A Study of mRNA-1010 Compared With a Licensed Influenza Vaccine in Adults ≥50 Years of Age
Launched by MODERNATX, INC. · Sep 15, 2024
Trial Information
Current as of May 28, 2025
Active, not recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new flu vaccine called mRNA-1010 to see how safe it is and how well it works compared to a standard licensed flu vaccine. It is specifically looking at adults aged 50 and older, as they are at higher risk for complications from the flu. The trial is currently recruiting participants who can give informed consent and meet certain health criteria, such as not being pregnant and not having had recent illnesses or vaccinations that could affect the study results.
Participants in this trial can expect to receive either the mRNA-1010 vaccine or the standard flu vaccine and will be monitored for any side effects or reactions. It's important to note that those with certain health conditions or recent treatments that could interfere with the study are not eligible to participate. Overall, this trial aims to ensure that the new vaccine is effective and safe for older adults, helping to protect them during flu season.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.
- * Participants who are assigned female at birth or can become pregnant are eligible to participate if:
- • The participant is a person of nonchildbearing potential (PONCBP) or
- * The participant is a person of childbearing potential (POCBP) who:
- • Is not breast/chest feeding.
- • Is using an acceptable contraceptive method at least 28 days prior to Day 1 (Baseline) to at least 90 days after Day 1 (Baseline).
- • Has a negative highly sensitive pregnancy test (urine or serum as required by local regulation or institutional review board \[IRB\]/independent ethics committee \[IEC\]) at the Screening Visit and before study intervention (if the Day 1 \[Baseline\] Visit is not on the same day as the Screening Visit).
- Exclusion Criteria:
- • Acutely ill or febrile (temperature ≥38.0 degrees Celsius (℃) \[100.4° Fahrenheit \[F\]\]) within 72 hours prior to Day 1 (Baseline).
- • Close contact with someone with laboratory-confirmed influenza infection or with someone who has been treated with antiviral therapies for influenza (for example, Tamiflu®/oseltamivir) within 5 days prior to Day 1 (Baseline).
- • History of a diagnosis or condition that, in the judgment of the Investigator, is clinically unstable or may affect participant safety, assessment of study endpoints, assessment of immune response, or adherence to study procedures.
- • Reported history of congenital or acquired immunodeficiency, immunosuppressive condition, asplenia, or recurrent severe infections disease.
- • Tested positive for influenza by local health authority-approved testing methods within 180 days prior to Day 1 (Baseline).
- • History of anaphylaxis or severe hypersensitivity reaction requiring medical intervention after receipt of any of the following: mRNA vaccine or therapeutic; components of an mRNA vaccine or therapeutic; influenza vaccine; or components of an influenza vaccine, including egg protein.
- • Malignancy within 2 years prior to Day 1 (Baseline) (adequately treated basal cell carcinoma and squamous cell carcinoma are allowed).
- • Received corticosteroids at ≥10 milligram (mg)/day of prednisone or equivalent for \>14 days in total within 90 days prior to Day 1 (Baseline) or is anticipating the need for corticosteroids at any time during the study.
- • Received systemic immunosuppressive treatment, including long-acting biological therapies that affect immune responses (for example, infliximab), within 180 days prior to Day 1 (Baseline) or plans to do so during the study.
- • Treated with antiviral therapies for influenza (for example, Tamiflu) within 180 days prior to Day 1 (Baseline).
- • Received any vaccine authorized or approved by local health agency within 28 days prior to Day 1 (Baseline) or plans to do so within 14 days after Day 1 (Baseline).
- • Received a licensed seasonal influenza vaccine within 180 days prior to Day 1 (Baseline) or plans to do so (outside of this study) at any time during the study.
- • Received an investigational seasonal influenza vaccine within 1 year prior to Day 1 (Baseline). Note: participants from mRNA-1010-P304 Season 1 are NOT eligible to re enroll into Season 2.
- • Participated in a clinical study with investigational treatment within 90 days prior to Day 1 (Baseline) based on the medical history interview or plans to do so while participating in this study.
- • Is working or has worked as study personnel or is an immediate family member or house member of study personnel, study staff, or Sponsor personnel.
About Modernatx, Inc.
