Status:
ACTIVE_NOT_RECRUITING
Clinical Trial of Protective Efficacy of Quadrivalent Recombinant Norovirus Vaccine (Pichia Pastoris)
Lead Sponsor:
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Conditions:
Acute Gastroenteropathy Due to Norovirus
Eligibility:
All Genders
6-13 years
Phase:
PHASE3
Brief Summary
The purpose of the research is to evaluate the protective efficacy, immunogenicity, and safety of quadrivalent recombinant norovirus vaccine (Pichia Pastoris) in people aged 6 weeks to 13 years.A tota...
Detailed Description
Overall design: A multicenter, randomized, double-blind, placebo-controlled trial was designed. The purpose of the research is to evaluate the protective efficacy, immunogenicity, and safety of quadr...
Eligibility Criteria
Inclusion
- The subject's legal guardian agrees to participate in the trial (consent is also required for subjects 8 years of age and older), and can provide proof of legal identity, is fully informed and has signed an informed consent form, and understands and complies with the requirements of the trial protocol to participate in the follow-up visits.
- The age of the subjects on the day of enrollment is not less than 6 weeks old and not more than 13 years old, regardless of gender.
- Those younger than 12 months of age: 2.5kg ≤ birth weight ≤ 4.5kg, 37 weeks ≤ weeks of gestation ≤ 42 weeks, born in normal labor (excluding severe abnormal labor and history of severe asphyxia resuscitation).
Exclusion
- Allergic to or having a history of specific reactions to any component of the investigational 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.
- A history of confirmed norovirus infection within 2 years.
- Have a history of any of the following diseases or are 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; ③Diseases affecting immune function: a history of congenital or acquired immunodeficiency or autoimmune disease; Uncontrolled lymphoproliferative diseases (such as chronic lymphocytic leukemia, Hodgkin's lymphoma, etc.); No spleen, or splenic surgery history, trauma history; ④Now suffering from infectious diseases: such as tuberculosis, viral hepatitis, etc； ⑤Neurological and psychiatric diseases: epilepsy, congenital brain hypoplasia, brain trauma, brain tumor, infection, brain nerve tissue damage caused by chemical and physical factors, etc., psychiatric history and family history； ⑥Other serious diseases that may interfere with the conduct or completion of the study: severe congenital malformations, severe developmental disorders, severe malnutrition, malignant tumors, congenital cardiovascular, liver, kidney diseases, etc.
- Received blood or blood-related products (other than hepatitis B immunoglobulin) within 1 month prior to enrollment; Long-term use of systemic immunosuppressants or other immunomodulatory drugs within 3 months (defined as use for more than 14 days).
- Have participated or are participating in other clinical trials (including drugs, biologics, or devices) within 3 months prior to enrollment.
- 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.
Key Trial Info
Start Date :
July 27 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 28 2027
Estimated Enrollment :
6600 Patients enrolled
Trial Details
Trial ID
NCT06524947
Start Date
July 27 2024
End Date
March 28 2027
Last Update
January 23 2025
Active Locations (3)
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1
Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention
Nanning, Guangxi, China, 530028
2
Hunan Center for Disease Control and Prevention
Changsha, Hunan, China, 410153
3
Sichuan Center for Disease Control and Prevention
Chengdu, Sichuan, China, 610041