Acute gastroenteritis caused by norovirus
Conditions
Interventions
adults:low dose
adults:high dose
adults:Placebo (with aluminum)
teenagers:low dose
teenagers:high dose
teenagers:Placebo (with aluminum)
elderly(60 years old and above):low dose
elderly(60 years old and above):high dose
elderly(60 years old and above):Placebo (with aluminum)
elderly(60 years old and above):Placebo (without aluminum)
Toddler :low dose
Toddler:high dose
Toddler:Placebo (with aluminum)
Infants(6 weeks old-2 years old):low dose
Infants(6 weeks old-2 years old):high dose
Infants(6 weeks old-2 years old):Placebo (with aluminum)
Infants(6 weeks old-2 years old):Placebo (without aluminum)
Sponsors
Guangxi Zhuang Autonomous Region Centre for Disease Control and Prevention
Eligibility
Sex/Gender
All
Inclusion criteria
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
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:?Suffered from digestive system diseases (such as diarrhea, abdominal pain, vomiting, etc.) in the past 7 days;? Suffer from severe congenital malformations, severe developmental disorders, severe genetic defects, severe malnutrition, etc.;? Suffering from thrombocytopenia, any coagulation disorders or receiving anticoagulant treatment and other intramuscular injection contraindications;? 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;? Has been diagnosed with infectious diseases, such as tuberculosis, viral hepatitis and/or human immunodeficiency virus (HIV) infection;? 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;? No spleen, functional asthenia, as well as any cause of asthenia or splenectomy;? 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:?<12 months old: IVF, multiple fetuses, currently suffering from perianal abscess, severe eczema, pathological jaundice, parents with HIV infection;? 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);?Women of childbearing age: are breast-feeding or pregnant (including a positive urine pre
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of AEs;Incidence of SAEs;Incidence of SARs;Anti-Norovirus (G?.1/G?.3/G?.4/G?.17) IgA 4-fold growth rate;Anti-Norovirus (G?.1/G?.3/G?.4/G?.17) IgG 4-fold growth rate;Anti-norovirus (G?.1/G?.3/G?.4/G?.17) HBGA positive conversion rate; | — |
Countries
China
Contacts
Public ContactTeng Huang
Guangxi Centre for Disease Control and Prevention
Outcome results
None listed