ModernaTX, Inc. is a pioneering biotechnology company focused on developing transformative medicines based on messenger RNA (mRNA) technology. Established with a commitment to addressing unmet medical needs, Moderna leverages its proprietary platform to create innovative therapies and vaccines for a variety of diseases, including infectious diseases and cancer. The company gained global recognition for its rapid development of an mRNA-based COVID-19 vaccine, showcasing its agility and expertise in the biopharmaceutical landscape. Through robust clinical trials and a commitment to scientific excellence, ModernaTX aims to redefine the future of medicine and enhance patient outcomes worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Incheon, , Korea, Republic Of
Jacksonville, Florida, United States
Walnut Creek, California, United States
Southampton, , United Kingdom
Salt Lake City, Utah, United States
Corvallis, Oregon, United States
Rapid City, South Dakota, United States
Berlin, , Germany
Spartanburg, South Carolina, United States
Fort Worth, Texas, United States
Daejeon, , Korea, Republic Of
Stamford, Connecticut, United States
Waterbury, Connecticut, United States
Uniontown, Pennsylvania, United States
Anniston, Alabama, United States
Saint Louis, Missouri, United States
Seoul, , Korea, Republic Of
Springfield, Missouri, United States
Johnson City, Tennessee, United States
Rochester, New York, United States
Myrtle Beach, South Carolina, United States
Suwon Si, , Korea, Republic Of
Schwerin, , Germany
Dayton, Ohio, United States
Tempe, Arizona, United States
Taichung City, , Taiwan
Salt Lake City, Utah, United States
Birmingham, , United Kingdom
Seoul, , Korea, Republic Of
Blackfoot, Idaho, United States
Austin, Texas, United States
Athens, Alabama, United States
Portland, Oregon, United States
Seoul, , Korea, Republic Of
Edinburgh, , United Kingdom
Genk, , Belgium
Little Rock, Arkansas, United States
Tomball, Texas, United States
Northridge, California, United States
Taipei City, , Taiwan
Columbus, Georgia, United States
Jupiter, Florida, United States
Miami, Florida, United States
Wilmington, North Carolina, United States
Chicago, Illinois, United States
Nottingham, , United Kingdom
Huntsville, Alabama, United States
Redding, California, United States
Wenatchee, Washington, United States
London, , United Kingdom
New Orleans, Louisiana, United States
Meridian, Idaho, United States
Chesterfield, Missouri, United States
South Jordan, Utah, United States
Ansan Si, , Korea, Republic Of
Cullman, Alabama, United States
Berlin, , Germany
Miami, Florida, United States
San Marcos, Texas, United States
Tucson, Arizona, United States
London, , United Kingdom
Plymouth, , United Kingdom
Manchester, Greater Manchester, United Kingdom
Alken, , Belgium
Winter Park, Florida, United States
Riverside, California, United States
Raleigh, North Carolina, United States
Essen, , Germany
Dresden, , Germany
Richmond, Virginia, United States
Miami, Florida, United States
Plano, Texas, United States
Miami Lakes, Florida, United States
Cincinnati, Ohio, United States
Valparaiso, Indiana, United States
Missoula, Montana, United States
Pleven, , Bulgaria
La Mesa, California, United States
San Diego, California, United States
Hamburg, , Germany
Toronto, , Canada
Maitland, Florida, United States
East Syracuse, New York, United States
Gaffney, South Carolina, United States
Lake Mary, Florida, United States
El Paso, Texas, United States
Tbilisi, , Georgia
Hollywood, Florida, United States
Houston, Texas, United States
Glendale, Arizona, United States
Los Angeles, California, United States
Rolling Hills Estates, California, United States
Crystal River, Florida, United States
Hialeah, Florida, United States
Maitland, Florida, United States
Annapolis, Maryland, United States
Gulfport, Mississippi, United States
Salt Lake City, Utah, United States
Levis, , Canada
London, , Canada
Victoriaville, , Canada
Frankfurt, , Germany
Stuttgart, , Germany
Blackpool, , United Kingdom
Corby, , United Kingdom
Honolulu, Hawaii, United States
Kutaisi, , Georgia
Anderson, South Carolina, United States
Santa Ana, California, United States
Southfield, Michigan, United States
Warren, New Jersey, United States
Longmont, Colorado, United States
Philadelphia, Pennsylvania, United States
Columbus, Ohio, United States
Brownsville, Texas, United States
Fort Collins, Colorado, United States
Stockbridge, Georgia, United States
Springfield, Missouri, United States
Charleston, South Carolina, United States
Yukon, Oklahoma, United States
Mobile, Alabama, United States
Exeter, , United Kingdom
Lafayette, Louisiana, United States
Huntington Park, California, United States
Wichita, Kansas, United States
Jackson, Tennessee, United States
Salt Lake City, Utah, United States
Henderson, Nevada, United States
Norfolk, Nebraska, United States
Tulsa, Oklahoma, United States
Southfield, Michigan, United States
Providence, Rhode Island, United States
