RSV-PR is an observational research study potentially open to any pregnant adult. It is designed to help us learn more about the ongoing health of pregnant individuals who received the RSV vaccine during the third trimester of pregnancy, as well as their infant after they’re born, compared to those who choose to not receive the vaccine. An observational study means participants agree to let researchers collect health facts, but treatment is not changed. Whether you receive the vaccine is entirely up to you. Both those who choose to get the RSV vaccine and those who choose to not be vaccinated may qualify for the study.

RSV (Respiratory Syncytial Virus) is a common cold-like virus that can be especially serious for infants.

The Centers for Disease Control (CDC) recommends pregnant individuals receive the RSV vaccine. The RSVpreF (Abrysvo) vaccine has been approved by the FDA for use during weeks 32-36 of pregnancy because studies have shown it to be safe and effective in preventing severe RSV for infants through 6 months of age. By receiving the vaccine, a pregnant individual can pass the protection on to their baby.

If you take part in RSV-PR, you will agree to share information specific to the RSV vaccination and about your and your baby’s health for the duration of your involvement in the study (until your infant is about 12 months old). This information will help us learn more about the health of individuals and their infants who have received an RSV vaccine during the third trimester of their current pregnancy.

We are asking individuals who are vaccinated against RSV during weeks 32-36 of pregnancy and those who choose not to be vaccinated to answer questions about their pregnancies, their health, and their babies’ health. This will be accomplished with online forms that take 5 to 10 minutes to fill out. We will also follow up with your doctors and your infant’s doctor to obtain additional information about your health and, if applicable, the vaccine’s effects.

RSV-PR will ask questions to you and your doctors about:

• Your background (such as your age and education level)
• Your pregnancy (such as your expected date of delivery, your weight at various time points and medications you are using)
• Your overall health (such as any pre-pregnancy medical conditions or pregnancy-related problems)
• Your RSV vaccination
• Your current health status
• Your labor and delivery (such as C-section or vaginal birth and length of labor)
• Your baby’s health (such as his or her growth and weight gain)

Researchers will examine the information from RSV-PR participants to identify trends, similarities, and differences and to answer research questions regarding vaccination against RSV during pregnancy.

A research study is a project that aims to learn more about a specific topic. In this case, we are hoping to learn more about the RSV vaccine and pregnancy.

Previous studies have enabled the FDA to approve, and the CDC to recommend, use of the RSV vaccine on pregnant individuals in weeks 32-36 to provide protection against RSV in infants through the first six months of life. It has proven to reduce the severity of RSV infection and reduce hospitalizations and deaths.

Many research studies collect information about health, medical care, or medical treatments. There are different types of research studies. RSV-PR is an observational study, meaning that it is only collecting information (observing the participants).

While you and your baby may not benefit directly from participation, by participating in RSV-PR you will be contributing to a body of knowledge that could help medical researchers advance medical science, particularly improving healthcare for pregnant individuals and their infants in the future.

For your time, you may be compensated up to $125 for completing study-related tasks.

There are no known physical risks of taking part in RSV-PR. But, like any online activity, there is always a risk of loss of privacy. For more details on privacy risks, please see the Consent Form or the Privacy Policy.

You may qualify if:

• You are at least 32 weeks pregnant at enrollment
• You are 18 to 50 years of age
• You are a United States resident
• You have not received an RSV vaccine before week 32 of pregnancy
• You are not pregnant with more than one fetus

RSV-PR is being conducted with financial support from Pfizer.

In general, only the RSV-PR Study Team and the website developers will see your personal information. These individuals are trained to protect patient privacy and keep data secure. RSV-PR will not share your name and other personal information with anyone else, except in specific situations noted in the Informed Consent Form.

In the database, we will replace your name with a code number to hide your identity in the data. Only qualified and approved scientists and researchers will have access to this "de-identified" or "coded" data, meaning they will not have access to your name or other personal information that could reveal your identity. They will study the de-identified information from RSV-PR to look for trends or common issues that many individuals, or certain groups of individuals, may experience. For instance, they might discover that 4,000 out of 10,000 RSV-PR participants reported having severe muscle pain shortly after the vaccination, but they won’t know who any of those individuals are. RSV-PR may also share de-identified information with other databases, registries, and data repositories. Combining RSV-PR data with other sources may help us expand our knowledge about pregnancy and could lead to new study ideas and future treatments.

RSV-PR follows strict rules to protect your privacy, including relevant federal laws and regulations. Generally, only the RSV-PR Study Team will know that you are part of RSV-PR and will have access to your information. However, there are exceptions to this situation listed in the Consent form (if you have already joined, a copy is available on the Dashboard). For additional information, please see the Privacy Policy and Disclaimers and Policies documents available through RSV-PR.

No. RSV-PR will not tell anyone that you, specifically, are part of the study.

RSV-PR will maintain all the information you provide in a safe, secure computer database that conforms with government security requirements, including the Federal Information Security Management Act of 2002 (FISMA, 44 U.S.C. § 3541).

The first step in securing your information is for you to use a password that is difficult for someone to guess and that you do not share with anyone. In addition, if you are accessing RSV-PR using a cell phone or other mobile device, having a passcode on your device will improve security of your data. Although we are using many tools and practices to ensure the security of information saved in RSV-PR, we cannot guarantee the security of data on your computer or mobile device. We also cannot guarantee the security of data while it is being sent to RSV-PR database from your computer or mobile device.

After RSV-PR ends, we will continue to keep the information you provided in a secure database, and your identity will remain protected. De-identified data—data without participants’ identities or any information that could reveal their identities—from RSV-PR will continue to be available for researchers to study for many years after the project ends. RSV-PR de-identified data may be requested by doctors, scientists, and other interested parties who want to do their own research on pregnancy and/or who want figure out how many RSV-PR participants may be eligible for other research studies.

Any adult who is pregnant and between 18 and 50 years of age and who can complete the consent form for themselves may be eligible. Selecting the appropriate prompts in the consent form constitutes an electronic signature of the form and signifies acceptance of the risks and benefits involved in RSV-PR.

If you have already joined RSV-PR, a copy of your signed Consent form is available on the Dashboard.

It is your decision to take part in RSV-PR. You can decide to stop participating at any time: just stop entering information. You do not need to provide a reason for stopping your participation.

To withdraw from RSV-PR, you can send an email to RSV-PR Study Team at RSV@corevitas.com. Please specify in your email whether you want to:

Stop answering RSV-PR questionnaires and stop receiving RSV-PR email reminders and other messages,

or

Remove all your information from the active database.

Please remember we cannot get back any of your data included in de-identified data shared before RSV-PR received and processed your request for removal.

Yes, you can! Please, click the button below.