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About The Maternal Study

COVID-19 continues to spread around the world. One critical step in fighting this pandemic is learning about the safety and effectiveness of the vaccine for all expectant mothers and their babies. Expectant moms who make the important and personal decision to volunteer for this study will help us answer this question. By choosing to volunteer, you will represent expectant moms like you—in age, race, ethnicity, and from communities like yours. You can help make a difference for other expectant moms and babies.

This study involves comparing an investigational (study) vaccine against a placebo (injection with no active ingredient).  Participants who are given the placebo will have the opportunity to receive the study vaccine shortly after giving birth.  Your participation in the study will last about 7-10 months.

Who Can Participate
 

  • Healthy women over 18 years old who are pregnant and expecting one child
  • Participants should be about 24-34 weeks (6-8 months) pregnant when they receive the study injection
  • Participants should not have been previously diagnosed with COVID-19
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What to Expect

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A computer will randomly assign you to receive either the study vaccine or placebo. Neither you nor the study doctor will know if you are receiving the study vaccine or a placebo. One half of the study participants will receive the study vaccine, and the other half will receive the placebo.

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The first 2 visits are when you receive the study vaccine or placebo through an injection in your arm. These visits are about 3 weeks apart.

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After you receive your study injections, you will have 2 follow-up visits before your baby is born and 2 follow-up visits after your baby is born to monitor your health. Your baby will also have a follow-up visit when they are about 6 months old.

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One month after your baby is born, you will learn if you received the placebo or the active study vaccine (called unblinding) while you were pregnant. Participants who received the placebo will then have the opportunity to receive their first dose of the active study vaccine.

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Over the course of the study, you will need to track any side effects that you may have. To make this easier, you will be given an electronic diary (e-diary). If you prefer, you can also download a secure app on your smartphone.

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You will be reimbursed for expenses (such as parking, meals, travel) and time related to completing the e-diary.

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