MK-1654 in Infants and Children at Increased Risk for Severe Respiratory Syncytial Virus (RSV) Disease (MK-1654-007)
MK-1654 in Infants and Children at Increased Risk for Severe Respiratory Syncytial Virus (RSV) Disease (MK-1654-007)
This study aims to evaluate the safety and tolerability of MK-1654 compared to palivizumab as assessed by the proportion of participants experiencing adverse events (AEs).
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: A Phase 3, Multicenter, Randomized, Partially Blinded, Palivizumab- Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of MK-1654 in Infants and Children at Increased Risk for Severe RSV Disease
Estimated Study Start Date: November 15, 2021
Estimated Primary Completion Date: August 21, 2025
Estimated Study Completion Date: April 27, 2026
Arm:
- Experimental: MK-1654
- Active Comparator: Palivizumab
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Actual enrolment | 321 |
| Actual Study start date | 24 September 2018 |
| Estimated Study Completion Date | 12 July 2022 |