Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06550830
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-08
Brief Title:
Phase Ia Clinical Trial of PCV24 in Children Aged 2-17 Years
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Double-blind Controlled Combined With Open-label Phase Ia Clinical Trial to Evaluate the Safety and Immunogenicity of 24-valent Pneumococcal Conjugate Vaccine in Children Aged 2-17 Years
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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 Ia clinical trial of 24-valent pneumococcal conjugate vaccine PCV24 developed by Sinovac Life Science Co Ltd will be conducted in children aged 2-17 years The objective of the study is to evaluate the safety and immunogenicity of Sinovac PCV24 The trial is a randomized double-blind controlled combined with open-label phase Ia clinical trial
Detailed Description:
A phase Ia clinical trial of the study of 24-valent Pneumococcal Conjugate Vaccine PCV24 developed by Sinovac Life Science Co Ltd Sinovac will be conducted in Chinese children aged 2-17 years The trial is a randomized double-blind controlled combined with open-label 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 for participants aged 2-5 years is the Prevenar13 manufactured by Pfizer
A total of at least 114 participants will be enrolled including 24 children aged 6-17 years and 90 children aged 2-5 years Children aged 6-17 years will receive PCV24 formulation 1 and PCV24 formulation 2 in a 11 ratio Children aged 2-5 years will receive PCV24 formulation 1 PCV24 formulation 2 and Prevenar13 in a 111 ratio
A total of at least 114 participants will be enrolled including 24 children aged 6-17 years and 90 children aged 2-5 years Children aged 6-17 years will receive PCV24 formulation 1 and PCV24 formulation 2 in a 11 ratio Children aged 2-5 years will receive PCV24 formulation 1 PCV24 formulation 2 and Prevenar13 in a 111 ratio
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