Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-01-01 @ 2:20 AM
Study NCT ID:
NCT06314867
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-04
First Post:
2024-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
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:
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 1:1:1, with 330 individuals in each group receiving three batches of experimental vaccines, respectively. All subjects were vaccinated with 1 dose of 0.5ml, 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?: