Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06314867
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-04
First Post:
2024-03-11
Brief Title:
Clinical Study on Lot-to-lot Consistency and Immune Persistence of Three Commercial Batches of PPSV23
Sponsor:
Beijing Zhifei Lvzhu Biopharmaceutical Co Ltd
Organization:
Beijing Zhifei Lvzhu Biopharmaceutical Co Ltd
Study Overview
Official Title:
A Single Center Randomized Double-blind and Intergroup Control Clinical Study to Evaluation on Lot-to-lot Consistency and Immune Persistence of Three Commercial Batches of 23 Valent Pneumococcal Polysaccharide Vaccine
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 research objective is to evaluate lot-to-lot consistency and immune persistence of three commercial batches of 23 valent pneumococcal polysaccharide vaccine
Detailed Description:
This study adopted a randomized double-blind equivalency design with different batches of experimental vaccine 990 individuals aged 18-59 were included and divided into three groups at a ratio of 111 with 330 individuals in each group receiving three batches of experimental vaccines respectively All subjects were vaccinated with 1 dose of 05ml intramuscularly injected into the lateral deltoid muscle of the upper arm
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