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

NCT05916326 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 8000

Last updated 2026-01-16

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Lanzhou Institute of Biological Products Co., Ltd

    collaborator INDUSTRY

  • 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
13 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-06-30
Primary Completion
2025-07-27
Completion
2025-07-27

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT05916326 on ClinicalTrials.gov