NCT06524947View on ClinicalTrials.gov

Clinical Trial of Protective Efficacy of Quadrivalent Recombinant Norovirus Vaccine (Pichia Pastoris)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

6,600

Participants

Timeline

Start Date

July 27, 2024

Primary Completion Date

March 28, 2027

Study Completion Date

March 28, 2027

Conditions
Acute Gastroenteropathy Due to Norovirus
Interventions
BIOLOGICAL

quadrivalent recombinant norovirus vaccine (Pichia pastoris)

"Subjects were given three doses of quadrivalent recombinant norovirus vaccine (Pichia pastoris) at a 30-day interval.~Main ingredients: recombinant ReNoV GI.1-VP1 protein, recombinant ReNoV GII.3-VP1 protein, recombinant ReNoVGII.4-VP1 protein, recombinant ReNoV GII.17-VP1 protein, aluminum hydroxide adjuvant, histidine, sodium chloride, tween 80, disodium phosphate, disodium hydrogen phosphate"

BIOLOGICAL

quadrivalent recombinant norovirus vaccine (Pichia pastoris) placebo

"Subjects were given three doses of quadrivalent recombinant norovirus vaccine (Pichia pastoris) placebo at a 30-day interval.~Main ingredients: aluminum hydroxide adjuvant, histidine, sodium chloride, tween 80, disodium phosphate, disodium hydrogen phosphate"

Trial Locations (3)

410153

Hunan Center for Disease Control and Prevention, Changsha

530028

Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention, Nanning

610041

Sichuan Center for Disease Control and Prevention, Chengdu

All Listed Sponsors
lead

Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.

INDUSTRY

NCT06524947 - Clinical Trial of Protective Efficacy of Quadrivalent Recombinant Norovirus Vaccine (Pichia Pastoris) | Biotech Hunter | Biotech Hunter