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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: July 10, 2024

Interventions

  • Biological: MK-1654
    • MK-1654 solution
  • Drug: Placebo
    • Placebo (0.9% sodium chloride [NaCL]) solution

Arms, Groups and Cohorts

  • Experimental: MK-1654
    • Participants receive a single intramuscular (IM) administration of MK-1654 on Day 1.
  • Placebo Comparator: Placebo
    • Participants receive a single IM administration of placebo on Day 1.

Clinical Trial Outcome Measures

Primary Measures

  • Percentage of participants with RSV-associated MALRI
    • Time Frame: From Day 1 (postdose) to Day 150
    • Outpatient and inpatient MALRI is defined as the presence of the following in a clinical setting: 1) cough or difficulty breathing; AND 2) 1 or more of wheezing, chest wall in-drawing/retraction, rales/crackles, hypoxemia, tachypnea, or dehydration; AND 3) RSV-positive reverse transcriptase polymerase chain reaction (RT-PCR) nasopharyngeal sample.
  • Percentage of participants with solicited injection-site adverse events (AEs)
    • Time Frame: From Day 1 (postdose) to Day 5
    • An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with solicited injection-site AEs (i.e., redness/erythema, swelling, and pain/tenderness) will be reported.
  • Percentage of participants with fever
    • Time Frame: From Day 1 (postdose) to Day 5
    • Fever is defined as as rectal temperature ≥102.2°F (≥39.0°C) or axillary temperature ≥101.7°F (≥38.7°C). The percentage of participants with fever will be reported.
  • Percentage of participants with solicited systemic AEs
    • Time Frame: From Day 1 (postdose) to Day 5
    • An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with solicited systemic AEs (i.e., irritability, drowsiness, and appetite lost) will be reported.
  • Percentage of participants with anaphylaxis/hypersensitivity AE of special interest (AESI)
    • Time Frame: From Day 1 (postdose) to Day 42
    • An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with anaphylaxis/hypersensitivity will be reported.
  • Percentage of participants with rash AESI
    • Time Frame: From Day 1 (postdose) to Day 42
    • An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with rash will be reported.
  • Percentage of participants with ≥1 nonserious AE
    • Time Frame: From Day 1 (postdose) to Day 42
    • An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
  • Percentage of participants with serious adverse events (SAEs)
    • Time Frame: Up to Day 515
    • An SAE is any untoward medical occurrence that results in death; is life-threatening; required inpatient hospitalization/prolongs existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or other important medical event. The percentage of participants with SAEs will be reported.

Secondary Measures

  • Percentage of participants with RSV-associated hospitalization
    • Time Frame: From Day 1 (postdose) to Day 150
    • RSV-associated hospitalization is defined as a hospital admission for respiratory illness AND RSV-positive RT-PCR nasopharyngeal sample.
  • Percentage of participants with RSV-associated MALRI
    • Time Frame: From Day 1 (postdose) to Day 180
    • Outpatient and inpatient MALRI is defined as the presence of the following in a clinical setting: 1) cough or difficulty breathing; AND 2) 1 or more of wheezing, chest wall in-drawing/retraction, rales/crackles, hypoxemia, tachypnea, or dehydration; AND 3) RSV-positive RT-PCR nasopharyngeal sample.

Participating in This Clinical Trial

Key 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) – 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 (Phase 2b 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 (Phase 3 cohort only) Key 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 ≥100.5°F (≥38.1°C) or axillary temperature ≥100.0°F (≥37.8°C) 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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 1 Year

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Merck Sharp & Dohme Corp.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Medical Director, Study Director, Merck Sharp & Dohme Corp.

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