The purpose of this study is to evaluate the safety and immunogenicity of a single intramuscular (IM) injection of up to 3 dose levels of Quadrivalent Influenza messenger ribonucleic acid (mRNA) Vaccine MRT5413 compared to an active control (QIVstandard-dose (SD), QIV high-dose (HD) \[adults ≥ 65 years of age only\], or quadrivalent recombinant influenza vaccine (RIV4)) in adults 18 years of age and older.
Study duration is approximately 12 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
682
Pharmaceutical Form: Liquid frozen solution in a vial Route of Administration: Intramuscular injection
Pharmaceutical Form: Liquid frozen solution in a vial Route of Administration: Intramuscular injection
Pharmaceutical Form: Liquid suspension for injection in pre-filled syringe Route of Administration: Intramuscular injection
Number of participants with immediate adverse events (AEs)
Unsolicited systemic AEs that occur within 30 minutes after vaccination
Time frame: Within 30 minutes after injection
Number of participants with solicited injection site or systemic reactions
Adverse reactions pre-listed in the protocol and case report form (CRF) Injection site reactions: pain, redness, swelling, hardening, bruising Systemic reactions: fever, headache, malaise, myalgia, arthralgia, chills
Time frame: Up to 7 days after injection
Number of participants with unsolicited AEs
AEs that do not fulfill the conditions of solicited reactions
Time frame: Up to 28 days after injection
Number of participants with medically attended adverse events (MAAE)s
AEs with a new onset or a worsening of a condition that prompts the participant or participant to seek unplanned medical advice at a physician's office or Emergency Department
Time frame: Up to 180 days after injection
Number of participants with serious adverse events (SAEs)
SAEs reported throughout the study
Time frame: From Day one to Day 366
Number of participants with out-of-range biological test results
Out-of-range biological test results (including shift from baseline values)
Time frame: Up to 8 days after injection
Individual Hemagglutination inhibition (HAI) titer
Antibody titers are expressed as GMTs at baseline and post-baseline
Time frame: At Day 1 and Day 29
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Pharmaceutical Form: Liquid suspension for injection in pre-filled syringe Route of Administration: Intramuscular injection
Velocity Clinical Research-Chula Vista Site Number : 8400061
Chula Vista, California, United States
Velocity Gardena Site Number : 8400062
Gardena, California, United States
Long Beach Clinical Trials Site Number : 8400052
Long Beach, California, United States
Velocity Clinical Research, North Hollywood Site Number : 8400051
North Hollywood, California, United States
California Research Foundation Site Number : 8400006
San Diego, California, United States
Accel Clinical Research-Deland Clinical Research Unit Site Number : 8400032
DeLand, Florida, United States
Velocity New Smyrna Beach Site Number : 8400063
Edgewater, Florida, United States
SIMEDHealth, LLC Site Number : 8400014
Gainesville, Florida, United States
Indago Research and Health Center Site Number : 8400044
Hialeah, Florida, United States
Cenexel Research Centers of America Site Number : 8400011
Hollywood, Florida, United States
...and 25 more locations
Percentage of participants with detectable antibody HAI titers greater than or equal to (≥) 10 [1/dil]
Time frame: At Day 1 and Day 29
Individual HAI titer ratio
Ratios of antibody titers measured by HAI in each group before and after vaccination
Time frame: At Day 1 and Day 29
Number of participants archiving HAI seroconversion against Antigens
Number of participants with titer \< 10 \[1/dil\] at Day 1 and post-vaccination titer ≥ 40 \[1/dil\] at Day 29, or titer ≥ 10 \[1/dil\] at Day 1 and a ≥ 4-fold-rise in titer \[1/dil\] at Day 29
Time frame: At Day 1 and Day 29
Percentage of participants with antibody HAI titers greater than or equal to (≥) 40 [1/dil]
Time frame: At Day 29
Percentage of participants with 2-fold and 4-fold rise in HAI titers
Time frame: At Day 1 and Day 29
Neutralizing Ab titers
Neutralizing Ab titers expressed as GMTs
Time frame: At Day 1 and Day 29
Individual neutralizing antibodies titer ratio
Time frame: At Day 1 and Day 29
Percentage of participants with 2-fold and 4-fold increase in neutralizing titers
Time frame: At Day 1 and Day 29
Individual HAI Ab titer ratio
Time frame: Day 1, Day 91, Day 181 and Day 366
Percentage of participants with antibody HAI titers greater than or equal to (≥) 40 [1/dil]
Time frame: At Day 91, Day 181 and Day 366
Individual antibodies HAI titer ratio
Time frame: Day 1, Day 91, Day 181 and Day 366