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Study on the Safety and Effectiveness of MK-1654 for Preventing Respiratory Syncytial Virus (RSV) in Healthy Pre-Term and Full-Term Infants

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the prevention of Respiratory Syncytial Virus (RSV) in healthy infants. RSV is a common virus that can cause infections in the lungs and respiratory tract, particularly in young children. The study will test a treatment called MK-1654, developed by Merck & Co. Inc., to see how safe it is and how well it works in preventing RSV-related respiratory infections in infants. The trial will compare MK-1654 to a placebo to evaluate its effectiveness and safety.

The purpose of the study is to assess how well MK-1654 can prevent RSV-associated medically attended lower respiratory infections in both pre-term and full-term infants. The study will involve monitoring the infants from the time they receive the treatment up to 150 days afterward. During this period, researchers will observe the infants for any signs of RSV-related infections and any side effects that may occur.

Participants in the study will include healthy infants who are either early or moderate pre-term (born between 29 to 34 weeks and 6 days of gestational age) or late pre-term or full-term (born at 35 weeks or later). The study will also track any adverse events, such as fever or rash, to ensure the safety of the treatment. The ultimate goal is to determine if MK-1654 can effectively reduce the incidence of RSV-related infections in infants, providing a potential new option for preventing this common and sometimes serious virus.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the infant must meet specific criteria. The infant should be healthy and either an early or moderate pre-term infant (born between 29 to 34 weeks and 6 days of gestational age) or a late pre-term or full-term infant (born at or after 35 weeks of gestational age).

    For the phase 2b cohort, the infant should be older than 2 weeks and up to 1 year old, entering their first RSV season. For the phase 3 cohort, the infant should be from birth up to 1 year old, also entering their first RSV season.

  2. Step 2

    Receiving the medication

    The infant will receive either the study medication, MK-1654, or a placebo. The study is double-blind, meaning neither the caregivers nor the researchers know which treatment the infant receives.

    The medication is administered to evaluate its effectiveness in preventing RSV-associated lower respiratory infections and to assess its safety.

  3. Step 3

    Monitoring and follow-up

    The infant will be monitored for any signs of RSV-associated medically attended lower respiratory infections from day 1 through day 150 after receiving the dose.

    The study will also track any adverse events, such as injection-site reactions, fever, or other systemic reactions. Serious adverse events will be closely monitored.

  4. Step 4

    Completion of the study

    The study is expected to conclude by September 11, 2024. By this time, all data regarding the safety and efficacy of MK-1654 will be collected and analyzed.

    The results will help determine the potential of MK-1654 in preventing RSV infections in infants.

Who can join the trial?

5 criteria

  • The participant must be a healthy male or female.
  • The participant must be an early or moderate pre-term infant (born between 29 weeks and 34 weeks and 6 days of pregnancy) or a late pre-term or full-term infant (born at 35 weeks or more of pregnancy).
  • For the phase 2b group: The participant must be older than 2 weeks and up to 1 year old, and entering their first RSV season when consent is given.
  • For the phase 3 group: The participant must be from birth up to 1 year old, and entering their first RSV season when consent is given.
  • For participants in South Korea: The participant must weigh at least 2 kg (about 4.4 pounds).

Who cannot join the trial?

8 criteria

  • Participants cannot join if they have a history of severe allergic reactions to any ingredient in the study medication.
  • Individuals with a current or recent infection that requires treatment with antibiotics or antiviral medications are not eligible.
  • People with a known or suspected immune system disorder, which means their body's defense system is not working properly, cannot participate.
  • Participants who have received any vaccine within 30 days before the study starts are excluded.
  • Individuals who are currently participating in another clinical trial or have done so within the last 30 days cannot join.
  • Pregnant or breastfeeding women are not eligible to participate in the study.
  • Anyone with a history of drug or alcohol abuse within the past year is excluded.
  • Participants with any condition that the study doctors believe would make it unsafe for them to participate are not allowed to join.
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Investigated drugs

MK-1654 is a medication being studied to see if it can help prevent respiratory infections caused by a virus called respiratory syncytial virus (RSV) in infants. RSV is a common virus that can cause serious breathing problems, especially in young children. This medication is being tested to see if it can reduce the number of infants who need medical care for RSV-related breathing issues. The study also looks at how safe the medication is for infants and whether it causes any side effects. By participating in this trial, researchers hope to find out if MK-1654 can be a helpful treatment to protect infants from RSV infections.

What is already known about the treatment

MK-1654 – MK-1654 is administered as an injection and is currently being studied in clinical trials to prevent respiratory syncytial virus (RSV) infections in both pre-term and full-term infants. This medication is in the experimental phase and is not yet widely available in medical practice. It is designed to help protect infants from RSV, which can cause serious lung infections. MK-1654 works by targeting and neutralizing the virus, preventing it from causing illness. It is classified as an antiviral agent, specifically developed to combat RSV.

Investigated diseases

Respiratory Syncytial Virus Infection – Respiratory Syncytial Virus (RSV) infection is a common respiratory virus that usually causes mild, cold-like symptoms. It primarily affects the respiratory tract, including the nose, throat, and lungs. In some cases, especially in infants and older adults, it can lead to more severe respiratory illnesses such as bronchiolitis or pneumonia. The virus spreads through droplets from a cough or sneeze, or by touching surfaces contaminated with the virus. Symptoms typically appear 4 to 6 days after exposure and can include runny nose, decrease in appetite, coughing, sneezing, fever, and wheezing. The infection usually resolves within one to two weeks, but in severe cases, it may require medical attention.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IVTrial ID2022-500350-42-01Protocol codeMK-1654-004Estimated enrolment3 300 patientsSponsorMerck Sharp & Dohme LLC

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