Ignite Creation Date:
2024-05-06 @ 3:48 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04767373
Status:
COMPLETED
Last Update Posted:
2023-07-17
First Post:
2021-02-22
Brief Title:
Efficacy and Safety of Clesrovimab MK-1654 in Infants MK-1654-004
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Phase 2b3 Double-Blind Randomized Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-1654 in Healthy Pre-Term and Full-Term Infants
Status:
COMPLETED
Status Verified Date:
2024-07
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 primary objectives of this phase 2b3 double-blind randomized placebo-controlled study are to evaluate the efficacy and safety of clesrovimab in healthy pre-term and full-term infants It is hypothesized that clesrovimab will reduce the incidence of respiratory syncytial virus RSV-associated medically attended lower respiratory infection MALRI from Days 1 through 150 postdose compared to placebo
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 |
|---|---|---|---|
| MK-1654-004 | OTHER_GRANT | None | None |
| jRCT2051210019 | REGISTRY | None | None |
| PHRR210706-003684 | REGISTRY | None | None |
| 2022-500350-42-00 | REGISTRY | None | None |
| 2020-002405-26 | EUDRACT_NUMBER | EU CT Number | None |