The suspected and/or violating legal guardian has the ability to understand the research procedures and sign an informed consent form;
3. Correct and/or prevent the legal guardian who has the ability to read, understand, fill in the diary card/contact card, and promise to participate regularly in accordance with the research requirements;
4. The armpit body temperature of all people on the day of entry was <37.3℃;
5. Standards for some groups of people:<12 months of age: singleton full-term pregnancy (37-42 weeks gestational week) and birth weight 2.5-4.0kg; women of childbearing age: agree to take effective contraceptive measures within 6 months after the first dose is implanted to the full exemption.

Exclusion Criteria:

1. The population laboratory test indicators specified in the plan are abnormal and have clinical significance;
2. A history of severe allergies to any component of the test vaccine, including L-histidine, sodium chloride, aluminum hydroxide, such as: anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergies Necrotic reaction (Arthus reaction); or any previous history of severe side effects of vaccines or drugs, such as: allergies, urticaria, skin eczema, dyspnea, angioedema, etc.;
3. 3 days before vaccination, suffering from acute disease or in the acute attack of chronic disease (such as asthma, diabetes, thyroid disease, etc.);
4. Have taken antipyretic or analgesics within 24 hours before the first dose of vaccination;
5. Inoculate the inactivated vaccine within 7 days before the first dose of vaccine, and the live attenuated vaccine within 14 days;
6. People suffering from the following diseases:①Suffered from digestive system diseases (such as diarrhea, abdominal pain, vomiting, etc.) in the past 7 days;② Suffer from severe congenital malformations, severe developmental disorders, severe genetic defects, severe malnutrition, etc.;③ Suffering from thrombocytopenia, any coagulation disorders or receiving anticoagulant treatment and other intramuscular injection contraindications;④ Congenital or acquired immunodeficiency, or receive immunosuppressive therapy within 6 months (for example, systemic glucocorticoid prednisone or similar drugs have been used for more than 2 consecutive weeks within 6 months). Local medications (such as ointments, eye drops, inhalants or nasal sprays) should not exceed the recommended dose in the instructions or show any signs of systemic exposure;⑤ Has been diagnosed with infectious diseases, such as tuberculosis, viral hepatitis and/or human immunodeficiency virus (HIV) infection;⑥ Having convulsions, epilepsy, encephalopathy (such as congenital brain hypoplasia, brain trauma, brain tumor, cerebral hemorrhage, cerebral obstruction, infection, chemical drug poisoning, etc. caused brain nerve tissue damage, etc.) and a history of mental illness or family history;⑦ No spleen, functional asthenia, as well as any cause of asthenia or splenectomy;⑧ Suffering from severe cardiovascular disease (pulmonary heart disease, pulmonary edema), severe liver and kidney disease, diabetes with complications;
7. Have received blood or blood-related products, including immunoglobulins, within 3 months, or plan to use them during the study period (within 1 month after enrollment and full exemption);
8. Any research or unregistered products (drugs, vaccines, biological products or devices) have been used within 3 months before enrollment, or planned to be used during the research period;
9. Plan to move or leave the local area for a long time during the research period;
10. Any situation that the researcher believes may interfere with the evaluation of the research purpose;
11. Standards for certain groups of people:①<12 months old: IVF, multiple fetuses, currently suffering from perianal abscess, severe eczema, pathological jaundice, parents with HIV infection;② Persons ≥18 years of age: Physical examination before enrollment is hypertension (systolic blood pressure ≥140mmHg and/or diastolic blood pressure ≥90mmHg) or hypotension (systolic blood pressure <89mmHg) (regardless of medication);③Women of childbearing age: are breast-feeding or pregnant (including a positive urine pregnancy test) or have a pregnancy plan during the study period (in the group to within 6 months after the full exemption).