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ACTIVE NOT RECRUITING
NCT06524947
PHASE3

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

Sponsor: Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: Phase III Clinical Trial to Evaluate the Protective Efficacy, Immunogenicity, and Safety of Quadrivalent Recombinant Norovirus Vaccine (Pichia Pastoris) Implanted in People Aged 6 Weeks to 13 Years

Key Details

Gender

All

Age Range

6 Weeks - 13 Years

Study Type

INTERVENTIONAL

Enrollment

6600

Start Date

2024-07-27

Completion Date

2027-03-28

Last Updated

2025-01-23

Healthy Volunteers

Yes

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

Locations (3)

Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention

Nanning, Guangxi, China

Hunan Center for Disease Control and Prevention

Changsha, Hunan, China

Sichuan Center for Disease Control and Prevention

Chengdu, Sichuan, China