NCT05916326

Phase III Clinical Trial to Evaluate the Human Norovirus Bivalent (GⅠ.1/GⅡ.4)Vaccine，Recombinant (Hansenula Polymorpha)

A Phase III Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Protective Efficacy, Safety and Immunogenicity of Human Norovirus Bivalent (GⅠ.1/GⅡ.4)Vaccine，Recombinant (Hansenula Polymorpha) in Healthy People Aged 6 Months to 13 Years

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 8,000 (actual)
• Sponsor: National Vaccine and Serum Institute, China · Industry
• Sex: All
• Age: 6 Months – 13 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the Efficacy, Safety and Immunogenicity of the Human Norovirus Bivalent (GⅠ.1/GⅡ.4)Vaccine，Recombinant (Hansenula polymorpha) in Healthy People Aged 6 Months to 13 Years After Vaccination

Conditions

• Norovirus Infections
• Norwalk Gastroenteritis

Interventions

Type	Name	Description
BIOLOGICAL	Human Norovirus Bivalent (GⅠ.1/GⅡ.4)Vaccine，Recombinant (Hansenula polymorpha)	Intramuscular injection of Human Norovirus Bivalent (GⅠ.1/GⅡ.4)Vaccine，Recombinant (Hansenula polymorpha) in the deltoid muscle of the upper arm
BIOLOGICAL	placebo	Intramuscular injection of placebo in the deltoid muscle of the upper arm

Timeline

• Start date: 2023-06-30
• Primary completion: 2025-07-27
• Completion: 2025-07-27
• First posted: 2023-06-23
• Last updated: 2026-01-16

Locations

3 sites across 1 country: China