PROMISE (PROspective study of Maternal and Infant immunization, alone or in SEquence)

STUDY BASICS

Are you pregnant? You may be eligible for a research study that may help pregnant people in the future decide how they want to protect their babies from RSV. If you agree to take part in this study, your baby will also take part in this study when born. Compensation is provided.

STUDY PURPOSE

To prevent RSV in healthy infants, it is recommended that pregnant women receive an RSV vaccine during pregnancy or infants receive a RSV monoclonal antibody after birth, but not both. The purpose of this study is to better understand the safety and immune responses when both RSV prevention products are provided in combination to a pregnant person and their baby, compared to using either prevention product alone. The results from this study could help pregnant people in the future make choices about how they want to protect their babies from getting RSV.

COULD THIS STUDY BE RIGHT FOR YOU?

• 18-45 years of age
• Currently pregnant

WHAT PARTICIPANTS CAN EXPECT

You and your baby will be randomly selected to receive one of the RSV prevention products (maternal RSV vaccine or pediatric RSV monoclonal antibody), which is the current standard of care, or a combination of both products. 

In addition, 

• You will have about 7 in-person study visits
• Your baby will have about 5 study visits
• There will be 2 scheduled phone calls from the study team: one when your baby is about 1 month old and a second phone call when your baby is about 4 months old.