Efficacy and Safety of MK-1654 in Infants (MK-1654-004)

  • STATUS
    Recruiting
  • End date
    Jan 8, 2025
  • participants needed
    3300
  • sponsor
    Merck Sharp & Dohme Corp.
Updated on 23 July 2021
Investigator
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Primary Contact
Ageo Central General Hospital ( Site 3051) (2.4 mi away) Contact
+27 other location

Summary

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.

Details
Condition Respiratory syncytial virus infection, rsv infection
Treatment Placebo, MK-1654
Clinical Study IdentifierNCT04767373
SponsorMerck Sharp & Dohme Corp.
Last Modified on23 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is a healthy male or female who is an early or moderate pre-term infant (29 to 34 weeks and 6 days gestational age) or a late pre-term or full-term infant (35 weeks gestational age)
For the phase 2b cohort only: Has a chronological age >2 weeks of age up to 1 year and is entering the first RSV season at the time of obtaining documented informed consent
For the phase 3 cohort only: Has a chronological age from birth up to 1 year and is entering the first RSV season at the time of obtaining documented informed consent
For participants in South Korea only: Weighs 2 kg

Exclusion Criteria

Is recommended to receive palivizumab per local guidelines or professional society recommendations
Has known hypersensitivity to any component of MK-1654
Has a bleeding disorder contraindicating IM administration
Has had a recent illness with rectal temperature 100.5F (38.1C) or axillary temperature 100.0F (37.8C) within 72 hours predose
Has received any vaccine or monoclonal antibody for the prevention of RSV
Is currently participating in or has participated in an interventional clinical study with an investigational compound or device at any time before first dose administration or while participating in this study
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