Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5413 in Adult Participants18 Years of Age and Older
- Conditions
- Influenza Immunization
- Interventions
- Biological: Quadrivalent Influenza mRNA Vaccine MRT5413Biological: Quadrivalent Influenza Standard Dose VaccineBiological: Quadrivalent Influenza High-Dose Vaccine
- Registration Number
- NCT05650554
- Lead Sponsor
- Sanofi Pasteur, a Sanofi Company
- Brief Summary
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.
- Detailed Description
Study duration is approximately 12 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 682
-
Aged 18 years on the day of inclusion (US) and aged 21 years on the day of inclusion (Puerto Rico)
-
A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies:
- Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be postmenopausal for at least 1 year, or surgically sterile OR
- Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to study intervention administration until at least 12 weeks after study intervention administration.
Participants are excluded from the study if any of the following criteria apply:
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
- Previous history of myocarditis, pericarditis, and / or myopericarditis
- Self-reported thrombocytopenia, contraindicating Intramuscular vaccination based on Investigator's judgment
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating Intramuscular vaccination based on Investigator's judgment
- Moderate or severe acute illness / infection (according to Investigator's judgment) or febrile illness (temperature ≥ 38.0°C [≥ 100.4°F]) on the day of vaccination. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided
- Self-reported or documented seropositivity for human immunodeficiency virus, hepatitis B virus, or hepatitis C virus
NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 3: Quadrivalent Influenza mRNA Vaccine MRT5413 high dose Quadrivalent Influenza mRNA Vaccine MRT5413 participants will receive a single dose of QIV mRNA vaccine (high dose) Group 5: QIV-SD Quadrivalent Influenza Standard Dose Vaccine participants will receive a single dose of QIV-SD vaccine Group 2: Quadrivalent Influenza mRNA Vaccine MRT5413 medium dose Quadrivalent Influenza mRNA Vaccine MRT5413 participants will receive a single dose of QIV mRNA vaccine (medium dose) Group 6: QIV-HD Quadrivalent Influenza High-Dose Vaccine participants will receive a single dose of QIV -HD vaccine (for elderly only) Group 4: RIV4 Quadrivalent Recombinant Influenza Vaccine participants will receive a single dose of RIV4 vaccine Group 1: Quadrivalent Influenza mRNA Vaccine MRT5413 low dose Quadrivalent Influenza mRNA Vaccine MRT5413 participants will receive a single dose of QIV mRNA vaccine (low dose)
- Primary Outcome Measures
Name Time Method Number of participants with unsolicited AEs Up to 28 days after injection AEs that do not fulfill the conditions of solicited reactions
Number of participants with medically attended adverse events (MAAE)s Up to 180 days after injection 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
Percentage of participants with antibody HAI titers greater than or equal to (≥) 40 [1/dil] At Day 29 Percentage of participants with 2-fold and 4-fold rise in HAI titers At Day 1 and Day 29 Individual Hemagglutination inhibition (HAI) titer At Day 1 and Day 29 Antibody titers are expressed as GMTs at baseline and post-baseline
Individual HAI titer ratio At Day 1 and Day 29 Ratios of antibody titers measured by HAI in each group before and after vaccination
Number of participants archiving HAI seroconversion against Antigens At Day 1 and Day 29 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
Percentage of participants with detectable antibody HAI titers greater than or equal to (≥) 10 [1/dil] At Day 1 and Day 29 Number of participants with immediate adverse events (AEs) Within 30 minutes after injection Unsolicited systemic AEs that occur within 30 minutes after vaccination
Number of participants with solicited injection site or systemic reactions Up to 7 days after injection 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
Number of participants with serious adverse events (SAEs) From Day one to Day 366 SAEs reported throughout the study
Number of participants with out-of-range biological test results Up to 8 days after injection Out-of-range biological test results (including shift from baseline values)
- Secondary Outcome Measures
Name Time Method Neutralizing Ab titers At Day 1 and Day 29 Neutralizing Ab titers expressed as GMTs
Percentage of participants with 2-fold and 4-fold increase in neutralizing titers At Day 1 and Day 29 Individual HAI Ab titer ratio Day 1, Day 91, Day 181 and Day 366 Percentage of participants with antibody HAI titers greater than or equal to (≥) 40 [1/dil] At Day 91, Day 181 and Day 366 Individual antibodies HAI titer ratio Day 1, Day 91, Day 181 and Day 366 Individual neutralizing antibodies titer ratio At Day 1 and Day 29
Trial Locations
- Locations (35)
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
Indago Research and Health Center Site Number : 8400044
🇺🇸Hialeah, Florida, 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
Cenexel Research Centers of America Site Number : 8400011
🇺🇸Hollywood, Florida, United States
Florida Pulmonary Research Center Site Number : 8400036
🇺🇸Winter Park, Florida, United States
Meridian Clinical Research Site Number : 8400022
🇺🇸Savannah, Georgia, United States
Florida International Research Center Site Number : 8400045
🇺🇸Miami, Florida, United States
Suncoast Research Associates, LLC Site Number : 8400060
🇺🇸Miami, Florida, United States
Velocity Clinical Research Site Number : 8400024
🇺🇸Meridian, Idaho, United States
DM Clinical Research - Chicago Site Number : 8400025
🇺🇸River Forest, Illinois, United States
Brengle Family Medicine Site Number : 8400039
🇺🇸Indianapolis, Indiana, United States
Velocity Clinical Research Lincoln Site Number : 8400049
🇺🇸Lincoln, Nebraska, United States
Meridian Clinical Research Site Number : 8400017
🇺🇸Norfolk, Nebraska, United States
Velocity Clinical Research Site Number : 8400008
🇺🇸Omaha, Nebraska, United States
Rochester Clinical Research. Inc. Site Number : 8400027
🇺🇸Rochester, New York, United States
Velocity Clinical Research Site Number : 8400001
🇺🇸Cleveland, Ohio, United States
Velocity Clinical Research - Providence Site Number : 8400019
🇺🇸East Greenwich, Rhode Island, United States
Coastal Carolina Research Center Site Number : 8400042
🇺🇸North Charleston, South Carolina, United States
ClinSearch Site Number : 8400013
🇺🇸Chattanooga, Tennessee, United States
Elligo Health Research, Inc. Site Number : 8400002
🇺🇸Austin, Texas, United States
DM Clinical Research- Bellaire Site Number : 8400026
🇺🇸Houston, Texas, United States
Clinical Trials of Texas, Inc. - PPDS Site Number : 8400016
🇺🇸San Antonio, Texas, United States
Investigational Site Number : 0360004
🇦🇺Darlinghurst, New South Wales, Australia
Investigational Site Number : 0360005
🇦🇺Kanwal, New South Wales, Australia
Investigational Site Number : 0360003
🇦🇺Maroubra, New South Wales, Australia
Investigational Site Number : 0360001
🇦🇺Morayfield, Queensland, Australia
Investigational Site Number : 0360002
🇦🇺North Melbourne, Victoria, Australia
Investigational Site Number : 6300001
🇵🇷Barrio Sabana, Puerto Rico
Investigational Site Number : 6300002
🇵🇷San Juan, Puerto Rico