A phase 2b/3 double-blind, randomised, placebo-controlled study to evaluate the efficacy and safety of MK-1654 in healthy pre-term and full-term infants
Open to recruitment
Aims of the study
This trial is testing an experimental drug called MK-1654 in infants. MK-1654 is being studied to see if it can prevent illnesses caused by respiratory syncytial virus (RSV).
Healthy infants up to 8 months and 29 days of age can be in this trial.
Why is this trial being done?
This trial is testing an experimental drug called MK-1654 in infants. MK-1654 is a type of antibody (called a “monoclonal antibody”) being studied to see if it can prevent illnesses caused by respiratory syncytial virus (RSV). An antibody is a protein naturally made in your child’s blood that helps their immune system fight illnesses like viral infections. A monoclonal antibody is a protein made in a lab that acts like a human antibody. Monoclonal antibodies that target RSV work by blocking RSV from entering the body’s cells.
What is RSV?
RSV is a common respiratory virus. It can cause cold-like symptoms, such as a runny nose, fever, and cough. Both adults and children can get RSV. Most healthy adults recover quickly from the virus. Sometimes, RSV causes serious health issues in infants, such as breathing problems, high fever, and infections of the lungs. RSV is one of the most common reasons that infants are taken to hospital and is the leading cause of hospitalisation and infant death under six months of age worldwide. It is estimated that over 30,000 infants under 5 are hospitalised every year in the UK because of RSV and 6% of these will need admission to intensive care. Most of these admissions occur in infants who are otherwise healthy. This trial will compare MK-1654 to placebo. A placebo looks like a trial drug, but it has no active ingredients.
What participating in the study involves
If you decide for your child to participate in this trial, you will be invited for a clinic visit. During this visit the trial doctor will check if it is safe, and if it is possible for your child to take part in this trial. If you take part in this trial, your child will visit the trial doctor about 7 times over 12 months or 8 times over 18 months, depending on when they start the trial. These trial visits will be in addition to any usual visits that you may make to your child’s own doctor. Most visits will last about 1 – 2 hours. There is a 1 in 3 chance of your child getting placebo. A placebo or “dummy” treatment looks like a trial drug, but it has no active ingredients. Your child’s GP will be informed if your child takes part in this trial. This is so they know which other medicines they may give your child safely.