Moderna

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 older adults

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 vaccination for RSV.

Estimated Enrollment

Study volunteers between the ages of 65-79 years, currently enrolling 300 participants

Phase

1

Eligibility Criteria

Participants must:
  • Be between 65 and 79 years old
  • Be in good health
Participants must not:
  • Have particiapated in another study in the past month
  • Have had cancer in the past 10 years (other than non-melanoma skin cancer or early stage cervical cancer)

What to Expect

Participation in the mRNA-1345-P101 study lasts approximately two years and includes phone calls, telemedicine visits, and up to fourteen visits to the study site.

  • You will be given two injections in the upper arm – the initial vaccination and a booster shot one year later. You have a chance of receiving either the mRNA-1345 study vaccine or the placebo. By using a placebo, medical researchers are able to understand if the study vaccine is effective in generating high levels of antibodies against RSV.
  • After each vaccination, you will be asked to return to the study site five to six times over the next year. You will have one telemedicine visit with the study doctor after each injection to monitor for any symptoms. During these phone calls, the study doctor and medical staff will check how you are feeling and ask for updates on your health.
  • You will be asked to use an eDiary app on your smartphone or a provided smartphone to report any symptoms you might experience 7 days after vaccination.
  • You will be closely monitored by the study clinic team if any symptoms are reported at any time throughout your participation.

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

Frequently Asked Questions (FAQ)