Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06617715
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-26
Brief Title:
Phase Ⅲ Clinical Trial of 13-Valent Pneumococcal Conjugate Vaccine
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase Ⅲ Clinical Study to Evaluate the Safety and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine PCV13 in Healthy Infants
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A Phase Ⅲ clinical trial of 13-valent pneumococcal conjugate vaccine PCV13 developed by Sinovac Life Science Co Ltd will be conducted in pediatric population aged 2 months minimum 6 weeks-5 years before 6th birthday The objective of the study is to evaluate the immunogenicity and safety of Sinovac PCV13
Detailed Description:
A phase Ⅲ clinical trial of the study of 13-valent Pneumococcal Polysaccharide Conjugate Vaccine PCV13 developed by Sinovac Life Science Co Ltd Sinovac will be conducted in Chinese pediatric population aged 2 months minimum 6 weeks-5 years before the 6th birthday The trial is a randomized double-blind active controlled combined with open-labelled study The objective of this study is to evaluate the immunogenicity and safety of PCV13 manufactured by Sinovac Life Science Co Ltd The active control vaccine is Prevenar13 A total of at least 3975 participants aged 6 weeks to 5 years will be enrolled Participants will be randomized in 11 ratio to the test group or control group except for infants aged 3 months Infants aged 3 months will receive Sinovac PCV13
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None