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 mRNA Vaccine MRT5410 compared to an active control (QIV SD, QIV HD \[adults ≥ 65 years of age only\], or RIV4) in adults 18 years of age and older.
Approximately 12 months
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
682
Pharmaceutical form: Liquid frozen solution for injection in a vial Route of administration: Intramuscular
Pharmaceutical form: Liquid suspension for injection in prefilled syringe Route of administration: Intramuscular
Pharmaceutical form: Liquid suspension for injection in prefilled syringe Route of administration: Intramuscular
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 reactions 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: Within 7 days after injection
Number of participants with unsolicited AEs
AEs that do not fulfill the conditions of solicited reactions
Time frame: Within 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: Within 180 days after injection
Number of participants with serious adverse events (SAEs)
SAEs reported throughout the study
Time frame: From Day 1 until 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: Within 8 days after injection
Individual Hemagglutination inhibition (HAI) titer
Antibody titers are expressed as GMTs at baseline and post-baseline
Time frame: 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 prefilled syringe Route of administration: Intramuscular
Joint Clinical Trials Huntington Park Site Number : 8400032
Huntington Park, California, United States
Long Beach Clinical Trials Site Number : 8400056
Long Beach, California, United States
Velocity Clinical Research, North Hollywood Site Number : 8400063
North Hollywood, California, United States
California Research Foundation Site Number : 8400001
San Diego, California, United States
SIMEDHealth, LLC Site Number : 8400042
Gainesville, Florida, United States
Indago Research and Health Center Site Number : 8400002
Hialeah, Florida, United States
Research Centers of America Site Number : 8400011
Hollywood, Florida, United States
Florida International Research Center Site Number : 8400009
Miami, Florida, United States
Palm Beach Research Center Site Number : 8400041
West Palm Beach, Florida, United States
Velocity Clinical Research Site Number : 8400024
Meridian, Idaho, United States
...and 15 more locations
Percentage of participants with detectable antibody HAI titers greater than or equal to (≥) 10 [1/dil]
Time frame: 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: 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: Day 1 and Day 29
Percentage of participants with antibody HAI titers greater than or equal to (≥) 40 [1/dil]
Time frame: Day 29
Percentage of participants with 2-fold and 4-fold rise in HAI titers
Time frame: Day 1 and Day 29
Neutralizing Ab titers
Neutralizing Ab titers expressed as GMTs
Time frame: Day 1 and Day 29
Individual neutralizing antibodies titer ratio
Time frame: Day 1 and Day 29
Percentage of participants with 2-fold and 4-fold increase in neutralizing titers
Time frame: 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: Day 91, Day 181 and Day 366
Individual antibodies HAI titer ratio
Time frame: Day 1, Day 91, Day 181 and Day 366