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Norovirus Bivalent (GI.1 / GII.4) Vaccine(low)Wiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (7)


Name (Synonyms) Correlation
drug1650 Norovirus Bivalent (GI.1 / GII.4) Vaccine(middle) Wiki 1.00
drug2024 Random Donor Plasma Wiki 1.00
drug1648 Norovirus Bivalent (GI.1 / GII.4) Vaccine(high) Wiki 1.00
drug151 Aluminum adjuvant Wiki 1.00
drug652 Convalescent Plasma Transfusion Wiki 0.71
drug2381 Supportive Care Wiki 0.58
drug1645 Normal saline Wiki 0.45

Correlated MeSH Terms (2)


Name (Synonyms) Correlation
D005759 Gastroenteritis NIH 0.71
D017250 Caliciviridae Infections NIH 0.71

Correlated HPO Terms (0)


Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials


1 A Randomized, Blind, Placebo-controlled Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Norovirus Bivalent (GI. 1 / GII. 4) Vaccine (Hansenulapolymorpha) in Healthy People Aged 6 Months to 59 Years

A total of 450 subjects were enrolled, divided into four age groups, including 18-59 years, 6-17 years, 3-5 years, and 6-35 months. There are three types of the test vaccine component in each age group. A total of 30 people in each dose group were vaccinated with the test vaccine or placebo 1 or placebo 2, respectively, in a ratio of 3: 1: 1. 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.

NCT04188691 Norwalk Gastroenteritis Norovirus Infections Biological: Norovirus Bivalent (GI.1 / GII.4) Vaccine(low) Biological: Norovirus Bivalent (GI.1 / GII.4) Vaccine(middle) Biological: Norovirus Bivalent (GI.1 / GII.4) Vaccine(high) Biological: Normal saline Biological: Aluminum adjuvant
MeSH:Caliciviridae Infections Gastroenteritis

Primary Outcomes

Measure: AE of local and systemic reactions within 30 minutes after each dose

Time: 30 minutes

Description: Active AE: Local and systemic adverse reactions occurring within 0-7 days after each dose of vaccination

Measure: All active AEs within 0-7 days after each dose

Time: 7 days

Description: Adverse events other than active AE include solicitation adverse events reported in addition to the specified solicitation time window

Measure: All non-active collection AEs within 0-28(30) days after each dose

Time: 28(30) days

Measure: All SAEs within 6 months after the last dose is vaccinated

Time: 6 months

Secondary Outcomes

Measure: Calculate geometric mean titer (GMT) of NoV GI.1 and GII.4 IgG antibodies

Time: 28 days after the full vaccination

Measure: Calculate positive rate of NoV GI.1 and GII.4 IgG antibodies

Time: 28 days after the full vaccination

Measure: Calculate NoV GI.1 and GII.4 HBGA-blocking antibody titers

Time: 28 days after the full vaccination

Measure: Calculate NoV GI.1 and GII.4 HBGA-blocking antibody positive rates

Time: 28 days after the full vaccination


No related HPO nodes (Using clinical trials)