Study of mRNA-1010 Seasonal Influenza Vaccine in Adults (IGNITE P303)
Seasonal Influenza
About this trial
This is an interventional treatment trial for Seasonal Influenza focused on measuring mRNA-1010, Virus Diseases, Flu, Influenza vaccine, Moderna, mRNA vaccine
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 assigned females at birth and 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 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 Day 1. 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, immunosuppressive condition or immune-mediated disease, asplenia, or recurrent severe infections. Participant has tested positive for influenza by local health authority-approved testing methods within 150 days prior to Day 1. Reported history of anaphylaxis or severe hypersensitivity reaction after receipt of mRNA vaccines or any components of the mRNA-1010 or influenza vaccines, including egg protein. Participant has received systemic immunosuppressants for >14 days in total within 180 days prior to Day 1 (for corticosteroids, ≥10 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. Intra-articular and epidural steroid injections are not allowed within 28 days before and/or after study intervention dosing. Participant has received any vaccine authorized or approved by local health agency ≤28 days prior to study intervention dosing (Day 1) or plans to receive a vaccine authorized or approved by local health agency within 28 days before or after study intervention dosing. Participant has received a licensed seasonal influenza vaccine within 5 months (150 days) prior to Day 1. Participant has participated in any investigational seasonal influenza vaccine study within12 months prior to Day 1. Participant is not aware whether they have received an influenza vaccine in the prior 12 months. Participant has donated ≥450 milliliters (mL) of blood products within 28 days prior to Day 1 or plans to donate blood products during the study. Note: Other inclusion and exclusion criteria may apply.
Sites / Locations
- Pinnacle Research Group
- North Alabama Research Center LLC
- Cullman Research Center
- Desert Clinical Research - CCT
- Foothills Research Center - CCT
- Fiel Family & Sports Medicine - PC - CCT
- Baptist Health Center for Clinical Research
- Synexus Clinical Research US, Inc. - Cerritos
- Artemis Institute For Clinical Research LLC - Riverside - Headlands
- Peninsula Research Associates - CRN
- Acclaim Clinical Research
- Chase Medical Research LLC - Waterbury
- Accel Research Site - Deland Clinical Research - ERN
- Velocity Clinical Research - Hallandale Beach
- Indago Research and Health Center
- Health Awareness - Jupiter - ERN
- Accel Research Sites - St. Petersburg - ERN
- Flourish Research - Miami
- Innovation Medical Research Center - ClinEdge
- Synexus Clinical Research US, Inc. - Atlanta
- Atlanta Cardiology and Primary Care
- Accel Research Site - NeuroStudies.net, LLC - ERN
- Javara, Inc./Privia Medical Group Georgia, LLC - Fayetteville - Javara
- Clinical Research Atlanta - ERN
- Flourish Research - Ravenswood
- Synexus Clinical Research US, Inc. - Chicago
- DM Clinical Research - Chicago - ERN
- Meridian Clinical Research (Overland Park - Kansas)
- Meridian Clinical Research (Baton Rouge - Louisiana)
- Javara Research Inc. - Annapolis - Javara
- Clinical Research Institute, Inc - CRN
- Methodist Physicians Clinic - CCT Research
- Meridian Clinical Research (Omaha - Nebraska)
- Midwest Regional Health Services - LLC - CCT
- Meridian Clinical Research (Endwell - New York)
- Tryon Medical Practice - South Park - Javara
- Lucas Research - Morehead City - HyperCore
- CTI Clinical Research Center
- Meridian Clinical Research - (Cincinnati - Ohio)
- Velocity Clinical Research - Grants Pass
- DM Clinical Research - Philadelphia - ERN
- Velocity Clinical Research - Columbia
- Velocity Clinical Research - Gaffney
- DM Clinical Research - Texas Center for Drug Development - Humble - ERN
- Epic Clinical Research
- Clinical Trials of Texas, Inc.
- DM Clinical Research - Sugarland - ERN
- Privia Medical Group Physicians' Group of The Woodlands - Javara
- Cope Family Medicine - CCT
- Olympus Family Medicine - CCT
- J. Lewis Research, Inc., Foothill Family Clinic
- South Ogden Family Medicine - CCT
- Clinical Research Partners LLC - Richmond - ERN
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
mRNA-1010
Licensed Quadrivalent Inactivated Seasonal Influenza Vaccine
Participants will receive a single dose of mRNA-1010 by intramuscular (IM) injection on Day 1.
Participants will receive a single dose of licensed quadrivalent inactivated seasonal influenza vaccine by IM injection on Day 1.