The purpose of this study is to learn about safety in participants taking the study vaccine (mRNA-based vaccine) and the ability of the study vaccine to trigger the body's immune response, targeting the flu virus (influenza virus). This study is seeking healthy participants 18 years of age or older. All participants in this study will receive only 1 dose in their arm, to deliver one of the experimental flu vaccines or one of the approved flu vaccines used for comparison. Participants will take part in this study for about 6 months, and participants will need to visit the study site at least 3 times. A blood sample will be taken at each of the 3 planned study visits and a swab from inside the nose will be taken at the first study visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
770
Investigational influenza Vaccine
Investigational influenza Vaccine
Investigational Influenza Vaccine
Investigational Influenza Vaccine
Investigational Influenza Vaccine
Investigational Influenza Vaccine
Licensed influenza vaccine
AMR Clinical
Mobile, Alabama, United States
NOT_YET_RECRUITINGDiablo Clinical Research, LLC d/b/a Flourish Research
Walnut Creek, California, United States
RECRUITINGClinical Research Consulting, LLC
Milford, Connecticut, United States
RECRUITINGGeorge Washington Medical Faculty Associates
Washington D.C., District of Columbia, United States
RECRUITINGIndago Research & Health Center, Inc
Hialeah, Florida, United States
RECRUITINGPalm Springs Community Health Center
Miami Lakes, Florida, United States
RECRUITINGClinical Research Atlanta
Stockbridge, Georgia, United States
RECRUITINGEast-West Medical Research Institute
Honolulu, Hawaii, United States
RECRUITINGAMR Clinical
Kansas City, Missouri, United States
NOT_YET_RECRUITINGRochester Clinical Research, LLC
Rochester, New York, United States
RECRUITING...and 5 more locations
Percentage of participants reporting prespecified local reactions following vaccination
Time frame: Within 7 days after vaccination
Percentage of participants reporting prespecified systemic events following vaccination.
Time frame: Within 7 days after vaccination
Percentage of participants reporting adverse events (AEs) following vaccination.
Time frame: Within 1 month after vaccination
Percentage of participants reporting serious adverse events (SAEs) following vaccination.
Time frame: Within 6 months after vaccination
Percentage of participants reporting newly diagnosed chronic medical conditions (NDCMCs) following vaccination.
Time frame: Within 6 months after vaccination
Geometric Mean Titer (GMT) of Anti-Influenza Antibody Levels to each of the influenza antigens of the vaccine.
Time frame: Before vaccination and at 4 weeks after vaccination
Geometric Mean Fold Rise (GMFR) of Anti-Influenza Antibody Levels to each of the influenza antigens of the vaccine
Time frame: Before vaccination to 4 weeks after vaccination
Percentage of participants with satisfactory antibody response to the vaccine.
Time frame: Before vaccination to 4 weeks after vaccination
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