Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06524947
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-19
Brief Title:
Clinical Trial of Protective Efficacy of Quadrivalent Recombinant Norovirus Vaccine Pichia Pastoris
Sponsor:
None
Organization:
None
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 yearsA 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 oldSubjects of all ages were randomly assigned to the test group and the control group in a 11 ratioAll subjects received 3 doses of the experimental vaccine at 30 day intervals
Detailed Description:
Overall design A multicenter randomized double-blind placebo-controlled trial was designed
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 yearsA 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 oldSubjects of all ages were randomly assigned to the test group and the control group in a 11 ratioAll subjects received 3 doses of the experimental vaccine at 30 day intervals
Protective effectiveness evaluationAll subjects entered the observation period 7 days after completing the first dose of immunization Stool andor vomit samples if applicable from all AGE cases occurring during the observation period were collected and AGE caused by Norovirus was identified by PCRPrimary protective efficacy was calculated using data from primary endpoint cases that occurred between 7 days after completion of full immunization and the end of the observation period
Immunogenicity evaluationFor the immunogenic subgroup of subjects 120 subjects before the study number of each age group in a clinical trial site a total of 360 subjects blood samples were collected before the first dose of immunization 31 days after the second dose of immunization 31 days 180 days 1 year and 2 years after the total immunization and blood samples were 2530ml each timeIt is used to detect anti-norovirus IgG antibody tissue Blood group antigen HBGA blocking antibody and to detect the immunogenicity of anti-norovirus
Safety evaluationAdverse events AE and serious adverse events SAE All enrolled subjects collected AE 30 minutes after each dose of vaccine enlisted AE 0-7 days non-enlisted AE 0-30 days and SAE from the first dose to 180 days after full immunization
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 yearsA 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 oldSubjects of all ages were randomly assigned to the test group and the control group in a 11 ratioAll subjects received 3 doses of the experimental vaccine at 30 day intervals
Protective effectiveness evaluationAll subjects entered the observation period 7 days after completing the first dose of immunization Stool andor vomit samples if applicable from all AGE cases occurring during the observation period were collected and AGE caused by Norovirus was identified by PCRPrimary protective efficacy was calculated using data from primary endpoint cases that occurred between 7 days after completion of full immunization and the end of the observation period
Immunogenicity evaluationFor the immunogenic subgroup of subjects 120 subjects before the study number of each age group in a clinical trial site a total of 360 subjects blood samples were collected before the first dose of immunization 31 days after the second dose of immunization 31 days 180 days 1 year and 2 years after the total immunization and blood samples were 2530ml each timeIt is used to detect anti-norovirus IgG antibody tissue Blood group antigen HBGA blocking antibody and to detect the immunogenicity of anti-norovirus
Safety evaluationAdverse events AE and serious adverse events SAE All enrolled subjects collected AE 30 minutes after each dose of vaccine enlisted AE 0-7 days non-enlisted AE 0-30 days and SAE from the first dose to 180 days after full immunization
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None