Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06337071
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-29
First Post:
2024-03-13
Brief Title:
A Study of the ACYW135 Meningococcal Polysaccharide Conjugate Vaccine
Sponsor:
Aimei Vacin BioPharm Zhejiang Co Ltd
Organization:
Aimei Vacin BioPharm Zhejiang Co Ltd
Study Overview
Official Title:
A Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of the ACYW135 Meningococcal Polysaccharide Conjugate Vaccine in People Aged 3 Months to 15 Years Old in a Randomized Double-blind Parallel Controlled Design
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study was to explore the safety and immunogenicity of the experimental vaccine compared with the control vaccines It is planed to enroll a total of 1200 subjects including 300 subjects in each of the 3-5 months old 6-11 months old 12-23 months old and 2-15 years old groups who will be randomly assigned to the trial in a 11 ratio to study group or control group The 3-5 month-old group will have three doses vaccination at 0 1 and 2 month and a booster dose at 12 months of age the 6-11month-old and 12-23 month-old groups will each have total two doses vaccination the 2-15 year-old group will have one dose vaccination
Detailed Description:
The purpose of this study was to evaluate the safety and immunogenicity of the experimental vaccineACYW135 Meningococcal Polysaccharide Conjugate Vaccine compared with the control vaccinesACYW135 Meningococcal Polysaccharide Conjugate Vaccine and ACYW135 Meningococcal Polysaccharide Vaccine It is planed to enroll a total of 1200 subjects including 300 subjects in each of the 3-5 months old 6-11 months old 12-23 months old and 2-15 years old groups who will be randomly assigned to the trial in a 11 ratio to study group or control group The 3-5 month-old group will have three doses vaccination at 0 1 and 2 month and a booster dose at 12 months of age the 6-11month-old and 12-23 month-old groups will each have total two doses vaccinationat month 0 1 or at month 0 3 the 2-15 year-old group will have one dose vaccination The immunogenicity and immune persistence will be evaluated by rabbit complement serum bactericidal assay
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None