The purpose of this clinical trial is to learn about the safety and effects of the study vaccine for the potential prevention of influenza. The study vaccine is called Self-Amplifying Ribonucleic Acid vaccine (saRNA vaccine). This study is seeking participants who: * Are between the age of 18 to 49 years old. * Are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. * Are healthy as determined by medical history, physical examinations, and the study doctor. * For male participants, can father children and willing to use an acceptable method of contraception. Female participants who are not of childbearing potential; or male participant not able to father children. * Are capable of giving signed informed consent. Participants will receive either the saRNA vaccine, a licensed Influenza Vaccine (QIV) or a placebo. Participants will not know which vaccine they receive in advance. A placebo does not have any medicine in it but looks just like the study medicine. Participants will receive the study vaccines as a single shot in the arm. We will compare participant experiences to help us determine if the saRNA vaccine is safe and effective. Participants will take part in this study for 6 months. During this time, they will receive the study vaccine and participate in follow-up visits.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
442
Intramuscular injection
Intramuscular injection
Intramuscular injection
Intramuscular injection
Intramuscular injection
Intramuscular injection
Intramuscular injection
Intramuscular injection
Intramuscular injection
Intramuscular injection
Intramuscular injection
Arizona Heart Rhythm Center
Phoenix, Arizona, United States
Hope Research Institute
Phoenix, Arizona, United States
The Pain Center of Arizona
Phoenix, Arizona, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Finlay Medical Research
Greenacres City, Florida, United States
Advanced Pharma CR, LLC
Miami, Florida, United States
Miami Clinical Research
Miami, Florida, United States
Mount Sinai Hospital
Miami Beach, Florida, United States
Panax Clinical Research
Miami Lakes, Florida, United States
Pines Care Research Center, LLC
Pembroke Pines, Florida, United States
...and 15 more locations
Percentage of participants reporting local reactions
Pain at the injection site, redness, and swelling, as self-reported in electronic diaries.
Time frame: For 10 days after vaccination
Percentage of participants reporting systemic events
Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain, as self reported in electronic diaries.
Time frame: For 10 days after vaccination
Percentage of participants reporting adverse events
As elicited by investigational site staff.
Time frame: From vaccination to 4 weeks after vaccination
Percentage of participants reporting serious adverse events
As elicited by investigational site staff.
Time frame: From vaccination to 6 months after vaccination
Percentage of participants with abnormal hematology and chemistry laboratory values
As measured at the central laboratory
Time frame: 2 days after vaccination
Percentage of participants with abnormal hematology and chemistry laboratory values
As measured at the central laboratory
Time frame: 1 week after vaccination
Percentage of participants with grading shifts in hematology and chemistry laboratory assessments
As measured at the central laboratory.
Time frame: Between baseline and 2 days after vaccination
Percentage of participants with grading shifts in hematology and chemistry laboratory assessments
As measured at the central laboratory
Time frame: Between baseline and 1 week after vaccination
Percentage of participants with new electrocardiogram (ECG) abnormalities
ECG abnormalities consistent with probable or possible myocarditis or pericarditis, as judged by a cardiologist
Time frame: 2 days after vaccination
Percentage of participants with new ECG abnormalities
ECG abnormalities consistent with probable or possible myocarditis or pericarditis, as judged by a cardiologist
Time frame: 1 week after vaccination
Geometric mean titers (GMTs) of hemagglutination inhibition (HAI) titers
As measured at the central laboratory
Time frame: At Baseline, and 1-, 2- and 4-weeks after vaccination
Geometric mean fold rise (GMFR) in HAI titers from before vaccination to each subsequent timepoint
As measured at the central laboratory
Time frame: At Baseline, and 1-, 2- and 4-weeks after vaccination
Proportion of participants achieving HAI seroconversion for each strain
As measured at the central laboratory
Time frame: At 1-, 2-, and 4-weeks after vaccination
Proportion of participants with HAI titer >=1:40 for each strain
As measured at the central laboratory
Time frame: At Baseline, and 1-, 2-, and 4-weeks after vaccination
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.