Ignite Creation Date:
2024-05-06 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05731115
Status:
COMPLETED
Last Update Posted:
2023-09-18
First Post:
2023-02-07
Brief Title:
Lot-to-lot Consistency of 23-valent Pneumococcal Polysaccharide Vaccine
Sponsor:
Sinovac Biotech Co Ltd
Organization:
Sinovac Biotech Co Ltd
Study Overview
Official Title:
A Randomized Double-blind Clinical Trial to Evaluate the Lot Consistency Immunogenicity and Safety of 23-valent Pneumococcal Polysaccharide Vaccine in Adults Aged 40-65 Years
Status:
COMPLETED
Status Verified Date:
2023-02
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:
This study is a randomized double-blind phase Ⅳ clinical trial of 23-valent pneumococcal polysaccharide vaccine manufactured by Sinovac Biotech Co LtdThe purpose of this study is to evaluate the consistency of three consecutive lots immunogenicity and safety of 23-valent pneumococcal polysaccharide vaccine of commercial scale in participants aged 40-65 years
Detailed Description:
This study is a randomized double-blind phase Ⅳ clinical trial in subjects aged 40-65 years to evaluate the lot-to-lot consistencyimmunogenicity and safety of 23-valent pneumococcal polysaccharide vaccine of commercial scaleThe experimental vaccine was manufactured by Sinovac Biotech Co LtdA total of 1800 subjects will be enrolledThe subjects will be randomly divided into three groups in a ratio of 111 to received one dose of vaccine on day 0
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