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.
From January to April 2020, this study was affected by the COVID-19 epidemic, which caused the two groups(6-17-year-old,3-5-year-old) of subjects to vaccinate beyond the window and deviate from the experimental plan. After communication between the researcher, the sponsor and the statistician, it was decided to restart the Phase I clinical trials of these two groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
510
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
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
qixian Center for Disease Control and Prevention
Hebi, Henan, China
AE of local and systemic reactions within 30 minutes after each dose
Time frame: 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
Time frame: 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
Time frame: 28(30) days
All SAEs within 6 months after the last dose is vaccinated
Time frame: 6 months
Calculate geometric mean titer (GMT) of NoV GI.1 and GII.4 IgG antibodies
Time frame: 28 days after the full vaccination
Calculate positive rate of NoV GI.1 and GII.4 IgG antibodies
Time frame: 28 days after the full vaccination
Calculate NoV GI.1 and GII.4 HBGA-blocking antibody titers
Time frame: 28 days after the full vaccination
Calculate NoV GI.1 and GII.4 HBGA-blocking antibody positive rates
Time frame: 28 days after the full vaccination
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