Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06344065
Status:
RECRUITING
Last Update Posted:
2024-04-03
First Post:
2024-03-11
Brief Title:
Immunogenicity and Safety of Diphtheria Tetanus Pertussis DTaP Vaccine in 3-month-old Infants
Sponsor:
Beijing Zhifei Lvzhu Biopharmaceutical Co Ltd
Organization:
Beijing Zhifei Lvzhu Biopharmaceutical Co Ltd
Study Overview
Official Title:
A Phase III Single Center Randomized Blind and Positive Control Clinical Trial to Evaluate the Immunogenicity and Safety of Diphtheria Tetanus and Acellular Pertussis Component Combined Vaccine Adsorbed in 3-month-old Infants
Status:
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 safety and immunogenicity of the DTaP in 3-month-old infants
Detailed Description:
This is a Phase III Single Center Randomized Blind and Positive Control Clinical Trial conducted in Guangxi Province China The purpose of this study is to evaluate the safety and immunogenicity of Diphtheria Tetanus and Acellular Pertussis Component Combined Vaccine Adsorbed in 3-month-old infants Expected to include 1584 3-month-old infants Among them 1056 infants were randomly assigned to the experimental group and active control group 1 and 528 infants were included in active control group 2 Select the top 200 subjects with study numbers from the experimental group as immunological persistence follow-up subset
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