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

NCT06524947 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 6600

Last updated 2025-01-23

No results posted yet for this study

Summary

The purpose of the research is to evaluate the protective efficacy, immunogenicity, and safety of quadrivalent recombinant norovirus vaccine (Pichia Pastoris) in people aged 6 weeks to 13 years.A total of 6600 infants and children aged 6 weeks to 13 years old were enrolled in this study, which were divided into 3 age groups: 1400 children (6-13 years old), 2200 toddler (2-5 years old), and 3000 infants (6-23 months old).Subjects of all ages were randomly assigned to the test group and the control group in a 1:1 ratio.All subjects received 3 doses of the experimental vaccine at 30 day intervals.

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

Sponsors & Collaborators

  • Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • teng huang, master · Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Weeks
Max Age
13 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-27
Primary Completion
2027-03-28
Completion
2027-03-28

Countries

  • China

Study Locations

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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 NCT06524947 on ClinicalTrials.gov