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

PHASE1CompletedINTERVENTIONAL
Enrollment

510

Participants

Timeline

Start Date

November 28, 2019

Primary Completion Date

December 13, 2020

Study Completion Date

December 13, 2020

Conditions
Norwalk GastroenteritisNorovirus 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

Trial Locations (1)

Unknown

qixian Center for Disease Control and Prevention, Hebi

All Listed Sponsors
collaborator

Lanzhou Institute of Biological Products Co., Ltd

INDUSTRY

collaborator

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

UNKNOWN

collaborator

Zhengzhou University

OTHER

lead

National Vaccine and Serum Institute, China

INDUSTRY

NCT04188691 - A Clinical Trial to Evaluate the Safety and Immunogenicity of Norovirus Bivalent Vaccine | Biotech Hunter | Biotech Hunter