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

Norovirus Infections Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Gastroenteritis
• Norovirus Infections
• Norwalk Gastroenteritis

• NCT number: NCT04188691
• Study type: Interventional
• Source: National Vaccine and Serum Institute, China
• Status: Completed
• Phase: Phase 1
• Start date: November 28, 2019
• Completion date: December 13, 2020