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Clinical Trial of Protective Efficacy of Quadrivalent Recombinant Norovirus Vaccine (Pichia Pastoris)
Sponsor: Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
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
Conditions
Interventions
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
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