Ignite Creation Date:
2024-07-17 @ 11:11 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06474377
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-06-19
Brief Title:
Phase I Clinical Trial of PCV24 in Adults
Sponsor:
Sinovac Life Sciences Co Ltd
Organization:
Sinovac Biotech Co Ltd
Study Overview
Official Title:
A Randomized Double-blind Controlled Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 24-valent Pneumococcal Conjugate Vaccine in Adults 18 Years of Age and Older
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
A Phase I clinical trial of 24-valent pneumococcal conjugate vaccine PCV24 developed by Sinovac Life Science Co Ltd will be conducted in adults aged 18 years and older The objective of the study is to evaluate the safety and immunogenicity of Sinovac PCV24 The trial is a randomized double-blind controlled Phase I clinical trial
Detailed Description:
A phase I clinical trial of the study of 24-valent Pneumococcal Polysaccharide Conjugate Vaccine PCV24 developed by Sinovac Life Science Co Ltd Sinovac will be conducted in Chinese adults aged 18 years and older The trial is a randomized double-blind and active controlled study The objective of this study is to evaluate the safety and immunogenicity of PCV24 manufactured by Sinovac Life Science Co Ltd The active control vaccine is the Pneumovax manufactured by MSD The placebo is 09NaCl solution
A total of at least 168 participants will be enrolled including 84 adults aged 18-59 years and 84 elderly people aged 60 years Participants will be randomized in a 2221 ratio to receive one dose of PCV24 formulation 1 PCV24 formulation 2 Pneumovax or placebo
A total of at least 168 participants will be enrolled including 84 adults aged 18-59 years and 84 elderly people aged 60 years Participants will be randomized in a 2221 ratio to receive one dose of PCV24 formulation 1 PCV24 formulation 2 Pneumovax or placebo
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