Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5410 in Adult Participants 18 Years of Age and Older
- Conditions
- Influenza Immunization
- Interventions
- Biological: Quadrivalent Inactivated Influenza High Dose QIV-HDBiological: Quadrivalent Inactivated Influenza Standard Dose QIV-SDBiological: Quadrivalent Recombinant Influenza vaccine RIV4
- Registration Number
- NCT05624606
- 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 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.
- Detailed Description
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.
- 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 IM vaccination based on Investigator's judgment
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM 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 6: QIV-HD Quadrivalent Inactivated Influenza High Dose QIV-HD participants will receive a single dose of QIV -HD vaccine Group 5: QIV-SD Quadrivalent Inactivated Influenza Standard Dose QIV-SD participants will receive a single dose of QIV-SD vaccine Group 1: Quadrivalent Influenza mRNA Vaccine MRT5410 low dose Quadrivalent Influenza mRNA Vaccine MRT5410 participants will receive a single dose (low) of QIV mRNA vaccine Group 2: Quadrivalent Influenza mRNA Vaccine MRT5410 medium dose Quadrivalent Influenza mRNA Vaccine MRT5410 participants will receive a single dose (medium) of QIV mRNA vaccine Group 3: Quadrivalent Influenza mRNA Vaccine MRT5410 high dose Quadrivalent Influenza mRNA Vaccine MRT5410 participants will receive a single dose (high) of QIV mRNA vaccine Group 4: RIV4 Quadrivalent Recombinant Influenza vaccine RIV4 participants will receive a single dose of RIV4 vaccine
- Primary Outcome Measures
Name Time Method Percentage of participants with detectable antibody HAI titers greater than or equal to (≥) 10 [1/dil] Day 1 and Day 29 Number of participants with unsolicited AEs Within 28 days after injection AEs that do not fulfill the conditions of solicited reactions
Number of participants with serious adverse events (SAEs) From Day 1 until Day 366 SAEs reported throughout the study
Percentage of participants with 2-fold and 4-fold rise in HAI titers 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 medically attended adverse events (MAAE)s Within 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
Number of participants with out-of-range biological test results Within 8 days after injection Out-of-range biological test results (including shift from baseline values)
Individual Hemagglutination inhibition (HAI) titer Day 1 and Day 29 Antibody titers are expressed as GMTs at baseline and post-baseline
Number of participants with solicited injection site reactions or systemic reactions Within 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
Individual HAI titer ratio Day 1 and Day 29 Ratios of antibody titers measured by HAI in each group before and after vaccination
Percentage of participants with antibody HAI titers greater than or equal to (≥) 40 [1/dil] Day 29 Number of participants archiving HAI seroconversion against Antigens 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
- Secondary Outcome Measures
Name Time Method Percentage of participants with 2-fold and 4-fold increase in neutralizing titers Day 1 and Day 29 Individual antibodies HAI titer ratio Day 1, Day 91, Day 181 and Day 366 Individual neutralizing antibodies titer ratio 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] Day 91, Day 181 and Day 366 Neutralizing Ab titers Day 1 and Day 29 Neutralizing Ab titers expressed as GMTs
Trial Locations
- Locations (25)
Indago Research and Health Center Site Number : 8400002
🇺🇸Hialeah, Florida, United States
Joint Clinical Trials Huntington Park Site Number : 8400032
🇺🇸Huntington Park, California, United States
Velocity Clinical Research, North Hollywood Site Number : 8400063
🇺🇸North Hollywood, California, United States
Velocity Clinical Research Site Number : 8400024
🇺🇸Meridian, Idaho, United States
Martin Diagnostic Clinic Site Number : 8400058
🇺🇸Tomball, Texas, United States
Investigational Site Number : 6300001
🇵🇷San Juan, Puerto Rico
Research Centers of America Site Number : 8400011
🇺🇸Hollywood, Florida, United States
Palm Beach Research Center Site Number : 8400041
🇺🇸West Palm Beach, Florida, United States
Coastal Carolina Research Center - N Charleston Site Number : 8400007
🇺🇸North Charleston, South Carolina, United States
Meridian Clinical Research Site Number : 8400017
🇺🇸Norfolk, Nebraska, United States
DM Clinical Research Site Number : 8400046
🇺🇸Humble, Texas, United States
Investigational Site Number : 6300002
🇵🇷Barrio Sabana, Puerto Rico
Long Beach Clinical Trials Site Number : 8400056
🇺🇸Long Beach, California, United States
California Research Foundation Site Number : 8400001
🇺🇸San Diego, California, United States
Florida International Research Center Site Number : 8400009
🇺🇸Miami, Florida, United States
Brengle Family Medicine Site Number : 8400040
🇺🇸Indianapolis, Indiana, United States
WR-CRCN, LLC Site Number : 8400060
🇺🇸Las Vegas, Nevada, United States
Clinical Trials of Texas, Inc. - PPDS Site Number : 8400043
🇺🇸San Antonio, Texas, United States
AMR Knoxville Site Number : 8400021
🇺🇸Knoxville, Tennessee, United States
DM Clinical Research - Sugar Land Site Number : 8400045
🇺🇸Sugar Land, Texas, United States
Velocity Clinical Research Site Number : 8400034
🇺🇸Omaha, Nebraska, United States
SIMEDHealth, LLC Site Number : 8400042
🇺🇸Gainesville, Florida, United States
AMR Lexington Site Number : 8400035
🇺🇸Lexington, Kentucky, United States
Elligo Health Research, Inc. Site Number : 8400037
🇺🇸Austin, Texas, United States
Tekton Research, Inc Site Number : 8400051
🇺🇸Austin, Texas, United States