Status: Open to Recruitment
Population: Paediatric
Disease group: CMV
Sponsor: ModernaTX, Inc.
Principal Investigator: Dr Simon Drysdale
Study Aims
Moderna is conducting a clinical trial, called the CMVibe Trial, on an investigational vaccine that may protect against cytomegalovirus (CMV). CMV is a common and often overlooked virus with lifelong impact. For most people, the symptoms of CMV, if there are any, can resemble the common cold with fatigue, headache, and sore throat. Once someone is infected with CMV, it stays latent or “sleeps” in the body for life. At certain times in a person’s life, such as pregnancy, CMV can reactivate. An active CMV infection during pregnancy puts the unborn baby at risk of birth defects. These include hearing loss, vision loss, or cerebral palsy, which can lead to long-term disability or, in severe cases, death.
The purpose of the CMVibe Trial is to see which dose level of the trial vaccine (called mRNA-1647) is most effective in people 9 to 15 years of age.
What does participating in the study involve?
This trial is enrolling volunteers 9 to 15 years of age and females 16 to 25 years of age. Participation in this trial lasts up to 18 months and includes up to 10 phone calls and 12 in-person visits to the trial site. Participants will receive 3 injections of mRNA-1647 over the first 6 months of the trial.
The Participant (and Parent, if the Participant is 9-15 years of age) will also be contacted through an electronic diary (eDiary) app (application) for 7 days following each trial vaccine injection.
For more information about the study, please visit:
Or contact the study team at:
- Find out more about the study on the Adult Participant Information Sheet
- Find out more about the study on the 9-11 years old Participant Information Sheet
- Find out more about the study on the 12-15 years old Participant Information Sheet
- Find out more about the study on the Guardian Consent Participant Information Sheet