The ASSERVO study: Evaluating a potential medicine to prevent RSV in Healthy Pre-Term and Full-Term Infants

Primary Objective

The ASSERVO study is testing a potential medicine for infants to see if it may help prevent lower respiratory infections caused by respiratory syncytial virus, also known as RSV.

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Respiratory syncytial virus is a common respiratory virus. It can cause cold-like symptoms, such as a runny nose, fever, and cough. 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 the hospital. Currently, there are no approved treatments to prevent RSV for many infants. Your infant may be able to participate in this clinical research study if he/she: • Is 6 months old or younger • Is in good physical health There are additional eligibility criteria that the study doctor will explain to you.

Main Procedures Involved: If your infant is eligible and you agree to have your child participate, he/she will receive 1 dose of either the study medicine or placebo. The placebo looks like the study medicine but has no active medicine.

Duration of Participation: Your infant’s participation will continue for 12 or 17 months and include some follow-up visits and phone calls.




Childrens Hospital Colorado

Study ID

Protocol Number: 21-3387

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