A Clinical Trial to Evaluate the Safety and Immunogenicity of Norovirus Bivalent Vaccine
NCT ID: NCT04188691
Last Updated: 2021-04-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
510 participants
INTERVENTIONAL
2019-11-28
2020-12-13
Brief Summary
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The 18-59-year-old, 6-17-year-old, and 3-5-year-old age groups were vaccinated 2 times at a time interval of 28 days. The 6-35 month age group is divided into two groups, Group 1 is inoculated with 2 doses interval of 28 days each, and Group 2 is inoculated with 3 doses interval of 28 days.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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vaccine group 1
vaccine produced by NVSI , Specification: GI.1 / GII.4 (low), 0.5ml / dose
Norovirus Bivalent (GI.1 / GII.4) Vaccine（low）
Norovirus Bivalent (GI.1 / GII.4) Vaccine（low）administered intramuscularly according to a 0, 28，（56） day vaccination schedule
vaccine group 2
vaccine produced by NVSI , Specification: GI.1 / GII.4 (middle), 0.5ml / dose
Norovirus Bivalent (GI.1 / GII.4) Vaccine（middle）
Norovirus Bivalent (GI.1 / GII.4) Vaccine（middle）administered intramuscularly according to a 0, 28，（56） day vaccination schedule
vaccine group 3
vaccine produced by NVSI , Specification: GI.1 / GII.4 (high), 0.5ml / dose
Norovirus Bivalent (GI.1 / GII.4) Vaccine（high）
Norovirus Bivalent (GI.1 / GII.4) Vaccine（high）administered intramuscularly according to a 0, 28，（56）day vaccination schedule
Normal saline
（0.5ml / dose）produced by NVSI
Normal saline
Normal saline administered intramuscularly according to a 0, 28 ，（56）day vaccination schedule
Aluminum adjuvant
（0.5ml / dose）produced by NVSI
Aluminum adjuvant
Aluminum adjuvant administered intramuscularly according to a 0, 28，（56） day vaccination schedule
Interventions
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Norovirus Bivalent (GI.1 / GII.4) Vaccine（low）
Norovirus Bivalent (GI.1 / GII.4) Vaccine（low）administered intramuscularly according to a 0, 28，（56） day vaccination schedule
Norovirus Bivalent (GI.1 / GII.4) Vaccine（middle）
Norovirus Bivalent (GI.1 / GII.4) Vaccine（middle）administered intramuscularly according to a 0, 28，（56） day vaccination schedule
Norovirus Bivalent (GI.1 / GII.4) Vaccine（high）
Norovirus Bivalent (GI.1 / GII.4) Vaccine（high）administered intramuscularly according to a 0, 28，（56）day vaccination schedule
Normal saline
Normal saline administered intramuscularly according to a 0, 28 ，（56）day vaccination schedule
Aluminum adjuvant
Aluminum adjuvant administered intramuscularly according to a 0, 28，（56） day vaccination schedule
Eligibility Criteria
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Inclusion Criteria
* Based on medical history and physical examination, determined by the researcher as healthy;
* Volunteer legal guardians or trustees have the ability to understand (non-illiterate) research procedures, sign informed consent voluntarily with informed consent, and be able to comply with the requirements of clinical research protocols;
* Female subjects of childbearing age were not pregnant at the time of enrollment (negative urine pregnancy test), were not breastfeeding, and had no birth plan within the first 3 months after enrollment; effective contraceptive measures were taken within 2 weeks before enrollment.
Exclusion Criteria
* Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc .;
* Have a history of epilepsy, convulsions or convulsions, or a family history of mental illness;
* Those who received immunoenhancement or inhibitor therapy within 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;
* No spleen or spleen function defect caused by any situation;
* Severe liver and kidney disease, drug-uncontrollable hypertension (systolic blood pressure\> 140mmHg, diastolic blood pressure\> 90mmHg), diabetic complications, malignant tumors, various acute diseases or chronic attacks of acute diseases;
* Have a history of chronic gastrointestinal diseases, diarrhea or other digestive system diseases, and have had 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; are allergic to any component of the test vaccine;
* Live attenuated vaccine within14 days; other vaccines received within 7 days;
* Participating in other clinical trials in the near future;
* The investigator judges other circumstances that are not suitable for participation in this clinical trial.
* Premature birth (delivery before the 37th week of pregnancy), low weight (birth \<2300g) infants under 24 months of age;
* History of salvage, birth apnea, or other causes of salvage, neurological damage, severe chronic disease (such as Down syndrome, sickle cell anemia, or neurological disorders) in children under 24 months of age.
6 Months
59 Years
ALL
Yes
Sponsors
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Lanzhou Institute of Biological Products Co., Ltd
INDUSTRY
Beijing Zhong Sheng Heng Yi Pharmaceutical Technology Co., Ltd.
UNKNOWN
Zhengzhou University
OTHER
National Vaccine and Serum Institute, China
INDUSTRY
Responsible Party
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Locations
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qixian Center for Disease Control and Prevention
Hebi, Henan, China
Countries
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Other Identifiers
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CXSL1700011-I
Identifier Type: -
Identifier Source: org_study_id
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