Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06314685
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-03
First Post:
2024-03-11
Brief Title:
Immunogenicity and Safety of MCV4 in Volunteers Aged 6 Months-5 Years
Sponsor:
Beijing Zhifei Lvzhu Biopharmaceutical Co Ltd
Organization:
Beijing Zhifei Lvzhu Biopharmaceutical Co Ltd
Study Overview
Official Title:
A Single-center Randomized Blind Positive Control Phase III Clinical Trial to Evaluate Immunogenicity and Safety of Group ACYW135 Meningococcal Polysaccharide Conjugate Vaccine in Healthy Volunteers Aged From 6 Months to 5 Years
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
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 is to evaluate the immunogenicity and safety of Group ACYW135 Meningococcal Polysaccharide Conjugate Vaccine in healthy volunteers aged from 3 months to 5 years old
Detailed Description:
This is a Phase III single center randomized blind positive control clinical trial conducted in Hunan Province China The purpose of this study is to evaluate the immunogenicity and safety of Group ACYW135 Meningococcal Polysaccharide Conjugate Vaccine in healthy volunteers aged from 3 months to 5 years old A total of 2450 subjects were included divided into three age groups 6-11 months old 700 subjects 12-23 months old 1050 subjects and 2-5 years old 700 subjects
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