A clinical trial for an investigational respiratory syncytial virus (RSV) vaccine combined with an investigational COVID-19 booster 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 investigational COVID-19 booster 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 investigational COVID-19 booster vaccine, called mRNA-1273.214. RSV and COVID-19 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. Being able to offer vaccines for both RSV and COVID-19 would allow for fewer medical appointments and greater convenience, especially for at-risk populations.

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 World Health Organization declared COVID-19 a pandemic in March 2020. Since that time, there have been more than 500 million cases and 6.2 million deaths worldwide. mRNA-1273.214 is an investigational COVID-19 booster vaccine, formulated to include potential protection against the Omicron variant.

Estimated Enrollment

1,680 Participants

Phase

Phase 3

Eligibility Criteria

Participants must:

  • Be 50 years of age or older
  • Be in good health
  • Be fully vaccinated against COVID-19
  • 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 tested positive for COVID-19 within the past 90 days
  • Have received any vaccine in the past month, or plan to receive a month after clinical trial vaccination

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Site Locations

Participants will need to go to one of the clinics taking part in this clinical trial. Participating clinics are located in:

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

What to Expect

Participation in this clinical trial lasts up to 7 months and includes up to 8 in-person visits and up to 5 telephone calls with the clinical trial staff.

Participants will be randomly assigned to 1 of 3 groups. Each participant will receive 2 injections, 1 in each upper arm.

  • Group 1 will receive the investigational RSV vaccine and a placebo (sterile saline).
  • Group 2 will receive the investigational RSV vaccine and the investigational COVID-19 booster.
  • Group 3 will receive the investigational COVID-19 booster and a placebo.

Participants will be asked to attend in-person site visits including a Screening Visit, a Vaccination Visit, and up to 6 subsequent in-person site visits. Some of these site visits may instead be phone calls.

Participants will be asked to have up to 5 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.

Check Eligibility

We'll check to see if you are eligible by asking you some questions.

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Frequently Asked Questions (FAQs)