A Study of mRNA-1010 Seasonal Influenza Vaccine in Adults 50 Years Old and Older

Completed · Phase 3

Conditions studied: Seasonal Influenza

In brief

The purpose of this study is to evaluate the safety and efficacy of mRNA-1010 in preventing seasonal influenza in adults 50 years and older.

Key facts

Study ID

NCT05566639

Run by

ModernaTX, Inc.

People needed

22502

Starts

2022-09-14

Expected to finish

2024-01-05

Last updated by the study team

2025-01-16

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Investigator has assessed that the participant understands and is willing and physically able to comply with protocol mandated follow-up, including all procedures.
• For female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first dose on Day 1, and agreement to continue adequate contraception through 90 days following vaccine administration.

You may not qualify if…

• Participant has had close contact with someone with laboratory-confirmed influenza infection or with someone who has been treated with antiviral therapies for influenza (for example, Tamiflu®) within the past 5 days prior to the Screening visit.
• Participant has had close contact to someone with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection or COVID-19 as defined by the US CDC or has had a positive SARS-CoV-2 test in the past 10 days prior to the Screening visit.
• Participant is acutely ill or febrile (temperature ≥38.0℃elcius [100.4°Fahrenheit]) 72 hours prior to or at the Screening visit or Day 1. Participants meeting this criterion may be rescheduled within the 28-day screening window.
• Participant has a history of a diagnosis or condition that, in the judgment of the investigator, is clinically unstable or may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures.
• Reported history of congenital or acquired immunodeficiency, immunocompromising/ immunosuppressive condition, asplenia, or recurrent severe infections.
• Reported history of anaphylaxis or severe hypersensitivity reaction after receipt of any mRNA or influenza vaccines or any components of the mRNA or influenza vaccines, including egg protein.
• Participant has received systemic immunosuppressant drugs for >14 days in total within 180 days prior to the Screening visit (for glucocorticosteroids, ≥10 milligrams (mg)/day of prednisone or equivalent) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the study. Inhaled, nasal, and topical steroids are allowed.
• Participant has received any vaccine authorized or approved by local health agency ≤28 days prior to study intervention (Day 1) or plans to receive a vaccine authorized or approved by local health agency within 28 days before or after the study intervention.
• Participant is unaware whether they have received an influenza vaccine in the previous influenza season.
• Participant received a seasonal influenza vaccine or any other investigational influenza vaccine within 180 days prior to Day 1
• Participant has tested positive for influenza by local health authority-approved testing methods within 180 days prior to Day 1.
• Participant has donated ≥450 milliliters (mL) of blood products within 28 days prior to the Screening visit or plans to donate blood products during the study.
• Note: Other inclusion and exclusion criteria may apply.

Where it is running

• Aarhus Universitetshospital — Århus N, Denmark
• Odense University Hospital — Odense, Denmark
• North Alabama Research Center, LLC — Athens, Alabama, United States
• Lenzmeier Family Medicine — Glendale, Arizona, United States
• Fiel Family and Sports Medicine/CCT Research — Tempe, Arizona, United States
• Noble Clinical Research — Tucson, Arizona, United States
• Lynn Institute of the Ozarks — Little Rock, Arkansas, United States
• Baptist Health Center for Clinical Research — Little Rock, Arkansas, United States
• Velocity Clinical Research, Banning — Banning, California, United States
• Hope Clinical Research, LLC — Canoga Park, California, United States
• Marvel Clinical Research — Huntington Beach, California, United States
• Velocity Clinical Research, Chula Vista — La Mesa, California, United States
• Velocity Clinical Research, San Diego — La Mesa, California, United States
• Velocity Clinical Research - Westlake — Los Angeles, California, United States
• Empire Clinical Research — Pomona, California, United States
• Artemis Institute for Clinical Research — Riverside, California, United States
• Benchmark Research-Texas — Riverside, California, United States
• Peninsula Research Associates (PRA) — Rolling Hills Estates, California, United States
• Artemis Institute for Clinical Research — San Diego, California, United States
• Women's Health Care Research Corp. — San Diego, California, United States
• Acclaim Clinical Research — San Diego, California, United States
• Medical Center for Clinical Research — San Diego, California, United States
• Shawn K Hassler MD — San Francisco, California, United States
• West Coast Research LLC — San Ramon, California, United States
• CCT Research — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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