NCT04941261

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

Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Recombinant Norovirus Bivalent (GI. 1 / GII. 4) Vaccine(Hansenula Polymorpha) in Healthy People Aged Aged From 6 Months to 59 Years

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,716 (estimated)
• Sponsor: National Vaccine and Serum Institute, China · Industry
• Sex: All
• Age: 6 Months – 59 Years
• Healthy volunteers: Accepted

Summary

Phase II clinical study will explore dose and safety, immunogenicity in 4 age groups, including 18-59 years old group, 6-17 years old group, 3-5 years old group, 6-35 months old group, with a total of 1716 subjects.

Conditions

• Norovirus Infections
• Norwalk Gastroenteritis

Interventions

Type	Name	Description
BIOLOGICAL	middle-dose Norovirus Bivalent (GI.1 / GII.4) Vaccine	Intramuscular injection of middle-dose Norovirus Bivalent (GI.1 / GII.4) Vaccine in the deltoid muscle of the upper arm
BIOLOGICAL	high-dose Norovirus Bivalent (GI.1 / GII.4) Vaccine	Intramuscular injection of high-dose Norovirus Bivalent (GI.1 / GII.4) Vaccine 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: 2021-06-30
• Primary completion: 2024-02-28
• Completion: 2024-03-30
• First posted: 2021-06-28
• Last updated: 2022-10-28

Locations

1 site across 1 country: China