National Foundation for Infectious Diseases

This trial is not actively recruiting.

This trial has completed recruitment on this platform, and is no longer accepting new referrals.

A Respiratory Syncytial Virus (RSV) vaccine study for children

A research study conducted by Moderna is testing an investigational vaccine that may protect people from RSV. RSV is a common cause of respiratory tract infection and may cause severe disease, especially in younger children and older adults.

Trial ID: NCT04528719-

Trial Details

The mRNA-1345-P101 study is evaluating the safety and immune response of an investigational vaccine, called mRNA-1345, to protect against RSV.

RSV can cause infections of the lungs and respiratory tract. Symptoms can be similar to a cold, and may include runny nose, sore throat, cough, and headache. However, RSV can lead to serious conditions like pneumonia especially for younger children and older adults. Currently there is not an approved vaccine for RSV.

Estimated Enrollment

40 Participants



Eligibility Criteria

Participants must:
  • Be between the ages of 12 and 59 months (1 – less than 5 years old)
  • Be in good health
  • Have received routine immunizations appropriate for their age
Participants must not:
  • Have participated in another trial in the past month
  • Have a history of epilepsy or febrile seizures

What to Expect

Participation in the mRNA-1345-P101 Study lasts approximately 16 months (or through the RSV season after the last vaccination) and includes phone calls and up to eleven visits to the study site.

  • Your child will be given three injections in the upper arm –the injections are approximately 56 days apart. Your child has a chance of receiving either the mRNA-1345 study vaccine or the placebo. By using a placebo, which has no impact on the body, medical researchers are able to understand if the study vaccine is effective in preventing RSV.
  • You and your child will have a mix of in-person and phone visits with the study doctor to monitor for any symptoms after injections. During these visits and phone calls, the study doctor and medical staff will check how your child is feeling and ask for updates on their health.
  • You will be asked to use an eDiary app on your smartphone or a provided smartphone to report any symptoms your child experiences.
  • Your child will be closely monitored by the study team if any symptoms or adverse events are reported at any time throughout their participation.

Insurance is not needed to join this clinical trial, and compensation for your time will be available.

You will need to bring your child to one of the study clinics taking part in this clinical trial.

Frequently Asked Questions (FAQs)