COVID-19 Vaccine in Healthy Children Ages 2-5 Years

STUDY BASICS

Are you the parent of a child aged 2-5 years? Your child may be able to participate in a research study to help find out if the Moderna COVID-19 vaccine is safe and effective in children under the age of 12. Enrolled participants will be in the study up to 14 months and will have up to 6 in-person visits. Compensation is provided. Participation is voluntary.

STUDY PURPOSE

Several COVID-19 vaccines have been widely used in people aged 12 and older using a special authorization called an Emergency Use Authorization granted by the United States Food and Drug Administration. No COVID-19 vaccines are currently authorized to be used in children younger than 12 years of age outside of a research study. The purpose of this research study is to find out if the Moderna COVID-19 vaccine is safe and effective for preventing COVID-19 in children under age 12.

COULD THIS STUDY BE RIGHT FOR YOUR CHILD?

• Ages 2-5 years
• Able and willing to undergo blood draws
• Willing to complete electronic symptom diaries

WHAT PARTICIPANTS CAN EXPECT

Study participation lasts up to 14 months and includes up to 6 clinic visits, 2 telemedicine visits, and 11 brief telephone calls. Eligible participants will be randomly assigned to receive two doses of the Moderna COVID-19 vaccine or two doses of placebo vaccine. The placebo vaccine looks like the Moderna vaccine but contains no active ingredients. The two doses will be administered about one month apart. If the FDA approves the COVID-19 vaccine for emergency use in children, as they have in adults, the study will be amended to allow those in the placebo group to receive it. Study procedures include physical exams, blood draws, nasal swabs, and completing an online symptom diary.