This trial is not actively recruiting.

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

A clinical trial for an investigational respiratory syncytial virus (RSV) vaccine combined with an approved flu vaccine for older adults.

Trial ID: mRNA-1345-P302
The RSVictory Trial is a clinical trial conducted by Moderna to determine whether an investigational vaccine, mRNA-1345, can protect people from RSV when given with an approved flu vaccine. RSV is a common cause of respiratory tract infection and may cause severe disease, especially in younger children and older adults.

Trial Details

The purpose of the RSVictory Trial is to assess the safety and immune response of an investigational vaccine, mRNA-1345, for RSV infection when given with or without an approved flu vaccine. RSV and the flu are both common respiratory viruses that infect the lungs and breathing passages. People most often associate RSV with the risk it brings to young children, but not many know the high risk it poses for older adults.

RSV symptoms can be like 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. RSV is an increasingly recognized cause of major illness among older adults and adults with certain health conditions, especially those with heart and lung disease. Currently there is no approved vaccine for RSV.

The flu is estimated to cause 3 to 5 million cases of severe illness and up to 650,000 deaths each year. Current flu vaccinations rarely exceed 60% overall effectiveness.

mRNA-1345 is an investigational vaccine, based on mRNA technology.

Estimated Enrollment

1,350 Participants

Phase

Phase 3

Eligibility Criteria

Participants must:

  • Be 50 years of age or older
  • Be in good health
  • Primarily responsible for self-care (does not require a caregiver)

Participants must not:

  • Have had close contact with someone who has tested positive for COVID-19 within 10 days prior to initial screening visit
  • Have received any vaccine in the past month, or plan to receive a month after clinical trial vaccination
  • Have received a seasonal flu shot in the past 6 months
  • Have participated in another trial in the past month

Site Locations

Sites are located in the cities/states identified with the red pin:

What to Expect

Participation in this clinical trial lasts up to 6 months and includes up to 5 in-person visits and 4 telephone calls with the clinical trial staff.

Participants will be randomly assigned to one of three groups. Each participant will get two injections, one in each upper arm.

  • Group 1 will receive the investigational mRNA vaccine and a placebo (sterile saline).
  • Group 2 will receive the investigational mRNA vaccine and an approved flu vaccine.
  • Group 3 will receive an approved flu vaccine and a placebo. Participants will be asked to attend in-person site visits including a Screening Visit, a Vaccination Visit, and up to four subsequent site visits (Day 8, Month 1, and Month 6).

Participants will be asked to have up to 4 phone calls with the clinical trial doctor to monitor any symptoms. During these phone calls, the doctor and medical staff will check how you are feeling and ask for updates on your health.

Participants will be asked to use an eDiary app on their personal smartphone or a provided smartphone to report any symptoms you experience.

Insurance is not needed to join this clinical trial, and travel expenses will be reimbursed.

Frequently Asked Questions (FAQs)