A clinical research study, also called a clinical trial, is a carefully designed scientific evaluation of an investigational medication or vaccine. Clinical research studies are conducted by doctors and researchers. A clinical research study helps to answer important questions about an investigational medication or vaccine, such as:

• How safe is it?
• Does it work?

All investigational medications and vaccines must be tested in clinical research studies before they can be approved by authorities to be prescribed to patients. Without people taking part in these studies, we would have no new medications.

There are always risks and benefits of participating in a clinical research study. There is always a chance that the investigational vaccine could cause side effects or won’t work. However, you should know that there are strict rules in place designed to ensure your safety. Before you join any clinical research study, you should consider the risks and ensure that you understand what they are. The study team will explain all of the risks and benefits at your first study visit. Throughout the study, you will be closely monitored by a team of local doctors and nurses. They will be there to answer any questions you may have.

If you are interested in participating, please fill out the form to see if you might be eligible for the study (you will be told immediately). If you are eligible, we will match you to a clinical research study center in your area that is participating in the study. We will also help you make your first study appointment at the study center. Please note that before being enrolled in the study, additional eligibility criteria will be checked by the study doctor or study team during the screening process.

The study-required investigational vaccine or placebo will be provided at no cost. Study-related care from a team of experienced doctors and nurses will also be provided throughout the study at no cost to you.

Participants are closely monitored, and their information will be carefully recorded and reviewed. All personal information will remain confidential, and participants’ names will not be included in any data reported.

Clinical research studies must undergo rigorous reviews and follow strict rules. These rules help to ensure that the rights, safety, and well-being of participants are at the forefront of any study.

Participating in a clinical research study comes with risks as well as benefits. Before you join a study, make sure you understand the possible benefits, such as getting access to study-related medical care and maybe helping others in the future, as well as the risks, such as known and/or unknown side effects. Take as much time as you need to decide whether to take part and get as much information as you can. Before joining a study, you will be asked to sign an informed consent form, which will include a full explanation of the study, including its potential risks.

It is up to you to decide if you want to take part in the RSV studies. Participation in a study is voluntary. Please also consider:

• If you decide you will participate, you can withdraw at any time during the study.
• The study team will explain the possible benefits and risks of the study during the informed consent process.
• You do not have to take part in any study if you don’t want to.
• A team of doctors and nurses will monitor your health carefully during the study.
• The investigational vaccine or placebo will be provided at no cost.
• If you will participate, you may be helping people with RSV in the future.

You will need to follow all the instructions from the study doctor and nurses.