Southfield, Michigan, United States
Tbilisi, , Georgia
Birmingham, , United Kingdom
Albany, Georgia, United States
Binghamton, New York, United States
Stuhr, , Germany
New Orleans, Louisiana, United States
Vestal, New York, United States
Tomball, Texas, United States
Asheville, North Carolina, United States
Sugar Land, Texas, United States
Sliven, , Bulgaria
Jersey City, New Jersey, United States
Inverness, Florida, United States
Leesburg, Florida, United States
Sioux City, Iowa, United States
Baton Rouge, Louisiana, United States
Gaithersburg, Maryland, United States
Charlotte, North Carolina, United States
Cincinnati, Ohio, United States
Edmond, Oklahoma, United States
Prosper, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Toronto, , Canada
Truro, , Canada
Birmingham, Alabama, United States
Birmingham, Alabama, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Rogers, Arkansas, United States
Colton, California, United States
Covina, California, United States
Long Beach, California, United States
Newport Beach, California, United States
North Hollywood, California, United States
San Bernardino, California, United States
San Diego, California, United States
San Diego, California, United States
Atlantis, Florida, United States
Jacksonville, Florida, United States
Lake City, Florida, United States
Orlando, Florida, United States
Pembroke Pines, Florida, United States
Port Saint Lucie, Florida, United States
Saint Petersburg, Florida, United States
Tampa, Florida, United States
Decatur, Georgia, United States
Savannah, Georgia, United States
Savannah, Georgia, United States
Savannah, Georgia, United States
Chicago, Illinois, United States
Melrose Park, Illinois, United States
Augusta, Kansas, United States
Lenexa, Kansas, United States
Overland Park, Kansas, United States
Monroe, Louisiana, United States
Prairieville, Louisiana, United States
Rockville, Maryland, United States
Rockville, Maryland, United States
Brookline, Massachusetts, United States
Town And Country, Missouri, United States
Missoula, Montana, United States
Grand Island, Nebraska, United States
Lincoln, Nebraska, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Albuquerque, New Mexico, United States
Albuquerque, New Mexico, United States
Brooklyn, New York, United States
Buffalo, New York, United States
Hartsdale, New York, United States
New York, New York, United States
Morehead City, North Carolina, United States
Raleigh, North Carolina, United States
Salisbury, North Carolina, United States
Wilmington, North Carolina, United States
Winston Salem, North Carolina, United States
Cincinnati, Ohio, United States
Charleston, South Carolina, United States
Columbia, South Carolina, United States
Union, South Carolina, United States
Chattanooga, Tennessee, United States
Austin, Texas, United States
Beaumont, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Keller, Texas, United States
San Antonio, Texas, United States
Stephenville, Texas, United States
Sugar Land, Texas, United States
Alexandria, Virginia, United States
Hampton, Virginia, United States
Newport News, Virginia, United States
Portsmouth, Virginia, United States
Winchester, Virginia, United States
Spokane, Washington, United States
Gent, , Belgium
Mechelen, , Belgium
Wilrijk, , Belgium
Burgas, , Bulgaria
Kozloduy, , Bulgaria
Lovech, , Bulgaria
Montana, , Bulgaria
Montana, , Bulgaria
Pazardzhik, , Bulgaria
Plovdiv, , Bulgaria
Plovdiv, , Bulgaria
Plovdiv, , Bulgaria
Sliven, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Stamboliyski, , Bulgaria
Burlington, , Canada
Calgary, , Canada
Ottawa, , Canada
Pointe Claire, , Canada
Québec, , Canada
Red Deer, , Canada
Sarnia, , Canada
Stouffville, , Canada
Trois Rivières, , Canada
Paide, , Estonia
Tallinn, , Estonia
Tallinn, , Estonia
Tallinn, , Estonia
Tartu, , Estonia
Espoo, , Finland
Helsinki, , Finland
Kokkola, , Finland
Oulu, , Finland
Tampere, , Finland
Turku, , Finland
Batumi, , Georgia
Kutaisi, , Georgia
Rustavi, , Georgia
Tbilisi, , Georgia
Berlin, , Germany
Berlin, , Germany
Bochum, , Germany
Frankfurt, , Germany
Frankfurt, , Germany
Hamburg, , Germany
Hannover, , Germany
Karlsruhe, , Germany
Magdeburg, , Germany
Mainz, , Germany
München, , Germany
Offenbach, , Germany
Oldenburg, , Germany
Schleswig, , Germany
Wiesbaden, , Germany
Bucheon Si, , Korea, Republic Of
Wonju Si, , Korea, Republic Of
Kaohsuing City, , Taiwan
Taoyuan City, , Taiwan
Sugar Land, Texas, United Kingdom
Acomb, York, , United Kingdom
Bradford, , United Kingdom
Enfield, , United Kingdom
Glasgow, , United Kingdom
Glasgow, , United Kingdom
London, , United Kingdom
London, , United Kingdom
London, , United Kingdom
London, , United Kingdom
Newcastle Upon Tyne, , United Kingdom
Norwich, , United Kingdom
Peterborough, , United Kingdom
Portsmouth, , United Kingdom
Rochdale, , United Kingdom
Sheffield, , United Kingdom
Stockton On Tees, , United Kingdom
Wirral, , United Kingdom
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported