This trial is not actively recruiting.

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

A clinical trial of an influenza vaccine for volunteers ages 18 and older

Trial ID: mRNA-1010-P301
A clinical trial conducted by Moderna is evaluating an investigational vaccine that may protect against seasonal influenza, commonly known as “the flu.” Seasonal flu is a common cause of sickness, severe illness, and even death.

Trial Details

The mRNA-1010-P301 clinical trial is evaluating the safety and immune response of an investigational vaccine that may protect against seasonal influenza (flu). The investigational mRNA-1010 vaccine is being compared to a currently available licensed flu vaccine. All participants will receive either the investigational mRNA-1010 vaccine or the currently available licensed flu vaccine.

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-1010 is an investigational flu vaccine, based on mRNA technology.

Estimated Enrolment

6,000 Participants

Phase

Phase 3

Eligibility Criteria

Participants must:

  • Be 18 years of age or older
  • Be in good health

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 in the next month
  • Have received a seasonal flu shot in the past 6 months
  • Have participated in another trial in the past 28 days

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 13 months and includes phone calls and visits to the trial site.

  • Participants will be given one injection in the upper arm. Participants will either receive the investigational vaccine, mRNA-1010, or a currently available licensed flu vaccine.
  • Participants will be asked to attend in-person site visits including a Screening Visit, a Vaccination Visit, and up to three subsequent site visits (Month 1, Month 6, and Month 12). There will also be an optional visit on Day 4, and additional visits may be scheduled.
  • Participants will be asked to have up to six phone calls with the clinical trial doctor to monitor for 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 a personal smartphone or a provided smartphone to report any symptoms you experience.
  • Participants will be closely monitored by the clinical trial team if any symptoms of influenza are reported at any time throughout their participation, and may be tested for influenza by nasal swab.

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

Frequently Asked Questions (FAQs)