About this trial
This clinical trial will study an investigational seasonal influenza vaccine in adults 18 to 64 years of age. The vaccine is based on messenger ribonucleic acid, also called mRNA. The main goals of the study are to learn how well the vaccine helps the body make an immune response against influenza and what medical problems participants may have after vaccination. Researchers will also compare immune responses in adults 18 to 64 years of age from this study, with immune responses in adults 65 years of age and older from another study. Participants will receive 1 injection into the upper arm muscle and will be followed for about 6 months.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the eDiary, return for follow-up visits, attendance to study contacts, and ability to access and utilize a phone or other electronic communications) independently or with the assistance of a caregiver.
A male or female participant between and including 18 to 64 years of age at the time of study intervention administration
has practiced adequate contraception for at least 30 days prior to study intervention administration, and
has a negative urine pregnancy test within 24 hours prior to study intervention administration, and
Disqualifiers
History of test confirmed influenza infection within 180 days prior to study intervention administration.
Confirmed or suspected immunosuppressive or immunodeficient condition, except for stable human immunodeficiency virus infection meeting protocol-defined stability criteria.
History of myocarditis or pericarditis considered causally associated with the administration of an mRNA vaccine.
History of hypersensitivity or allergic reaction to any previous influenza vaccine.
Trial design
Parallel
Treatments tested in this trial
mRNA Seasonal Flu vaccine
Biological/VaccineOne dose of the mRNA Flu vaccine received intramuscularly.
Comparator 1
Biological/VaccineOne dose of the comparator vaccine received intramuscularly.
Comparator 2
Biological/VaccineOne dose of the comparator vaccine received intramuscularly.
Treatment groups
Trial outcomes
Primary outcomes
Geometric Mean Titer (GMT) of Antigen 1 Titer
GMT of Antigen 2 Titer
Percentage of participants with Antigen 1 seroconversion rate (SCR)
Number of participants with solicited administration site adverse events
Secondary outcomes
GMT of Antigen 1 and Antigen 2 antibodies
Percentage of Participants with Antigen 1 and Antigen 2 antibodies SCR
Geometric Mean Increase (GMI) of Antigen 1 Titer
GMI of Antigen 2 Titer
Sponsors and contacts
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