Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06151288
Status:
COMPLETED
Last Update Posted:
2024-01-30
First Post:
2023-11-10
Brief Title:
Safety Tolerability and Immunogenicity Study of a 31-Valent Pneumococcal Conjugate Vaccine VAX-31 in Adults
Sponsor:
Vaxcyte Inc
Organization:
Vaxcyte Inc
Study Overview
Official Title:
A Phase 12 Randomized Observer-Blind Dose-Finding Active-Controlled Parallel-Group Clinical Study to Evaluate the Safety Tolerability and Immunogenicity of a 31-Valent Pneumococcal Conjugate Vaccine VAX-31 in Healthy Adults Aged 50 Years and Older
Status:
COMPLETED
Status Verified Date:
2024-09
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 objective of the study is to evaluate the safety tolerability and immunogenicity of a single injection of VAX-31 at 3 dose levels compared to Prevnar 20 PCV20 in adults 50 to 64 years of age in Stage 1 Stage 2 will evaluate the safety tolerability and immunogenicity of a single injection of VAX-31 at 3 dose levels compared to PCV20 in adults aged 50 years and older
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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