Trial Number
957-19
Condition
Respiratory Syncytial Virus (RSV)
Participant Age Range
pre-term and full-term infants
Participant Gender
Any
Enrolling Participants
Yes
Overview
“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”
The MK-1654-004 study is being conducted to assess the efficacy and safety, along with PK, of MK-1654 for the prevention of RSV-associated MALRI in healthy pre-term and full-term infants. The study will enroll participants with a chronological age up to 1 year and entering the first RSV season at the time of consent; infants 0 through 8 months (i.e., up to 8 months and 29 days) of age at the time of consent will comprise at least 90% of the participants.