A Study of mRNA-1010 Seasonal Influenza Vaccine in Adults 50 Years Old and Older
Launched by MODERNATX, INC. · Sep 30, 2022
Trial Information
Current as of April 25, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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.
- Exclusion Criteria:
- • 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.
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
Longmont, Colorado, United States
Winston Salem, North Carolina, United States
Cincinnati, Ohio, United States
Oklahoma City, Oklahoma, United States
Southampton, , United Kingdom
Sofia, , Bulgaria
Rapid City, South Dakota, United States
Berlin, , Germany
Odense, , Denmark
Bath, , United Kingdom
Fort Worth, Texas, United States
Columbus, Georgia, United States
Leiden, , Netherlands
Saint Louis, Missouri, United States
Wilmington, North Carolina, United States
Missoula, Montana, United States
Tainan, , Taiwan
Rochester, New York, United States
Myrtle Beach, South Carolina, United States
Schwerin, , Germany
Tallinn, , Estonia
Barcelona, , Spain
Austin, Texas, United States
Athens, Alabama, United States
Taipei, , Taiwan
Hollywood, Florida, United States
Kaohsiung City, , Taiwan
Morehead City, North Carolina, United States
San Antonio, Texas, United States
Krakow, , Poland
Akron, Ohio, United States
Houston, Texas, United States
Spartanburg, South Carolina, United States
Vigo, , Spain
Metairie, Louisiana, United States
Little Rock, Arkansas, United States
Decatur, Georgia, United States
San Diego, California, United States
Wilmington, North Carolina, United States
Sandy Springs, Georgia, United States
Cincinnati, Ohio, United States
San Diego, California, United States
San Ramon, California, United States
Miami, Florida, United States
Vigo, , Spain
Miami Lakes, Florida, United States
Norfolk, Nebraska, United States
Miami, Florida, United States
Las Vegas, Nevada, United States
Canoga Park, California, United States
Lenexa, Kansas, United States
Jupiter, Florida, United States
Bydgoszcz, , Poland
Meridian, Idaho, United States
Omaha, Nebraska, United States
Toronto, , Canada
Tallinn, , Estonia
Huntington Beach, California, United States
Toronto, , Canada
Little Rock, Arkansas, United States
San Diego, California, United States
Berlin, , Germany
Lublin, , Poland
Pomona, California, United States
Lublin, , Poland
Riverside, California, United States
Skierniewice, , Poland
Raleigh, North Carolina, United States
Essen, , Germany
Dresden, , Germany
Covington, Louisiana, United States
Berlin, , Germany
Richmond, Virginia, United States
Zamosc, , Poland
Wichita, Kansas, United States
Houston, Texas, United States
Hialeah, Florida, United States
Red Oak, Texas, United States
Tempe, Arizona, United States
Chamblee, Georgia, United States
Plano, Texas, United States
Holladay, Utah, United States
Fayetteville, North Carolina, United States
Grand Island, Nebraska, United States
Charlotte, North Carolina, United States
Lincoln, Nebraska, United States
Cincinnati, Ohio, United States
Syracuse, New York, United States
Jacksonville, Florida, United States
Warwick, Rhode Island, United States
Pleven, , Bulgaria
La Mesa, California, United States
Hamburg, , Germany
San Diego, California, United States
Toronto, , Canada
Gaffney, South Carolina, United States
North Las Vegas, Nevada, United States
Banning, California, United States
Las Vegas, Nevada, United States
Baton Rouge, Louisiana, United States
Greenville, South Carolina, United States
Glendale, Arizona, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
La Mesa, California, United States
Los Angeles, California, United States
Riverside, California, United States
Rolling Hills Estates, California, United States
San Francisco, California, United States
Denver, Colorado, United States
Fort Collins, Colorado, United States
Crystal River, Florida, United States
Hialeah, Florida, United States
Inverness, Florida, United States
Lake City, Florida, United States
Lakeland, Florida, United States
Maitland, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Palmetto Bay, Florida, United States
Tampa, Florida, United States
Norcross, Georgia, United States
Savannah, Georgia, United States
Stockbridge, Georgia, United States
Chicago, Illinois, United States
Gurnee, Illinois, United States
River Forest, Illinois, United States
Valparaiso, Indiana, United States
Sioux City, Iowa, United States
Newton, Kansas, United States
New Orleans, Louisiana, United States
Annapolis, Maryland, United States
Rockville, Maryland, United States
Springfield, Massachusetts, United States
Southfield, Michigan, United States
Biloxi, Mississippi, United States
Gulfport, Mississippi, United States
Springfield, Missouri, United States
Elkhorn, Nebraska, United States
Fremont, Nebraska, United States
Norfolk, Nebraska, United States
Omaha, Nebraska, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
Binghamton, New York, United States
Tulsa, Oklahoma, United States
Yukon, Oklahoma, United States
Grants Pass, Oregon, United States
Medford, Oregon, United States
Anderson, South Carolina, United States
Columbia, South Carolina, United States
Hendersonville, Tennessee, United States
Beaumont, Texas, United States
Dallas, Texas, United States
Mckinney, Texas, United States
Sugar Land, Texas, United States
Sugar Land, Texas, United States
Bountiful, Utah, United States
Salt Lake City, Utah, United States
South Ogden, Utah, United States
West Jordan, Utah, United States
Portsmouth, Virginia, United States
Suffolk, Virginia, United States
Kozloduy, , Bulgaria
Montana, , Bulgaria
Montana, , Bulgaria
Sofia, , Bulgaria
Brampton, , Canada
Burlington, , Canada
Hamilton, , Canada
Kelowna, , Canada
Levis, , Canada
London, , Canada
Ottawa, , Canada
Pointe Claire, , Canada
Quebec, , Canada
Quebec, , Canada
Quebec, , Canada
Quebec, , Canada
Quebec, , Canada
Red Deer, , Canada
Saint Charles Borromée, , Canada
Sarnia, , Canada
Toronto, , Canada
Toronto, , Canada
Trois Rivieres, , Canada
Truro, , Canada
Victoriaville, , Canada
Roskilde, , Denmark
århus N, , Denmark
Tallinn, , Estonia
Tartu, , Estonia
Berlin, , Germany
Frankfurt/Main, , Germany
Frankfurt, , Germany
Frankfurt, , Germany
Hamburg, , Germany
Hannover, , Germany
Hannover, , Germany
Heidelberg, , Germany
Köln, , Germany
Leipzig, , Germany
Magdeburg, , Germany
Mainz, , Germany
Oldenburg, , Germany
Stuttgart, , Germany
Wardenburg, , Germany
Utrecht, , Netherlands
Kraków, , Poland
Lodz, , Poland
Warszawa, , Poland
Warszawa, , Poland
Warszawa, , Poland
Zamosc, , Poland
Antequera, , Spain
Barcelona, , Spain
Barcelona, , Spain
Taichung, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
Blackpool, , United Kingdom
Hull, , United Kingdom
Leicester, , United Kingdom
Liverpool, , United Kingdom
London, , United Kingdom
Newcastle, , United Kingdom
Rochdale, , United Kingdom
Rochdale, , United Kingdom
Salford, , United Kingdom
Truro, , United Kingdom
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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