Ignite Creation Date:
2024-05-06 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05696080
Status:
COMPLETED
Last Update Posted:
2024-02-28
First Post:
2023-01-13
Brief Title:
Safety and Immunogenicity of V116 in Adults With Increased Risk for Pneumococcal Disease V116-008
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Phase 3 Randomized Double-blind Active Comparator-controlled Clinical Study to Evaluate the Safety Tolerability and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults 18 to 64 Years of Age With Increased Risk for Pneumococcal Disease
Status:
COMPLETED
Status Verified Date:
2024-02
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:
STRIDE-8
Brief Summary:
The primary objectives of this study are to evaluate the safety and tolerability of the pneumococcal 21 valent conjugate vaccine V116 and to evaluate the serotype-specific opsonophagocytic activity OPA post-vaccination with V116 and PCV15 a pneumococcal conjugate vaccine that includes 15 serotypes PPSV23 comprised of the polysaccharides from 23 of the serotypes causing disease in adults post-vaccination within each vaccination group separately
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| V116-008 | OTHER | None | None |
| jRCT2061220106 | REGISTRY | jRCT | None |