Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06177912
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-12
First Post:
2023-12-11
Brief Title:
A Clinical Study of the V116 Vaccine for Children and Teenagers V116-013
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Phase 3 Randomized Double-Blind Study to Evaluate the Safety Tolerability and Immunogenicity of V116 in Children and Adolescents With Increased Risk of Pneumococcal Disease
Status:
ACTIVE_NOT_RECRUITING
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:
STRIDE-13
Brief Summary:
The purpose of this study is to evaluate the safety tolerability and immunogenicity of V116 compared to PPSV23 in children 2 through 17 years of age Researchers want to learn if V116 is as good as or is better than the PPSV23 vaccine in terms of the antibody immune response V116 and PPSV23 will be studied in children and teenagers who have a higher risk of getting invasive pneumococcal disease IPD
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 |
|---|---|---|---|
| jRCT2031230559 | REGISTRY | jRCT | None |
| V116-013 | OTHER | None | None |