Cytomegalovirus (CMV) is a leading cause of birth defects globally. Children born with congenital CMV infection are at risk of developing lifelong complications, such as hearing loss and developmental delays. There is an unmet need for safe and effective CMV prevention.
CMV is the #1 infection that causes birth defects in the U.S.
About the Clinical Trial
This Phase 3, randomized, placebo-controlled, observer-blind clinical trial is designed to evaluate the safety, efficacy, and immunogenicity of an investigational vaccine (mRNA-1647) for CMV in healthy volunteers.
In this approximately 30-month Phase 3 clinical trial, healthy women (ages 16-40) will be randomized 1:1 to receive the investigational vaccine or a placebo three times: at Day 1, Month 2, and Month 6. Participants will then be monitored over the following 24 months.
To enroll your patient in this clinical trial, they must be:
A woman between 16-40 years of age
In close contact with at least one child 5 years of age or younger for at least 8 hours a week, if age 20 or older
Not pregnant or planning on becoming pregnant within the next 9 months
There are additional eligibility criteria for participation. Clinical trial staff can help you confirm if your patient is eligible.
This vaccine uses a new technology platform utilizing messenger ribonucleic acid (mRNA). mRNA can induce cells to create viral antigens that mimic those of a natural CMV infection. The vaccine is given in the usual manner, as an injection into the upper arm.
This clinical trial is sponsored by Moderna. Moderna is committed to keeping people at the center of everything we do as we continue to explore what is possible through mRNA science.