Clinical Trial

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

Active, Not Recruiting Phase 3
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-07-23; most recent amendment 2025-01-22.
Status change: Recruiting → Active, Not Recruiting 2025-01-22
Status change: Not Yet Recruiting → Recruiting 2024-07-27
Trial Details
NCT Number NCT06524947
Lead Sponsor Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Conditions Acute Gastroenteropathy Due to Norovirus
Enrollment 6,600 participants
Start Date 2024-07-27
Primary Completion 2027-03-28 (estimated)
Study Completion 2027-03-28 (estimated)
Updated on ClinicalTrials.gov 2025-01-23