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

NCT04188691 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 510

Last updated 2021-04-22

No results posted yet for this study

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.

Conditions

  • Norwalk Gastroenteritis
  • Norovirus Infections

Interventions

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

Sponsors & Collaborators

  • Lanzhou Institute of Biological Products Co., Ltd

    collaborator INDUSTRY

  • Beijing Zhong Sheng Heng Yi Pharmaceutical Technology Co., Ltd.

    collaborator UNKNOWN

  • Zhengzhou University

    collaborator OTHER

  • National Vaccine and Serum Institute, China

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-28
Primary Completion
2020-12-13
Completion
2020-12-13

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04188691 on ClinicalTrials.gov