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
Sponsor study identifier
interventional
510
1 country
1
Study Start
November 28, 2019
Actual (reported)Primary Completion
December 13, 2020
Actual (reported)Study Completion
December 13, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 13, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 27, 2019
Actual (reported)November 28, 2019
Actual (reported)December 6, 2019
Actual (reported)December 13, 2020
Actual (reported)December 13, 2020
Actual (reported)AE of local and systemic reactions within 30 minutes after each dose
30 minutes
All active AEs within 0-7 days after each dose
Active AE: Local and systemic adverse reactions occurring within 0-7 days after each dose of vaccination
7 days
All non-active collection AEs within 0-28（30） days after each dose
Adverse events other than active AE include solicitation adverse events reported in addition to the specified solicitation time window
28（30） days
All SAEs within 6 months after the last dose is vaccinated
6 months
Calculate geometric mean titer (GMT) of NoV GI.1 and GII.4 IgG antibodies
28 days after the full vaccination
Calculate positive rate of NoV GI.1 and GII.4 IgG antibodies
28 days after the full vaccination
Calculate NoV GI.1 and GII.4 HBGA-blocking antibody titers
28 days after the full vaccination
Calculate NoV GI.1 and GII.4 HBGA-blocking antibody positive rates
28 days after the full vaccination
vaccine produced by NVSI , Specification: GI.1 / GII.4 (low), 0.5ml / dose
vaccine produced by NVSI , Specification: GI.1 / GII.4 (middle), 0.5ml / dose
vaccine produced by NVSI , Specification: GI.1 / GII.4 (high), 0.5ml / dose
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）administered intramuscularly according to a 0, 28，（56） day vaccination schedule
qixian Center for Disease Control and Prevention
Hebi, Henan, China
510 participants (actual enrollment reported by the registry).
First Submitted
November 27, 2019
First Posted
December 6, 2019
Study Start
November 28, 2019
Actual (reported)（0.5ml / dose）produced by NVSI
（0.5ml / dose）produced by NVSI
Norovirus Bivalent (GI.1 / GII.4) Vaccine（high）administered intramuscularly according to a 0, 28，（56）day vaccination schedule
Normal saline administered intramuscularly according to a 0, 28 ，（56）day vaccination schedule
Aluminum adjuvant administered intramuscularly according to a 0, 28，（56） day vaccination schedule
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
December 13, 2020
Actual (reported)Study Completion
December 13, 2020
Actual (reported)Last Updated
April 22, 2021
Record last verified: 2020-04
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Source: ClinicalTrials.gov.
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