Acute Gastroenteritis caused by norovirus infection
Conditions
Interventions
Control group:Three doses of quadrivalent recombinant norovirus vaccine (Pichia pastoris) placebo were administered 30 days apart
Experimental group:Three doses of quadrivalent recombinant norovirus vaccine (Pichia pastoris) are administered 30 days apart
Sponsors
Guangxi Center for Disease Prevention and Control
Eligibility
Sex/Gender
All
Age
0.1 Years to 13 Years
Inclusion criteria
Inclusion criteria: (1) The subject's legal guardian agrees to participate in the study (subjects 8 years old and above also need their consent), can provide legal identification, have fully informed and signed informed consent, and understand and comply with the requirements of the trial protocol to participate in the follow-up; (2) The age range on the day of enrollment was 6 weeks old <= age <=13 years old, regardless of gender; (3) For those less than 12 months of age: 2.5kg<= birth weight <=4.5kg, 37 weeks <= gestation week <=42 weeks, normal labor (excluding severe abnormal labor and severe asphyxia rescue history)
Exclusion criteria
Exclusion criteria: (1) People who are allergic to or have a history of special reactions to any component of the experimental vaccine; Previous history of severe allergy to any vaccine or drug (such as anaphylactic shock, laryngeal edema, anaphylactic purpura, local anaphylactic necrosis reaction (Arthus reaction), dyspnea, angioneurotic edema, etc.); People with allergic constitution; (2) A history of confirmed norovirus infection within 2 years; (3) Have a history of any of the following diseases or are currently suffering from serious diseases: 1) Abnormal coagulation function: such as leukemia, congenital or acquired coagulation factor deficiency, aplastic anemia, thrombocytopenia and receiving anticoagulation therapy; 2) Diseases affecting local observation: such as rational jaundice; 3)Diseases affecting immune function: congenital or acquired immunodeficiency or a history of autoimmune disease; Uncontrolled lymphoproliferative diseases (such as chronic lymphocytic leukemia, Hodgkin's lymphoma, etc.); No spleen, or splenic surgery history, trauma history; 4) Now suffering from infectious diseases: such as tuberculosis, viral hepatitis, etc.; 5) Neurological and psychiatric diseases: epilepsy, congenital brain hypoplasia, brain trauma, brain tumor, infection, chemical and physical factors caused by brain nerve tissue damage, etc., psychiatric history and family history; 6)Other serious diseases that may interfere with the conduct or completion of the study: serious congenital malformations, severe developmental disorders, severe malnutrition, malignant tumors, congenital cardiovascular, liver, kidney diseases, etc.; (4) Had received blood or blood-related products (except hepatitis B immunoglobulin) within 1 month before enrollment; Long-term use of systemic immunosuppressants or other immunomodulatory drugs within 3 months (defined as use for more than 14 days); (5) Have participated in or are participating in other clinical trials (including drugs, biological products or devices) within 3 months prior to enrollment; (6) Where the investigator believes that the subject has any disease or condition that could put the subject at risk, poor adherence or inability to complete the trial as required by the protocol, and conditions that interfere with the evaluation of vaccine response.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cases of Acute Gastroenteritis (excluding co-infection with rotavirus and adenovirus) caused by the four genotypes included in the vaccine (GI.1, GII.3, GII.4, GII.17);Any occurrence of Adverse Event;The occurrence of solicited Adverse Event;Occurrence of unsolicited Adverse Event;Serious Adverse Event occurrence;IgG antibody against norovirus;Geometric mean Titer (GMT) of HBGA blocking antibodies;Geometric mean titer (GMT) growth multiple of HBGA blocking antibodies;HBGA blocks the positive turnover of antibody; | — |
Secondary
| Measure | Time frame |
|---|---|
| Protective efficacy against AGE caused by the four genotypes included in the vaccine (GI.1, GII.3, GII.4, GII.17);Protective efficacy against moderate to severe AGE caused by four genotypes included in the vaccine (GI.1, GII.3, GII.4, GII.17);Protective efficacy against AGE caused by any norovirus genotype;Protective efficacy against moderate-to-severe AGE caused by any norovirus genotype;Protective efficacy against AGE of exclusion of rotavirus/adenovirus co-infection caused by any norovirus genotype; | — |
Countries
China
Contacts
Public ContactLiwei Shi
Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention
Outcome results
None listed