NCT04188691

A Clinical Trial to Evaluate the Safety and Immunogenicity of Norovirus Bivalent Vaccine

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 510 (actual)
• Sponsor: National Vaccine and Serum Institute, China · Industry
• Sex: All
• Age: 6 Months – 59 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Norwalk Gastroenteritis
• Norovirus Infections

Interventions

Type	Name	Description
BIOLOGICAL	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
BIOLOGICAL	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
BIOLOGICAL	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
BIOLOGICAL	Normal saline	Normal saline administered intramuscularly according to a 0, 28 ，（56）day vaccination schedule
BIOLOGICAL	Aluminum adjuvant	Aluminum adjuvant administered intramuscularly according to a 0, 28，（56） day vaccination schedule

Timeline

• Start date: 2019-11-28
• Primary completion: 2020-12-13
• Completion: 2020-12-13
• First posted: 2019-12-06
• Last updated: 2021-04-22

Locations

1 site across 1 country: China