Effectiveness and safety of a Merck RSV preventation drug in healthy pre-term and full-term infants
Participants needed: Infants under 12 months old
What is the purpose of the study?
This study will try to find out if the study drug MK-1654 is safe and effective in protecting infants against a germ called RSV (respiratory syncytial virus).
RSV is a germ that can cause airway infections. Most RSV infections just result in symptoms similar to a simple cold (such as a runny nose, sneezing and cough). However, RSV infection can be more serious in young babies, whose airways are still very small and whose immune system cannot fight germs very well. RSV is the most common cause of bronchiolitis (infection of the breathing tubes) and some pneumonia (lung infection) in young infants. Severe RSV in young babies can cause wheezing and asthma in childhood.
Your child’s body can fight off most germs. Often it takes a while to fight off a germ after coming into contact with it. During that time the germ can make your child sick. The study drug, MK-1654, is called a monoclonal antibody, which works by imitating the body’s natural immune response until it can do so safely on its own.
Unfortunately, there are no vaccines available to protect babies and children against RSV and the only two approved drugs (palivizumab and ribavirin) are used only for babies with poor immune systems at high risk of getting seriously sick. Therefore, Merck is developing this new RSV drug to protect infants from RSV disease, including bronchiolitis and pneumonia.
Who is eligible?
Your child can take part in this study if:
1. S/he is healthy and between birth and 12 months of age (Phase 3)
2. If a pre-term baby born no earlier than 29 weeks gestation
3. S/he has not received any other mAb (monoclonal antibody) or vaccine, including vaccination of the mum for RSV during pregnancy.
What would I be expected to do?
Children participating in the study will receive either the RSV drug, MK-1654, or placebo. A placebo looks like the study drug, but is a sterile, inactive, saline (salt water) solution – it has no active ingredients.
If your child joins the study, a computer will randomly place your child into 1 of 2 study groups to receive either the study drug or placebo. Once assigned to a group your child will receive one injection in the thigh on Day 1 of the study and be followed with weekly phone calls for either 18 months (first 1,650 participants) or 12 months (last 1,650 participants). Your child will have 7 scheduled study visits over a one-year period, or 8 visits over an 18-month period depending on when you start taking part in the study. You will also receive several telephone calls; the first on Day 3, then weekly for the first 6 months of the study, followed by one more follow-up call between Visits 6 and 7 (around 300 day, so towards the end of the year).
Your child may also need to be seen by study staff when s/he has a cough, a runny nose, a blocked nose, difficulty in breathing, or wheezing (unscheduled study visit). These are symptoms of a respiratory infection and could be due to RSV. It is important to contact us if your child has respiratory symptoms.
Contact Aimee Gonzalez de Armas