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

NCT04941261 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1716

Last updated 2022-10-28

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Lanzhou Institute of Biological Products Co., Ltd

    collaborator INDUSTRY

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

    collaborator UNKNOWN

  • Zhengzhou University

    collaborator OTHER

  • 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
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-30
Primary Completion
2024-02-28
Completion
2024-03-30

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 NCT04941261 on ClinicalTrials.gov