Efficacy and Safety of MK-1654 in Infants (MK-1654-004)
Efficacy and Safety of MK-1654 in Infants (MK-1654-004)
The primary objectives of this phase 2b/3 double-blind, randomized, placebo-controlled study are to evaluate the efficacy and safety of MK-1654 in healthy pre-term and full-term infants. It is hypothesized that MK-1654 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.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 3300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Phase 2b/3 Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-1654 in Healthy Pre-Term and Full-Term Infants
Actual Study Start Date: April 7, 2021
Estimated Primary Completion Date: July 10, 2024
Estimated Study Completion Date: January 8, 2025
Arm:
- Experimental: MK-1654
- Placebo Comparator: Placebo
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 3300 |
| Actual Study start date | 07 April 2021 |
| Estimated Study Completion Date | 08 January 2025 |