Clinical Trial of Protective Efficacy of Quadrivalent Recombinant Norovirus Vaccine (Pichia Pastoris)
NCT Number: NCT06524947
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Acute Gastroenteropathy Due to Norovirus
Interventions: BIOLOGICAL: quadrivalent recombinant norovirus vaccine (Pichia pastoris)|BIOLOGICAL: quadrivalent recombinant norovirus vaccine (Pichia pastoris) placebo
Sponsor: Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Sex: ALL
Age: CHILD
Enrollment: 6600
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-07-27
Completion Date: 2027-03-28
Locations: Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention, Nanning, Guangxi, 530028, China|Hunan Center for Disease Control and Prevention, Changsha, Hunan, 410153, China|Sichuan Center for Disease Control and Prevention, Chengdu, Sichuan, 610041, China

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.

Primary Outcome Measures: Protective efficacy against AGE caused by four genotypes of norovirus, Protective efficacy against AGE caused by the four genotypes included in the prophylactic vaccine (GI.1, GII.3, GII.4, GII.17) (co-infections of rotavirus and adenovirus were excluded) after 7 days of full immunization until the end of the observation period.Protective efficacy = 1 - (person-years of incidence in the vaccine group/person-years of incidence in the placebo group) × 100%; person-years of incidence = (number of cases of AGE (excluding co-infections with rotavirus and adenovirus) caused by the four genotypes included in the vaccine (GI.1, GII.3, GII.4, and GII.17) after 7 days of 3 doses of the vaccine/number of person-years of observation) × 100%., From 7 days after full immunization to 2 years after 7 days after after full immunization|Geometric mean titers (GMT) of IgG antibody, Geometric mean titers of IgG antibodies against norovirus (GI.1, GII.3, GII.4, GII.17) were measured at 31 days after 2 doses, 31 days after full immunization, 180 days after full immunization, 1 year, and 2 years after full immunization., 31 days after 2 doses, 31 days after full immunization, 180 days after full immunization, 1 year, and 2 years after full immunization|Geometric mean titers (GMT) of HBGA blocking antibody, Geometric mean titers of HBGA blocking antibodies against norovirus (GI.1, GII.3, GII.4, GII.17) were measured at 31 days after 2 doses of immunization, 31 days after full immunization, 180 days after full immunization, 1 year, and 2 years after full immunization., at 31 days after 2 doses of immunization, 31 days after full immunization, 180 days after full immunization, 1 year, and 2 years after full immunization|Positive conversion rate of IgG antibodies, Positive conversion rate of IgG antibody against norovirus (GI.1, GII.3, GII.4, GII.17) at 31 days after 2 doses, 31 days after full immunization, 180 days after full immunization, 1 year and 2 years after full immunization., 31 days after 2 doses, 31 days after full immunization, 180 days after full immunization, 1 year and 2 years after full immunization|Positive conversion rate of HBGA blocking antibody, The positive conversion rate of HBGA blocking antibodies against norovirus (GI.1, GII.3, GII.4, GII.17) was measured at 31 days after 2 doses of immunization, 31 days after full immunization, 180 days after full immunization, 1 year, and 2 years after full immunization., 31 days after 2 doses of immunization, 31 days after full immunization, 180 days after full immunization, 1 year, and 2 years after full immunization|Geometric mean titers Growth multiplier of IgG antibody, Geometric mean titers Growth multiplier of IgG antibody at 31 days after 2 doses of immunization and at 31 days after full immunization., at 31 days after 2 doses of immunization and at 31 days after full immunization|Geometric mean titers Growth multiplier of HBGA blocking antibody, Geometric mean titers Growth multiplier of HBGA blocking antibody at 31 days after 2 doses of immunization and at 31 days after full immunization., at 31 days after 2 doses of immunization and at 31 days after full immunization|Occurrence of any adverse event, Occurrence of any adverse event within 30 minutes of each dose of vaccination., within 30 minutes of each dose of vaccination|Occurrence of recruited adverse event, Occurrence of recruited adverse event between day 0 and day 7 after each dose of vaccination., between day 0 and day 7 after each dose of vaccination|Occurrence of non-recruited adverse event, Occurrence of non-recruited adverse event between day 0 and day 30 after each dose of vaccination., between day 0 and day 30 after each dose of vaccination|Occurrence of serious adverse event, Occurrence of serious adverse event from the first dose to 180 days after full immunization., from the first dose to 180 days after full immunization